Primary Care Guidelines

My name is Fernando Florido and I am a GP in the United Kingdom. In today’s episode I go through a real-life case of an asymptomatic patient with an isolated raised alkaline phosphatase level. I will describe a recommended approach to investigate and manage them according to guidelines. 

I am not giving medical advice; this video is intended for health care professionals; it is only my interpretation of the guidelines and you must use your clinical judgement.  

There is a YouTube version of this and other videos that you can access here: 

·      The NICE GP YouTube Channel: NICE GP - YouTube 

You can download a summary of my summary / interpretation of the guidance here:  

·      My Summary: https://1drv.ms/b/s!AiVFJ_Uoigq0mC4pm_bYELFa9wEx?e=07p2dJ

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Music provided by Audio Library Plus

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Transcript

Interpreting Isolated Raised Alkaline Phosphatase in Asymptomatic Patients

Hello and welcome. I’m Fernando, a GP in the UK. Today, we're going to explore what to do when we encounter an isolated raised serum Alkaline Phosphatase level in an asymptomatic patient. Please like and subscribe to support the channel.

Right, so let's dive right in!

Introduction

Before we start, let’s remember that Alkaline Phosphatase is present in various tissues, including the liver, bone, kidney, intestine, and placenta. Reference ranges can vary with age and gender, so mild increases may not indicate disease.

Examples of Physiological Causes are:

·      Growth spurts in adolescents

·      Pregnancy in women

·      Age-related increases and

·      Medications like some antibiotics, antiepileptics, antihistamines, oestrogens, and steroids

Some potential causes of isolated raised serum Alkaline Phosphatase include:

·      Congestive cardiac failure

·      Bone diseases

·      Hyperthyroidism

·      End-stage renal disease

Clinical case

So, let’s have a look at our patient. She is a 49-year-old lady who had some blood tests because she was feeling a little tired. Her results came back normal with the exception of an alkaline phosphatase level of 186 (NR 30-130). Physical examination was normal and that there were no signs or symptoms of disease. In addition, she does not drink alcohol at all.

What should be our next steps?

The baseline investigations for someone with an isolated Alkaline Phosphatase are the following tests:

·      Liver function tests adding GGT

·      Calcium and phosphorus adding vit D and PTH

·      Renal and thyroid function tests and

·      A full blood count

We know that the most likely sources of Alkaline Phosphatase are either the bone or the liver. And, in order to differentiate between them, this is why we measure GGT (which is typically elevated in liver issues) and vitamin D levels and PTH levels, which may point towards bone causes.

So, for this patient we will need to repeat the Alkaline Phosphatase levels and checking gamma-GT, vitamin D and parathyroid hormone to try to determine the cause, as well as making sure that the other tests, that is, renal, and thyroid function tests, calcium, phosphorus and a full blood count have also been checked

We will talk more about our patient a little later but now let’s say that, in general terms, if all these tests come back normal, further investigations can be deferred for three months, during which Alkaline Phosphatase levels should be rechecked. Rechecking it earlier than three months is generally unnecessary unless you have specific concerns.

If Alkaline Phosphatase is raised with elevated GGT levels, it's likely of hepatic origin. Further steps that we will need to consider include:

·      Abdominal ultrasound scan (to check for cholestasis and hepatic space-occupying lesions)

·      Antimitochondrial antibodies test (to explore the possibility of primary biliary cirrhosis)

However, if these liver investigations are normal, and the Alkaline Phosphatase level is less than 1.5 times the upper reference limit, observation and monitoring every 3 to 6 months is recommended.

However, if the Alkaline Phosphatase level is more than 1.5 times the upper reference limit and a hepatic origin is suspected, referral for further liver investigations is recommended.

Now, if GGT levels are normal, the raised Alkaline Phosphatase is most likely from a non-hepatic source, often bone-related. This can be due to vitamin D deficiency, Paget's disease of bone, or growth spurts in adolescents.

And how do we manage this? Obviously, if the vitamin D levels are low, we will treat the deficiency accordingly. And if there is any abnormality in the PTH levels, we will also manage it and investigate it further.

If Vitamin D and PTH are normal and if the Alkaline Phosphatase level is less than 1.5 times the upper reference limit and we have no clinical concerns, then observation and monitoring every 3-6 months is usually enough.

However, for those with non-hepatic Alkaline Phosphatase levels more than 1.5 times the normal level, bone scintigraphy may be considered to detect conditions like asymptomatic Paget's disease.

In cases of diagnostic uncertainty and significant increases in serum Alkaline Phosphatase, checking Alkaline Phosphatase isoenzymes will be considered. This will be more precise in determining the origin of the raised levels.

So, there we have it, a guide on what to do when you encounter an isolated raised serum Alkaline Phosphatase level in an asymptomatic patient.

But, what happened to our patient?

Repeat testing showed normal results including GGT, Vitamin D and PTH but the Alkaline Phosphatase went from 186 to 204. Her history and examination remained unremarkable but she started to complain about some abdominal discomfort.

Because of the rise in the Alkaline Phosphatase level and her symptoms, as a precaution, an USS of the abdomen was arranged as well as another check of her Alkaline Phosphatase 6 weeks later.

The results showed that the Alkaline Phosphatase was still high but it had decreased slightly to 191 and her USS showed steatosis of the liver.

So, we conclude that she has non-alcoholic fatty liver disease or NAFLD. Although her liver function tests and GGT results were normal, it is likely that the raised Alkaline Phosphatase level is due to this.

By the way, if you are unsure about how to diagnose and manage NAFLD, please check the corresponding episode on this channel.

By the way, if you are unsure about how to diagnose and manage NAFLD, just click here or in the link that I have put in the episode description which will take you to the corresponding episode on this channel.

And because the Alkaline phosphatase level is less than 1.5 times the upper limit of normal, we will monitor it every 3-6 months.

Remember, that this is not medical advice, it is only my summary of the guidelines consulted and you must use your clinical judgement.

Thanks for watching, and goodbye!

Thank you for listening and goodbye!

My name is Fernando Florido and I am a GP in the United Kingdom. In today’s episode I go through a real-life case of a patient with abnormal Liver Function Tests and non- alcoholic fatty liver disease or NAFLD. I will describe a recommended approach to diagnose and manage them according to guidelines. 

I am not giving medical advice; this podcast is intended for health care professionals; it is only my interpretation of the guidelines and you must use your clinical judgement.  

There is a YouTube version of this and other videos that you can access here: 

·      The NICE GP YouTube Channel: NICE GP - YouTube 

The links to the websites that can calculate these scores are in the episode description:

·      The NAFLD Fibrosis Score (NFS) is available at https://www.thecalculator.co/health/NAFLD-Fibrosis-Score-Calculator-969.html 

·      The Fibrosis 4 (FIB-4) Score available at https://www.mdcalc.com/calc/2200/fibrosis-4-fib-4-index-liver-fibrosis 

You can download a summary of the episode here:  

·      Summary of NAFLD patient case: https://1drv.ms/b/s!AiVFJ_Uoigq0mBYIbok6DSu5vTnY?e=2W11Jd

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Transcript

Hello everyone and welcome. My name is Fernando and I am a GP in the United Kingdom. 

In today’s episode I go through a real-life case of a patient with abnormal Liver Function Tests and non- alcoholic fatty liver disease or NAFLD, describing the recommended approach for its diagnosis and management according to guidelines.

By the way, I am not giving medical advice; this is for health care professionals and it is only my interpretation of the various guidelines consulted so you must use your own clinical judgement.

If you want to download a summary of the episode, the link is in the episode description.

Remember that there is also a YouTube version of these episodes so have a look in the episode description. 

Right, so let’s get straight into it.

Our patient is a 55-year-old man of Hispanic family background who consults you following a routine blood test done one week earlier. This was a repeat blood test because 4 months previously he had been found to have a mildly raised alanine aminotransferase or ALT of 75 (NR 0-55).

The results of all his blood tests were normal with the exception of the ALT which was still high at 65.

His PMH includes:

·      Prediabetes

·      Hyperlipidaemia and

·      Overweight with a BMI of 27.8

His only medication is atorvastatin 20 mg daily for hyperlipidaemia.

He denies alcohol excess. In fact, he is teetotal and does not drink alcohol at all. He has otherwise no symptoms.

In the previous consultation he had been told that raised liver transaminase were not uncommon during the prescribing of statins but that statins need not be stopped for raised liver transaminase levels as long as they are less than 3 times the upper limit of normal.

However, as a result of that consultation, the patient decided to stop the statin of his own accord so he has not been taking it for the last 3 months.

So, in summary, we have a patient with a background of overweight, prediabetes and dyslipidaemia with a slightly elevated ALT for 3 months without an obvious cause.

What should we do?

When we face this situation, we should consider all the possible causes and investigate them fully. But we must primarily consider the most common reason for abnormal liver blood tests in the UK, which is non-alcoholic fatty liver disease, or NAFLD.

This condition happens when excess fat builds up in the liver. But for the diagnosis to be made, we must also exclude other secondary causes.

Let’s quickly remind ourselves that NAFLD has a spectrum that goes from simple hepatic steatosis, meaning that there's fat in the liver, but it's not causing any significant inflammation or damage, to something more serious called non-alcoholic steatohepatitis, or NASH which involves inflammation and injury to liver cells which can lead to liver fibrosis and cirrhosis.

Most people don't have any specific symptoms. However, some might experience fatigue, or mild abdominal discomfort.

In our patient's case, we know that he is overweight, which is typical. However, NAFLD can affect even non-obese individuals. Surprisingly, about 40% of all NAFLD cases worldwide are found in non-obese people, and around 20% in those who are lean.

We also know that NAFLD is closely tied to the metabolic syndrome, involving insulin resistance, obesity, impaired glucose regulation, and hypertension and our patient does have some of these factors. While the exact cause of NAFLD isn't fully clear, it is thought that both environment and genetics play a role.

The outlook for NAFLD depends on the stage of the disease:

• For those with simple steatosis, the outlook is generally positive.
• However, if someone has non-alcoholic steatohepatitis (NASH), they're at higher risk for cirrhosis, liver failure, and even liver cancer.

Complications of NAFLD can be serious. They include:

• Hepatic and metabolic complications and
• Above all, cardiovascular disease, which is the leading cause of death for people with NAFLD.

We should suspect that someone has NAFLD if:

• There are risk factors linked to the metabolic syndrome.
• There are high levels of alanine aminotransferase (ALT) for more than 3 months, and it's usually higher than another enzyme called aspartate aminotransferase (AST).
• They're not consuming excess alcohol, in which case it would be alcoholic fatty liver disease.
• An ultrasound scan reveals a fatty liver.
• They are nor on medication that can cause a fatty liver, e.g. tamoxifen or amiodarone.

So based on all this, we will suspect that our patient could have NAFLD.

How should we confirm the diagnosis?

Next, we'll arrange some more blood tests to get a clearer picture and exclude secondary causes. We will do:

• Liver function tests, to include AST as well as ALT.
• A full blood count, which can help detect low platelets, which is a sign of advanced fibrosis.
• A clotting screen, as it might be off in advanced fibrosis.
• Screening for viral hepatitis B and C, and test for auto-antibodies that could suggest autoimmune hepatitis.
• Ferritin and transferrin saturation to screen for haemochromatosis,
• Serum caeruloplasmin for Wilson's disease,
• Alpha-1-antitrypsin levels to screen for deficiency
• Immunoglobulin (IgA) tissue transglutaminase antibody (tTGA) as coeliac disease can present with cryptogenic liver disease.
• HbA1c, Lipid profile, ESR, CRP, Renal and thyroid function tests as general screening.

Additionally, we could request a liver USS to exclude any other structural issue that we could be missing.

Right, so we organise these tests and we see the patient a few weeks later to discuss the following:

An USS of the abdomen confirms that he has steatosis of the liver.

His blood tests showed that:

ALT has improved but it is still high at 59 (NR 0-55) and AST is also high at 49 (NR 5-34). The rest of his liver function tests were normal.

His FBC was normal with a platelet count of 219 (NR 150-400 10*9/L)

His HbA1c is in the prediabetes range at 43 or 6.1%.

He has normal clotting screen, ESR, CRP, renal and thyroid function tests.

And all other investigations for secondary causes were also normal: viral hepatitis serology, autoantibody screen, ferritin, transferrin saturation, caeruloplasmin, Alpha-1-antitrypsin levels and Immunoglobulin (IgA) tissue transglutaminase antibody (tTGA) as coeliac screen.

His cholesterol was slightly high at 5.1 with an HDL of 1, an LDL of 3.9 and TG of 1.5.

His BP was 147/82 and his CVD risk score using QRISK3 is 8%.

I summary, we have confirmed steatosis of the liver on USS and, given that we have not found secondary causes for the liver function test abnormality, we can conclude that this is indeed NAFLD.

As part of our consultation, we also do a thorough examination looking out for signs of advanced liver disease, of which he has none.

As the next step, we should estimate the level of fibrosis, or scarring of the liver, by using non-invasive tools. There are two simple tests that we can use in Primary care:

·      One, the Fibrosis-4 score or FIB-4, which uses the person's age, AST, ALT, and platelet count.

·      And two, the NAFLD Fibrosis Score (NFS) which measures age, body mass index, blood glucose, platelet count, albumin, and the AST to ALT ratio.

·      The Enhanced Liver Fibrosis (ELF) test is another option but this is really only available in secondary care because of the complexity of the parameters required.

The links to the websites that can calculate these scores are in the episode description:

·      The NAFLD Fibrosis Score (NFS) is available at https://www.thecalculator.co/health/NAFLD-Fibrosis-Score-Calculator-969.html 

·      The Fibrosis 4 (FIB-4) Score available at https://www.mdcalc.com/calc/2200/fibrosis-4-fib-4-index-liver-fibrosis

If the fibrosis score is low, we may be able to manage this patient in Primary Care.

We calculate the FIB4 score for this patient and it is 1.92. which means that further investigations are needed. The interpretation of the scores is as follows:

·      If FIB-4 is < 1.45: we can be reasonably confident that there is absence of cirrhosis

·      If FIB-4 is between 1.45 - 3.25:  the test is inconclusive and

·      If FIB-4 is > 3.25: we can be reasonably confident that there is cirrhosis

So let's move on to the management.

The Primary Care approach would be as follows:

• We will advise lifestyle changes including weight loss, if the person is overweight.
• We will recommend a Mediterranean diet, which can actually reduce liver fat even without weight loss.
• We will encourage moderate-intensity exercise.
• We will offer alcohol advice.
• We will optimise management of co-morbidities such as hypertension, hyperlipidaemia, or type 2 diabetes. In this case, we may revisit his statin therapy because he has two independent risk factors for CVD, prediabetes and NAFLD.
• We need to be aware that statins, if prescribed, don't pose additional liver risks for people with NAFLD. In fact, they can help improve various aspects of the condition.

So, in summary, the primary care approach to NAFLD involves empowering patients to make lifestyle changes, ensuring associated conditions are managed, and offering support and information along the way.

If a person has a working diagnosis of NAFLD and other liver disease causes have been ruled out, and if non-invasive tests indicate a low risk of advanced liver fibrosis (using NFS, FIB-4, or ELF), then primary care management is in order.

However, because his FIB4 score is inconclusive in this case, we will refer him to secondary care for a second opinion.

Other reasons to refer to a Specialist are:

• If there's a high risk of advanced liver fibrosis.
• If there are clear signs of advanced liver disease during examination.
• In cases where there's uncertainty about the diagnosis.

We also need to be aware that specialist management may involve amongst other things:

• Transient elastography, also known as fibroscan, which measures liver stiffness non-invasively, which correlates with the degree of liver fibrosis.
• Liver biopsy.
• In cases of non-alcoholic steato-hepatitis (NASH), pioglitazone, and Vitamin E supplementation might be considered.
• Bariatric surgery, has led to the resolution of steatosis in 66% and fibrosis in 40% of patients.
• Considering liver transplantation. However, NASH recurrence after transplantation is possible.

Finally, this patient should be reviewed regularly in Primary Care. Patients with NAFLD should have an annual review, more frequently if necessary, as per our clinical judgement:

During the review, we will:

• Identify any signs that might indicate liver disease.
• Measure blood pressure and BMI.
• Check liver and renal function, HbA1c and a lipid profile.
• Reassess the CVD risk
• And, every three years, reassess the risk of advanced liver fibrosis and refer if the person has a high risk of advanced liver fibrosis

But remember that this is only a summary and my interpretation of the guidelines.

We have come to the end of this episode. I hope that you have found it useful. Thank you for listening and good-bye 

My name is Fernando Florido and I am a GP in the United Kingdom. In today’s episode I go through the NICE guidelines “Attention deficit hyperactivity disorder: diagnosis and management” or NICE guideline NG87, Published in March 2018 and last updated in September 2019. 

I am not giving medical advice; this video is intended for health care professionals; it is only my interpretation of the guidelines and you must use your clinical judgement.  

There is a YouTube version of this and other videos that you can access here: 

·      The NICE GP YouTube Channel: NICE GP - YouTube 

The full NICE guidance can be found here: 

·      NICE Guideline NG87: https://www.nice.org.uk/guidance/ng87

·      ADHD NICE CKS: https://cks.nice.org.uk/topics/attention-deficit-hyperactivity-disorder/ 

You can download my summaries here: 

·      Summary of NICE guideline NG87: https://1drv.ms/b/s!AiVFJ_Uoigq0mAekn-9SQlZAl5kD?e=WYqHT7

·      Additional Clinical ADHD information: https://1drv.ms/b/s!AiVFJ_Uoigq0mAhXL3J6CRjq5QoD?e=P8cL7K

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Transcript

Hello everyone and welcome. My name is Fernando Florido and I am a GP in the United Kingdom. 

In today’s episode I go through the NICE guidelines on ADHD from a primary care perspective. Make sure that you stay for the whole episode because at the end, I am going to give you additional information on the condition including possible causes, pathophysiology, prognosis and the biochemical reasons why pharmacological treatment is so beneficial in ADHD. 

By the way, I am not giving medical advice; this is for health care professionals and it is only my interpretation of the guidelines so you must use your own clinical judgement. 

If you want to download a copy of my summaries of the NICE guidelines or the additional clinical information, the links are in the episode description.

Remember that there is also a Youtube version of these episodes so have a look in the episode description.  

Right, so let’s get straight into it. 

The guideline covers the recognition, diagnosis and management of ADHD both in children and adults. It is aimed at doctors who specialise in ADHD but I have summarised it focusing on what we need to know in Primary care. 

We should be aware that there is an increased prevalence of ADHD in people:

·      with any mental health condition or conduct disorder

·      with epilepsy or neurodevelopmental disorders

·      with a FH of ADHD

·      who are born preterm or have an acquired brain injury

·      who are looked-after or are known to the Justice System  

But we also need to remember that ADHD is under-recognised in females. 

If a child has symptoms suggestive of ADHD, NICE says that we should refer to secondary care if the symptoms are severe or persist after a period of watchful waiting of up to 10 weeks with group-based ADHD-focused support. This support can be offered without waiting for a formal diagnosis. 

In adults suspected of ADHD we should refer them if they have a childhood diagnosis of ADHD or without a childhood diagnosis if the symptoms are moderate or severe and cannot be explained by other psychiatric diagnoses 

But a diagnosis of ADHD: 

·      Should be made by a specialist.

·      Should not be made solely based on a rating scale.

·      In children, we should assess their parents' or carers' mental health.  

We should offer information about the importance of structure in daily activities and how ADHD could affect their life including relationships and driving because the diagnosis must be declared to the DVLA if it affects safe driving. 

And we should involve, with consent, other healthcare professionals and educational centres so that reasonable adjustments and environmental modifications can be implemented. ADHD is considered a disability and there are legal obligations on employers and education providers to make sure patients are not substantially disadvantaged in their jobs or education. 

Although the management of ADHD is going to be decided by the specialist team, I am going to give a brief outline of what we can expect in Primary Care: 

·      In Patients under 17 years of age, the first line treatment is an ADHD-focused group parent-training programme, followed by medication and CBT if there is significant impairment. Medication should not be offered to children under 5 without a second specialist opinion, preferably from tertiary care.

·      In Adults, CBT and medication should be offered for symptoms that persist after environmental modifications.

·      Examples of environmental modifications may include changes to seating arrangements, changes to lighting and noise, reducing distractions (for example, using headphones), shorter periods of focus with movement breaks, reinforcing verbal requests with written instructions and, for children, the appropriate use of teaching assistants at school. 

In terms of diet, we should not advise elimination of artificial colouring and additives but if there are foods or drinks that appear to influence hyperactive behaviour:

·      They should keep a food diary

·      We will refer to a dietitian if the diary supports a link

·      Any specific dietary elimination should have specialist input. 

We will not advise dietary fatty acid supplementation and we will explain that there is no long-term evidence about a 'few food' diet for children. 

Before starting medication, a full health assessment should be performed, including:

·      Height and weight

·      Pulse and blood pressure

·      A cardiovascular assessment: However, an ECG is not needed before starting stimulants, atomoxetine or guanfacine, if cardiovascular history and examination are normal and the person is not on medicines that increase cardiovascular risk 

A cardiology opinion should be sought before starting medication if there are cardiac concerns of a high BP 

A paediatric hypertension specialist should be involved if the BP is above the 95th centile. 

The recommended medication choices are as follows:

·      For Patients aged 5 to 17 years of age

o  Methylphenidate first line

o  then lisdexamfetamine if methylphenidate ineffective.

o  then dexamfetamine if responding to but not tolerating lisdexamfetamine.

o  Atomoxetine or guanfacine only if previous choices have not been effective or tolerated

·      For Adults

o  We can give Either lisdexamfetamine or methylphenidate first-line

o  Then switch between them if the first choice is ineffective

o  then dexamfetamine if responding to but not tolerating lisdexamfetamine and

o  Atomoxetine is an option if previous choices are not effective or tolerated

·      Unless advised by a tertiary service, the following should not be given:

o  guanfacine for adults

o  clonidine for children

o  atypical antipsychotics in addition to stimulants

o  medication not included in the recommendations

Some considerations when prescribing ADHD medication are:

·      modified-release once-daily preparations are generally preferred

·      Immediate-release preparations offer more flexible dosing during initial titration to determine correct dosing levels but there is more risk of stimulant misuse and diversion

·      A modified-release preparation of methylphenidate in the morning can be used with an immediate-release preparation at another time of the day to extend the duration of effect.

·      We should be aware of the risk of diversion for cognitive enhancement or appetite suppression.

·      After dose stabilisation, prescribing and monitoring of ADHD medication should be carried out under Shared Care Protocol with primary care. 

In terms of general monitoring, apart from monitoring the effectiveness of the medication on ADHD symptoms we should monitor other aspects such as:

·      Height and weight, measuring every 3 to 6 months depending on the patient’s age and we will seek advice if there are clinical concerns

·      Heart rate and blood pressure should be checked before and after each dose change and every 6 months.

·      We will not offer routine blood tests or ECGs unless clinically indicated.

·      Dose adjustments and referral may be necessary if there are cardiovascular concerns

If a person taking stimulants develops tics, we should think about whether:

·      the tics are related to the stimulant (tics naturally wax and wane) and whether

·      the tics outweighs the benefits of ADHD treatment.

·      If tics are stimulant related, the treatment should be reviewed. 

Other possible side effects include:

·      Erectile and ejaculatory dysfunction with atomoxetine.

·      New or worsening seizures: In this case we will stop any medication that might be contributing to the seizures, cautiously reintroducing it if appropriate

·      Disturbance of sleep and behaviour: which may require dose adjustment. 

In terms of supporting adherence to treatment

There is a whole section on this, reminding us to be aware that adherence may be an issue precisely because of the nature of the patients’ ADHD symptoms.

 And finally,

·      ADHD specialists should review medication at least once a year

·      trials of stopping medication or reducing the dose when appropriate should be considered. 

Right, so this is the end of the actual guideline. However, when I read it, I missed a bit more of general clinical information on ADHD and, as promised, let’s cover these areas now: 

And let’s remind ourselves that Attention Deficit-Hyperactivity Disorder is a psychiatric condition that has three subtypes:

1. Predominantly inattentive
2. Predominantly impulsive or hyperactive
3. Combined type

Inattentive symptoms include: lack of attention, lack of concentration, difficulty completing tasks, being forgetful, losing things, etc. Hyperactive symptoms include: fidgeting, leaving their seat, being loud, talking excessively or out of turn, having trouble waiting their turn, etc.

In adults, however, some of the core symptoms may be missing, and they may manifest as other problems such as procrastination, mood instability, and low self-esteem. They will likely be more impulsive or inattentive, as the hyperactivity symptoms can be better controlled.

Different scales are used to measure the symptoms, which can be used in adults to help identify the disorder. However ADHD is a clinical diagnosis and does not have any specific laboratory or radiologic tests. The neuropsychological tests are not always appropriate, and hence it should be diagnosed based upon the history of the patient. 

The aetiology of ADHD includes both a genetic and an environmental component. It is one of the most heritable conditions in terms of psychiatric disorders. Siblings have twice the risk of having ADHD than the general population. Similarly, viral infections, smoking and alcohol during pregnancy and nutritional deficiencies in the foetus have also been explored as possible causes of the disorder. 

ADHD is generally found in a 2:1 male to female ratio but it is thought that it is under-recognised in females. It has also been found that the inattentive subtype is more common amongst the female population. 

From a pathophysiological perspective, ADHD is associated with deficits that relate to frontal lobe activity. Therefore, these patients show disability not only in attention and focus but also in decision making and emotional regulation. There is evidence for the role of dopamine and noradrenaline receptors and pharmacotherapy is directed onto them.  

Pharmacological therapy is divided into two major categories, stimulants and non-stimulants. Stimulants are further broken into amphetamines and methylphenidates. Both types of stimulants block the reuptake of dopamine. Amphetamines also directly release dopamine. Stimulants are the mainstay of treatment for ADHD and they are effective in about 70% of patients. Side effects of stimulants include changes in blood pressure, decreasing appetite and sleep, and risk of dependency. 

Of the non-stimulant option, there are also two types: antidepressants and alpha agonists. Within the antidepressant category, atomoxetine is the best known and works as a selective norepinephrine reuptake inhibitor. It is not nearly as effective as stimulants and it has minimal antidepressant effects. It is often used in children who don't tolerate stimulants or have anxiety. Other antidepressants not endorsed by NICE include bupropion, which targets dopamine and serotonin, and as the last choice, TCAs, which work by targeting norepinephrine.

Finally, alpha agonists such as clonidine and guanfacine can be used but are associated with multiple cardiovascular effects like lowering blood pressure, sedation, weight gain, dizziness, etc. They are found to be more effective in younger children than adults.  

Trigeminal nerve stimulation has recently been shown to be helpful for children not on medications. The device generates a low-level electrical pulse which seems to suppress hyperactivity. 

In terms of prognosis, the general rule of thumb is that 50% of patients will "grow out of" ADHD, especially with treatment, and another 25% do not need treatment into adulthood. The theory is, first, that stimulants help improve the development of the frontal lobe over time, and second, that adults often choose careers that don't require sustained attention so these patients can achieve their vocational goals.

But remember that this is only a summary and my interpretation of the guidelines. 

We have come to the end of this episode. I hope that you have found it useful. Thank you for listening and good-bye 

My name is Fernando Florido and I am a GP in the United Kingdom. In today’s episode I look at Chat GPT generated case of heart failure with co-morbidities to see how the NICE guidelines could apply to it.

I am not giving medical advice; this video is intended for health care professionals; it is only my interpretation of the guidelines and you must use your clinical judgement. 

There is a YouTube version of this and other videos that you can access here: 

·      The NICE GP YouTube Channel: NICE GP - YouTube 

You can download my summary of the guideline with additional information here: 

·      https://1drv.ms/b/s!AiVFJ_Uoigq0l3uRYZ7-U3R808gA?e=2LT5XI

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Transcript

Hello everyone and welcome. My name is Fernando Florido and I am a GP in the United Kingdom.  

In today’s episode I look at the journey from diagnosis to treatment of a ChatGPT generated patient with heart failure and other co-morbidities to see how the NICE guidelines could be applied. Make sure that you stay for the whole episode because at the end, I am going to give you the pathophysiological reasons why ACEIs, ARBs, betablockers and MRA are so beneficial in heart failure, and I am sure that once you have understood it, you will never forget. 

By the way, I am not giving medical advice; this is for health care professionals and it is only my interpretation of the guidelines so you must use your own clinical judgement. 

If you want to download a copy of my summary of the NICE guidelines on Chronic heart failure, the link is in the episode description.

Remember that there is also a Youtube version of these episodes so have a look in the episode description.  

Right, so let’s have a look at our fictitious patient: 

- His Name is: John Smith

- His Age: 68

- Ethnicity: Caucasian

- Past Medical History includes: Obesity, Hypertension, Type 2 Diabetes, and Hyperlipidaemia 

His Current Symptoms are:

- Shortness of breath on exertion and lying down

- a Persistent cough

- Fatigue and weakness

- Bilateral ankle swelling

- And The symptoms have been developing gradually over the last 4-6 months but recently he has noticed more rapid weight gain which could be from fluid retention 

His usual medication is:

- Amlodipine 5 mg OD for hypertension

- Lisinopril 2.5 mg OD for hypertension

- Metformin 500 mg BD for type 2 diabetes and

- Atorvastatin 20 mg OD for hyperlipidaemia 

So, we have a 65-year-old Caucasian male who presents with shortness of breath, fatigue, ankle swelling, and a persistent cough. 

On examination we find the following:  

His BMI is 34, so he is obese.

His Weight is 97 and John says that this is 4Kg more than his usual weight

His BP is 151/92 mmHg and

On auscultation, he has lung crackles. His heart sounds are regular with no murmurs, and his heart rate is 96 bpm. Palpation of the chest reveals a laterally displaced point of maximum impulse consistent with an enlarged ventricle. 

His Oxygen saturation is 98%

And his Peak Flow is: 450 L/min (which is normal for his age and sex)

Abdomen showed no hepatomegaly and there is no raised JVP 

He has Slight bilateral pitting ankle oedema

His Urinalysis and His Temperature are normal  

Right, we have someone with lung crackles and a normal temperature and no other sings of infection, so it would be reasonable to suspect HF rather than bronchopneumonia. His main symptoms are suggestive of left sided heart failure although he also has some ankle oedema which is a possible symptom of right sided heart failure. However, he is also on amlodipine and at this stage we cannot be 100% sure of whether this is a side effect of his medication or secondary to heart failure.  

Let’s remember that typical symptoms of left-sided heart failure include cool clammy skin, cyanosis, a laterally displaced point of maximum impulse consistent with an enlarged ventricle, lung crackles and a gallop rhythm. On the other hand, signs in right sided heart failure include an elevated JVP, ankle of leg oedema, ascites, hepatomegaly, and hepatojugular reflux. Signs of both left and right sided heart failure can be present at the same time.  

In order to confirm the diagnosis of heart failure, we will need to measure the levels of the N-terminal pro-B-type natriuretic peptide, or BNP levels. In addition, and in order to exclude other diagnoses, NICE says that we should also arrange an ECG, a chest X-ray, especially as he has a persistent cough, other blood tests including full blood count, renal, liver, thyroid function, lipid profile, and HbA1c. Peak flow was normal for John but if we are in any doubt about a respiratory condition, we should also request spirometry testing. 

Right, so we are going to send him off to have some tests. Should we be doing anything else in the meantime? 

Well, if we feel that, clinically, he is having signs and symptoms of congestion and fluid retention, NICE says that we should offer diuretics for short term symptomatic relief. So, I would go for a loop diuretic, something like furosemide 20-80 mg daily depending on the severity of the symptoms and, obviously, the higher the dose, the closer that you will want to monitor him. But we should be seeing him again for a review within a day or two.  

I am going to say that his symptoms and signs are significant so I will start him on furosemide 80mg daily and see him in a couple of days or sooner if he does not feel better.  

Right, so, we organise the blood tests, to be done ideally the same day of next day and then we see him again to reassess and discuss the results. 

At the next appointment, John states that his symptoms are better, his breathing is easier and his ability to do physical activities has also improved. On examination 

His weight has gone down to 94.5 Kg but John says that his usual weight is around 93Kg 

His BP is slightly better but still high at 144/87 mmHg. Remember that NICE says that for patients under the age of 80 their target BP should be below 140/90.

On auscultation, there are now minimal crackles at the lung bases and heart sounds are normal and in sinus rhythm with no murmurs. His heart rate is also lower at 80 bpm. 

Oxygen saturation is 99% and

There is also less ankle swelling.  

His Blood tests show that:

• His creatinine is 130 and his eGFR is 75 , so reasonable renal function
• His HbA1c is 60 or 8%
• He has a Normal FBC, LFT and TFTs
• His TC is 4.8, LDL 3.4, HDL 1 and TG 0.9
• And his BNP Level: 800 ng/litre

So, what do we say here?

We know that, if there is no heart failure, we would expect the BNP to be below 400 and therefore, with a raised BNP we can fairly confidently say that this is likely heart failure.  

And because the symptoms have had an insidious onset over several months, we are going to say that he has chronic heart failure rather than anything acute that we should admit him to hospital for. 

It's important to note that the BNP level does not differentiate between heart failure with reduced ejection fraction (or HFrEF) and heart failure with preserved ejection fraction (or HFpEF). We will need to organise an echocardiogram for this.  

Also, we need to be aware that certain factors like obesity, African or African–Caribbean family background, and heart failure drugs can reduce BNP levels. Equally, they may be elevated for other reasons, for example, age over 70 years, ischaemia, tachycardia, hypoxaemia [including PE and COPD], renal failure, diabetes, or liver cirrhosis. John is both obese and has diabetes so he has factors that could be influencing his BNP in both directions.  

His HbA1c is also high so we will need to intensify his diabetes treatment. 

To know if his cholesterol levels on atorvastatin 20 mg are acceptable, we will need to look at his pre statin levels to be absolutely certain that he is on the right dose. 

His other test results show that

- his ECG is normal with no signs of arrhythmia or ischaemia:

- his Chest X-ray shows: Mild pulmonary congestion and

- his Spirometry is also normal ruling out respiratory obstruction or restriction:  

So, with these test results, we will discuss the diagnosis of heart failure with the patient and we will proceed with the referral for a echocardiogram. Because the BNP level is between 400 and 2000 ng/litre, he can have the echocardiogram withing 6 weeks. If it had been over 2000 ng/litre we would need to make urgent to be done within 2 weeks.  

NICE also says that the purpose of the echocardiogram is to exclude valve disease, assess the ventricular function, and detect intracardiac shunts.  

But now that we have a working diagnosis and that we are likely to be waiting for a few weeks for the echocardiogram, we need to start him on some further active treatment. And we have several issues with him:

1.   Hypertension

2.   Chronic heart failure

3.   Diabetes

4.   Lipids and prevention of CVD and

5.   Obesity 

So, let’s start with his hypertension. John is already on step 2 treatment, a combination of two drugs, amlodipine and lisinopril, none of which are at maximal doses. So, should we simply increase the doses of those drugs and then move to step 3 with 3 drugs if necessary? That would be the standard advice on the Hypertension guidelines. But not in his case. 

The NICE guideline on hypertension says that for people with hypertension and CHF we must first follow the guidelines on CHF. So, if the HTA guidelines says that betablockers and spironolactone are considered at step 4 and the CHF guidelines say differently, we need to put the HTA guidelines to one side and give priority to the CHF guideline.  

So, let’s have a look at the guidelines on CHF. What does it say about treatment? You may be familiar with the advice to give ACEIs, betablockers, mineralocorticoid receptor agonists or MRAs etc.  

But these drugs are recommended in HFrEF and the first problem is that we do not know what type of heart failure this patient has. Is it HFrEF or is it HFpEF? Because, when it comes to treatment, the advice for each one can be different. 

Could we assume that it is the most common type of heart failure? Unfortunately, that is not going to work because, at present, about 50% of patients with heart failure have HFpEF and the other 50% HFrEF. 

By the way, remember that heart failure with preserved ejection fraction is characterised by a left ventricular ejection fraction of 50% or more. Heart failure with reduced ejection fraction has an ejection fraction of <40%. And there is now a third type, which NICE refers to as HF with mildly reduced EF which is when the ejection fraction is between 40 and 50%. 

Right, so what do we do?

Well, we could look at the treatment of heart failure from 2 different perspectives:

·      One, Symptomatic treatment

·      And two, Preventative treatment 

Symptomatic treatment addresses the congestive symptoms. And NICE says that we can give Diuretics for the relief of congestive symptoms and fluid retention in both types of HF. We will titrate them up and down according to need but, in particular, NICE says that in heart failure with preserved ejection fraction we will normally give no more than a low to medium dose of loop diuretics (for example, less than 80 mg furosemide per day) and refer if this is not enough.  

The preventative treatment on the other hand is offered in order to reduce morbidity and mortality in the long run and it does not necessarily improve symptoms in the short term. These drugs are ACEIs or ARBs, betablockers, MRAs, ARNIs (which stands for Angiotensin Receptor-Neprilysin Inhibitors) and SGLT2 inhibitors. But all these drugs except the last one, SGLT2 inhibitors, confer these long-term benefits only to HFrEF, and we should not be pushing them if the patient has HFpEF.  

Up to very recently, the same applied to SGLT2 inhibitors but, NICE changed the advice in June 2023 and now recommends dapagliflozin for all types of heart failure. 

So, we conclude that not all drugs recommended for HF with reduced Ejection Fraction are recommended for HF with preserved Ejection Fraction. However, the opposite is true. General management for HFpEF can be applied to HFrEF.  

So, let’s see what drug treatment NICE recommends for HFpEF, which is basically the recommendations for all types of heart failure, and how they apply to our patient:

·      First, as we have already said, we can give low to medium doses of a loop diuretic, say furosemide 20-80 mg daily to relieve symptoms of fluid overload

o  Our patient is on furosemide 80 mg daily and this has had a significant improvement in his symptoms. There are still some fine crackles in both lung fields and I may not rush to reduce the dose too quickly, although a careful reduction could be tried, for example to 60 mg daily advising the patient to increase the dose again if there are worsening of symptoms.

• Second, Dapagliflozin is an option for treating symptomatic chronic heart failure on the advice of a heart failure specialist only
• John still has some symptoms and this drug may be beneficial, but in order to give it for heart failure, we would need to get specialist advice. But we will touch on this a little later.
• Third, We will review drugs which may cause or worsen heart failure and stop them if appropriate- examples of these drugs would be both recreational drugs such as alcohol and cocaine as well as medication such as nonsteroidal anti-inflammatory drugs, beta-blockers, and calcium-channel blockers
• Our patient does not abuse alcohol and on our advice, he will cut down or even stop. He does not use other recreational drugs and he is not taking NSAIDs or betablockers. However, he is taking a calcium channel blocker, amlodipine. Is this going to be a problem?
• NICE says that (Calcium-channel blockers | Treatment summaries | BNF | NICE) calcium channel blockers, with the exception of amlodipine, should be avoided in heart failure as they can further depress cardiac function and exacerbate symptoms and they can also increase mortality after an MI in patients with left ventricular dysfunction and pulmonary congestion.
• So, with that said, our patient does not have to stop amlodipine, which is fortunate because he still needs to for his hypertension. There was a question mark as to whether some of the ankle oedema is secondary to amlodipine but for now, I would leave it as it is and reconsider this prescription later when more information about the patient’s condition is known.
• Number 4, we will consider An antiplatelet drug if there is atherosclerotic CVD (which is not always the case in HF)
• And John does not have this so he does not need aspirin or clopidogrel
• Number 5, we should give A statin if the patient is at risk of atherosclerotic CVD as per the NICE guidelines on CVD prevention
• John has already been found to be at high risk of CV disease and he is already on atorvastatin 20 mg daily. But the guidelines on prevention of CVD state that after statin therapy we should aim for a reduction in non-HDL cholesterol of 40% or more. His current lipids show a TC of 4.8, and an HDL of 1 so his non-HDL cholesterol is 3.8 (TC-HDL). Looking at his previous records we find that before the statin his TC was 5.9 and his HDL was 0.9, therefore then his non-HDL cholesterol was 5. 40% of 5 is 2 so his target non-HDL cholesterol should be 3 and instead it is 3.8. he is not hitting the target of a 40% reduction and I would therefore advise him to increase the dose of atorvastatin to 40 mg daily and recheck his lipids and LFTs again in 3 months.

·     Number 6, part of the CHF management is the Management of other co-morbidities such as hypertension, diabetes, CHD, obesity, AF, COPD etc

o  John has hypertension, obesity and type 2 diabetes as co-morbidities.

o  Let’s look at the hypertension first. He is already on lisinopril and amlodipine and his BP is not down to target. We are worried that his amlodipine may be aggravating his ankle oedema, so I would probably elect not to increase the dose at this stage. However, It would make sense to increase the dose of lisinopril to, for example, 5mg OD, monitoring his BP and renal function. This way, if he has HFrEF, we are titrating one of the medicines that reduce mortality and morbidity in the long run. On the other hand, if he has HFpEF, we will still be managing it correctly by lowering his BP and improving one of his co-morbidities

o  Let’s now look at his diabetes, which is not well controlled with metformin 500 mg BD. NICE says that the first step is always metformin and if metformin is not enough or not tolerated, we will assess the patient’s cardiovascular risk and status. And if the patient has heart failure, atherosclerotic CVD or is at risk of it, we should start and SGLT2 inhibitor.

o  But you may be saying… did we not have to get a specialist opinion before giving an SGLT2 inhibitor for heart failure? And the answer is yes, if you are giving it for heart failure to someone without diabetes. But if the person has diabetes, it is the perfect opportunity to give it and treat both his diabetes and his heart failure, especially as it’s recommended for both HFrEF and HFpEF.

o  But wait a minute, this patient is not on maximal doses of metformin. His eGFR is >60 so his dose could go from 500 mg BD to the maximum, double that, 1000 mg BD. Should we do that first? And my answer would be perhaps at some point. But I would not do this at this stage. Although HF is not a contraindication to metformin, the BNF says amongst other things that “the Manufacturer advises caution in chronic stable heart failure (and to monitor cardiac function), and avoid in conditions that can cause tissue hypoxia.” John’s heart failure is far from stable at the moment so I would not risk increasing the dose of metformin at this stage. With heart failure there may be a degree of tissue hypoxia which could put him at risk of the most feared side effect of metformin, lactic acidosis. In fact, some of you may be thinking that we should have stopped his metformin at the first visit, And perhaps that would have been a good option too, although you would be then be dealing with a whole lot of other issues secondary to uncontrolled hyperglycaemia. Because his oxygen saturation on the first visit was 98% and his condition had developed over many months, I wouldn’t view stopping metformin as an urgent matter. Of course, if he had been truly unwell and hypoxic, that would have been the right thing to do.

o  Another co-morbidity to consider would be his obesity. So, lifestyle advice, maybe orlistat and further referral for support will be indicated at some point. But he has enough on his plate now, so I would park this for the time being and revisit it in future.

• Finally, in HFpEF NICE says that we need to refer if there is poor response to diuretic therapy or if valve disease is discovered.
• But John has responded well to furosemide and auscultation of his heart did not detect any murmurs, so hopefully there will not be anything significant there. But we will have to wait for the echocardiogram report to be completely sure. 

So, in summary:

·      We will continue furosemide either the same dose of 80 mg daily or more likely cautiously reducing it to 40-60 mg according to our clinical judgement, especially considering that

·      We are going to start an SGLT2 inhibitor, which also have a diuretic effect. Something like for example dapagliflozin 10 mg daily would be good.

·      We will also continue amlodipine 5 mg OD and

·      We will increase atorvastatin to 40 mg daily and

·      We will increase lisinopril to 5 mg, monitoring his renal function and

·      We will advise him to continue monitoring his weight and to let us know any concerns 

I would suggest that we see him possibly 7-10 days later to review his progress and medication but we will also give him very careful safety-netting advice to come sooner if anything does not go to plan 

Ok, so, When we see him next, John is feeling very much better, his breathing has improved as well as his tolerance to exercise. 

His weight is now 92.8 which is more like his usual weight.

BP is 138/82 mmHg

On auscultation, his chest is clear and his heart sounds are normal

Oxygen saturation is 99%

Ankle oedema has all but disappeared.

And His renal function has remained reasonably stable although since increasing lisinopril, his eGFR has decreased from 75 to 69 and his creatinine has risen from 130 to 143 

We have also received his Echocardiogram Result which shows:

- that There is evidence of left ventricular hypertrophy, possibly the effect of prolonged hypertension

-Right ventricular function and cardiac valves are normal and there are no cardiac shunts but

- he has a Left ventricular ejection fraction (LVEF) of 35%, so, being <40%, he has HFrEF 

So let’s have a look at the guideline for this. For the treatment of heart failure with reduced ejection fraction NICE says that: 

1. for First-line Treatment we need to give the maximal tolerated doses of:

1.   An ACE inhibitor and

2.   A beta-blocker licensed for heart failure

·      The beta-blockers licensed for heart failure in the UK are bisoprolol, carvedilol, and nebivolol.

·      And We will not withhold betablockers solely based on age or the presence of peripheral vascular disease, erectile dysfunction, diabetes, interstitial pulmonary disease, or COPD.

3.   NICE says that we should use our clinical judgement when deciding which drug to start first. 

4.   But we will not give an ACE inhibitor if there is haemodynamically significant valve disease until the valve disease has been assessed by a specialist.

5.   And We will give an ARB licensed for heart failure if there are side effects with ACE inhibitors. 

·      ARB licensed for heart failure in the UK are Candesartan, losartan, and valsartan.

6.   If there are persistent symptoms, we will then give a mineralocorticoid receptor antagonist (or MRA), such as spironolactone or eplerenone, in addition to an ACE inhibitor (or ARB) and beta-blocker 

OK, so John is already on lisinopril so we should start him on a betablocker next, for example bisoprolol starting at 1.25 mg daily increasing gradually according to the BNF. Also, we should also gradually increase his lisinopril and, as the blood pressure drops, it is likely that we will need to discontinue amlodipine. We will use our clinical judgement as to how quickly the titration of both lisinopril and bisoprolol is but NICE recommends doing so at short intervals (for example, every 2 weeks) until the target or maximum tolerated dose of both drugs is reached.   

But we have noticed that both John’s creatinine and eGFR have deteriorated since we increased the dose of lisinopril. Is that going to be a problem?

NICE says that we only need to worry and take further action if the creatinine level increases by more than 20% or the eGFR falls more than 15%.

John’s creatinine has increased by 10% and his eGFR has only decreased by about 8% so we should not be too concerned but we will keep monitoring it. 

In terms of monitoring, we will do a full clinical assessment at every review, measuring his BP and renal function, including sodium and potassium levels, before and 1 to 2 weeks after starting the drugs, and after each dose increment. We will also assess heart rate when giving betablockers. 

And we will not forget to monitor his HbA1c and his lipids after the management changes. 

NICE says that once the target or maximum tolerated dose is reached, we will monitor the treatment monthly for 3 months and then at least every 6 months, and at any time if he becomes acutely unwell.  

NICE says that we should monitor BNP levels only if:

·      The patient is under 75

·      there is heart failure with reduced ejection fraction and

·      the eGFR is above 60. 

So, we should monitor John’s BNP levels which will help track his response to treatment. 

A follow-up echocardiogram may be performed from time to time to assess if there have been changes in the left ventricular ejection fraction  

If his symptoms do not improve with the initial treatment with an ACEI or ARB and a betablocker, We will consider the addition of Mineralocorticoid Receptor Antagonists (MRA), for example, something like spironolactone 25mg daily increasing to 50 mg, according to response.

I am obviously describing the steps that we would have to follow according to the guidelines but, in practice, we would also refer him to see a cardiologist, early on, to ensure that he gets specialist advice and that his treatment is fully optimised 

For your information, NICE recommends that the following drugs should be initiated by a Specialist only

·      Ivabradine

·      Sacubitril valsartan

·      Hydralazine in combination with nitrate

·      Digoxin 

Other General Recommendations for John will include: 

1. an annual flu vaccination and a one-time pneumococcal vaccination

3. Advise to stop Smoking and reduce alcohol to recommended levels and

6. in terms of Sodium and Fluid Consumption:

   - we will not routinely restrict them but will enquire about his intake and.

   - If John experiences dilutional hyponatremia, fluid restriction may be advised and

   - If John has high levels of salt and/or fluid consumption, he will be encouraged to reduce.

   - And Finally, we will advise him to avoid salt substitutes containing potassium. 

Right, so we will make this the end of this patient’s journey with us.   

But, as promised, let’s talk pathophysiology and the reason why ACEIs, ARBs, MRAs and betablockers have long term benefits in heart failure.

And we will start by saying that Heart failure with reduced ejection fraction, even in its early subclinical stages, leads to reduced organ perfusion, precisely because of the reduced ejection fraction. To compensate for this, the body triggers a response that stimulates the sympathetic system and the RAAS. Stimulation of the sympathetic system produces vasoconstriction and faster and stronger myocardial contractions, whilst the stimulation of the RAAS causes vasoconstriction due to the angiotensin effect and increased fluid and sodium reabsorption due to the aldosterone effect, both of which lead to an elevated blood pressure. Although these mechanisms may initially improve tissue perfusion, they also have a remodelling effect on the heart, eventually inducing harmful structural changes which exacerbate heart failure over time.

The mentioned medications act through different pathways to reduce the heart's workload, enhance cardiac output, and counteract the detrimental effects of the neurohormonal activation. The betablockers do so by blocking the sympathetic system and the ACEIs, ARBs and MRAs by blocking different sections of the RAAS. They are all essential components of evidence-based heart failure management, reducing hospitalisations and mortality.

Given that one of the problems of the RAAS is fluid and sodium retention, you might wonder why patients aren't routinely advised to reduce their fluid and sodium intake. Well, in this world of evidence-based medicine the answer is easy. The reason is that there is currently no research evidence supporting this advice. While it might seem intuitively reasonable, we should refrain from recommending it unless there is concrete evidence indicating that the patient's salt consumption or fluid intake is excessive. 

But remember that this is only my interpretation of the guidelines. 

We have come to the end of this episode. I hope that you have found it useful. Thank you for listening and good-bye 

My name is Fernando Florido and I am a GP in the United Kingdom. In today’s episode I look at a real-life case to demonstrate how the guidelines could apply to it. By way of disclaimer, I am not giving medical advice; this video is intended for health care professionals and you must use your clinical judgement.

The PDF version of this episode can be found here:

·      Colour version: https://1drv.ms/b/s!AiVFJ_Uoigq0l3MBwm5sUpEybW8r?e=xio6pz

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There is a YouTube version of this and other videos that you can access here:

·      The NICE GP YouTube Channel: NICE GP - YouTube

Prescribing information links:

·      Website: https://cks.nice.org.uk/topics/diabetes-type-2/prescribing-information/dpp-4-inhibitors/

·      Download PDF: https://1drv.ms/b/s!AiVFJ_Uoigq0liBvuQq8_0Cd-GSz?e=NnL56J

·      Website: https://cks.nice.org.uk/topics/diabetes-type-2/prescribing-information/glp-1-receptor-agonists/

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Transcript

Hello everyone and welcome. My name is Fernando and I am a GP in the United Kingdom.

We have looked at fictitious patients in previous episodes but, in today’s episode, I am going to look at a real diabetic case to see how the guidelines could apply to it. And as you know, we are focusing only on the pharmacological treatment. If you want to download a PDF version of this episode, the link is in the episode description. 

Please note that I am not giving medical advice; this is only my interpretation of the guidelines and you must use your clinical judgement 

Remember that there is also a Youtube version of these episodes so have a look in the episode description.

Right, so let’s get straight into it. The details, which have been anonymised, belong to a real patient, so we have 46-year-old man of Asian descent with T2DM who presents with the following: 

• HbA1c is 68 mmols/mol/8.4% (therefore poorly controlled) 
• Cholesterol 5.9 
• Triglycerides 5.72 
• HDL 0.97 

·      The path lab has not calculated LDL because triglycerides >4.5 

·      Liver and Renal function tests are normal with an eGFR of 97  

• Thyroid function tests show a borderline low T4 of 9 (NR 9-19.1) and a raised TSH of 9.88 (NR 0.35-4.94 
• ACR normal 
• FBC and other routine blood tests were normal.  
• His BMI is 32, so he is obese 
• His BP is 147/89 
• His PMH includes: 
• Hypothyroidism 
• T2DM 
• His regular treatment is with: 
• Levothyroxine 200mcg daily 
• Metformin 500 mg TDS 

He comes to discuss his test results, feeling well in himself. His obesity is long-standing and being managed with diet and lifestyle advice. He has had hypothyroidism for 15 years and, on prompting, he says that he is feeling a little tired 

So, let’s have a look at the guidelines. As usual I will focus on the NICE guidelines and we will have to looks at the guidelines on type 2 diabetes, hypertension, prevention of cardiovascular disease, and hypothyroidism  

Let’s look at his diabetes first. 

Firstly, NICE says that we need to consider if rescue therapy is necessary for symptomatic hyperglycaemia with insulin or a sulfonylurea. However, he is well and asymptomatic so we do not have to do this. 

We see that his current dose of metformin 500 mg 3 times a day is not enough to control his diabetes. So, given that his renal function is completely normal.  we should increase the dose to the maximum of 2000mg daily, that is, 1000mg twice a day. However, this is unlikely to be enough to bring his HbA1c of 68 or 8.4% to target. And let’s remember that according to NICE we should strive for the following targets: 

·      Lifestyle management only— 48 mmol/mol (6.5%). 

·      A single drug not associated with hypoglycaemia (such as metformin) — 48 mmol/mol (6.5%). 

·      Drug treatment associated with hypoglycaemia (such as a sulfonylurea): 53 mmol/mol (7.0%). 

·      Always adjust for people who are frail, elderly or with other co-morbidities 

This patient is young and otherwise well so we should aim to treat him aggressively. 

NICE says that for people not controlled on metformin alone, we should consider dual therapy but which?  

We need to assess the person's cardiovascular status and risk to determine whether they have chronic heart failure, established atherosclerotic cardiovascular disease, or are at high risk of developing cardiovascular disease. 

This patient does not have heart failure or cardiovascular disease but using an online calculator, his 10-year QRISK3 score is 12%. So, being over 10%, we will consider him at high risk of developing CVD.  

And NICE says that if the patient is at high risk of developing cardiovascular disease, we will consider an SGLT-2 inhibitor with proven cardiovascular benefit in addition to metformin. 

This is good because it seems quite clear that his obesity is a problem and both metformin and SGLT2 inhibitors promote weight loss. 

Because we would want to manage him aggressively, I would advise him to increase metformin straightaway and as soon as we know that it is tolerated, which could be a matter of days, we could start the SGLT2 inhibitor. 

SGLT2 inhibitors with proven cardiovascular benefit includes dapagliflozin, empagliflozin and canagliflozin 

Remember that SGLT2 inhibitors are associated with an increased risk of DKA and lower limb amputation. Therefore, before starting an SGLT2 inhibitor, we need to check whether the person may be at increased risk of diabetic ketoacidosis (DKA), for example if: 

• they have had a previous episode of DKA 
• they are unwell with intercurrent illness 
• Or they are following a very low carbohydrate or ketogenic diet, and if so, not to start the SGLT2 inhibitor until they have changed their diet. We will also advise them not to start this type of diet while they are on this medication.  
• 
  
• The increased risk of lower-limb amputation has been shown with Canagliflozin but there is some concern that the risk may be a class effect. We will need to ensure that foot care is optimised before starting the SGLT2 inhibitor.  
• 
  
• So, this would be my pharmacological action from a diabetic perspective. Increase metformin to 1000mg BD and start an SLGT2 inhibitor, for example, dapagliflozin 10 mg OD. 
• 
  
• Now let’s have a look at his BP, which is elevated at 147/89. 
• 
  
• NICE says that people under the age of 80 should have a BP below 140/90. 
• 
  
• To confirm the diagnosis, we should arrange ambulatory or home blood pressure monitoring and if the average is greater than 135/85 we will start him on antihypertensive treatment. We have more or less established that he does not have end-organ damage because of his normal renal function, normal urinary albumin / creatinine ratio and, looking at his records, normal fundoscopy, as he attends for his annual diabetic retinal screening programme. To be strict, we should also arrange an ECG to ensure that there are no signs of left ventricular hypertrophy.  
• 
  
• Let’s assume that his BP is indeed above the target. What treatment should we start? 
• 
  
• NICE says that for someone with diabetes of any ethnicity and any age, we should start and ACEI or ARB. We know that ACEI confer significant renal protection in diabetes, so we will start him on an ACEI, something like lisinopril 2.5 mg daily, monitoring his renal function and increasing the dose gradually according to our clinical judgement. This patient is of Asian family background but remember that if the patient is of Afro-Caribbean family origin, we should opt for an ARB in preference to an ACEI. This is because Afro-Caribbean patients are considered “low renin responders” and therefore ACEI are less effective in this group. 
• 
  
• Now let’s look at his lipids and what we would do based on the NICE guideline on prevention of cardiovascular disease. 

Firstly, we will calculate his CV risk.Using the online QRISK3 calculator we find that his 10-year risk is 12% Further details are: 

Your 10-year QRISK®3 score 12% 

The score of a healthy person with the same age, sex, and ethnicity 2.6% 

Relative risk** 4.6 

Your QRISK®3 Healthy Heart Age 66 

But remember that NICE also says that the CVD risk may be underestimated by risk assessment tools if the triglyceride levels are raised, which is this patient’s case. 

Could this be treated with lifestyle alone? Because we need to treat him aggressively, I would say no. Furthermore, his cholesterol has been elevated well over 5 mmol/l (200 mg/dL) for the last 3 years so it is clear that diet and exercise alone are not doing the job.  

NICE says that for Primary prevention: 

• If lifestyle modification is ineffective or inappropriate, we will offer a statin, generally atorvastatin 20 mg, for the primary prevention of CVD to people who have a 10% or greater 10‑year CVD risk using the QRISK assessment tool.  
• For people 85 years or older we will still consider atorvastatin 20 mg as statins may be of benefit in reducing the risk of non‑fatal MI. 

Should we do anything different from the point of view of his triglycerides?  

Well, first of all, we will look to see if they have been this high for long. Previous entries show levels moderately elevated but not to this degree. 

Triglycerides are also affected by diabetes control and it may very well be that once his hyperglycaemia improves, and his HbA1c goes down, his triglycerides will too. 

Triglycerides may be also elevated in situations where excess alcohol is consumed. So, we should enquire about this.

And hypothyroidism can also influence lipids in general and triglycerides in particular. Improving his hypothyroidism treatment is also likely to improve the lipid situation.  

Also, atorvastatin will have some effect on the triglycerides, although this effect may not be very pronounced.     

Other drugs like fibrates, such as fenofibrate, are potent agents in reducing triglyceride levels. However, NICE do not recommend their use. In fact, NICE says that: 

• For the prevention of CVD, we should not offer Fibrates, Nicotinic acid, Bile acid sequestrants or Omega‑3 fatty acid compounds, either alone or in combination therapy. 

In summary, I would start him on atorvastatin 20 mg daily and recheck his liver tests and lipids 3 months later, perhaps on a fasting sample, to see if the triglycerides have improved too. Remember that we aim for a greater than 40% reduction in non‑HDL cholesterol and, if this target is not achieved, we will consider increasing the dose. 

And finally, what about his hypothyroidism? He has had it for some time and is on a dose of 200 mcg daily of levothyroxine but his T4 is still on the low side and his TSH is elevated. And he also complains of being tired at times. 

In terms of management of hypothyroidism, NICE says that we should adjust the dose according to symptoms and TFT results, aiming to maintain TSH and T4 levels to within or close to the normal reference range. We should also review the person and recheck TSH levels every 3 months after every dose change. 

The BNF says that for adults under 50 the dose adjustments would be in steps of 25–50 micrograms every 3–4 weeks, according to response. However, a little fly in the ointment is that the BNF recommends the maintenance dose to be up to 200 micrograms once daily. And this is precisely this patient’s dose.  

Sometimes patients do need higher doses but, perhaps we should discuss compliance with him given that it may very well be that he is not taking it regularly and this is why his tests results are not in the normal range.  

Right, so this would be my initial management of this real-life patient: more metformin, dapagliflozin, lisinopril, Atorvastatin and discuss if increasing Levothyroxine is necessary. Remember that this is only my interpretation of the guidelines. 

We have come to the end of this episode. I hope that you have found it useful. Thank you for listening and good-bye 

My name is Fernando Florido and I am a General Practitioner in the United Kingdom. Welcome to the latest instalment in our monthly video series, "NICE News," where we discuss new and updated guidelines published by the National Institute for Health and Care Excellence (NICE), specifically as it relates to primary care.

In this video, I'll be focusing on the NICE guidance and advice published in July 2023. We'll be reviewing the latest recommendations that are relevant to primary care practitioners, with the goal of keeping you informed and up-to-date on the latest developments.  

Please note, I am not giving medical advice; this video is intended for health care professionals, it is only my interpretation of the guidelines and you must use your clinical judgement. 

There is a YouTube version of this and other videos that you can access here: 

• The NICE GP YouTube Channel: https://www.youtube.com/channel/UClrwFDI15W5uH3uRGuzoovw

The link to the PDF version of this video can be downloaded here: 

·      Printable version: https://1drv.ms/b/s!AiVFJ_Uoigq0l2tnS9ulRaEBT8Af?e=TCk7ZO

·      Colour & photo version: https://1drv.ms/b/s!AiVFJ_Uoigq0l2w1zRoLSYM34HhO?e=avMoqf

The links to the update guidance covered can be found here:

Obesity in adults: identification, assessment and management

·      https://www.nice.org.uk/guidance/cg189

KardiaMobile for detecting atrial fibrillation

·      https://www.nice.org.uk/guidance/mtg64

Semaglutide for managing overweight and obesity in young people aged 12 to 17 years (terminated appraisal)

·      https://www.nice.org.uk/guidance/ta910

Alcohol-use disorders: diagnosis and management:

·      https://www.nice.org.uk/guidance/qs11

Draft consultation: Vitamin B12 deficiency in over 16s: diagnosis 6 and management

·      Document: https://www.nice.org.uk/guidance/GID-NG10176/documents/draft-guideline

·      Consultation on draft guideline is open until 5pm on Tuesday 22 August 2023: https://www.nice.org.uk/guidance/indevelopment/gid-ng10176/consultation/html-content

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Transcript

Hello and welcome to another episode of NICE News. My name is Fernando Florido, a GP in the United Kingdom. Today, we'll be discussing the NICE Guidance and advice published in July 2023, specifically for Primary Care.

This month we are focusing on obesity, atrial fibrillation and alcohol misuse. If you want to download a PDF version of this episode, the link is in the episode description.

Before we begin, I want to remind you that this episode is not medical advice. It is only my interpretation, and you must use your clinical judgement.

I'd like to remind you that there is a YouTube version of this episode which can be found in the episode description.

Now, with that said, let’s get straight into it.

The first clinical area refers to the guideline on obesity.

We will refer for bariatric surgery if they:

·     have a BMI of 40 or more, or over 35 with a significant health condition that could be improved if they lost weight

·     The BMI threshold is reduced by 2.5 for South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family background to account for the fact that these groups are prone to central adiposity with cardiometabolic risks at a lower BMI.

And in terms of Pharmacological interventions, NICE has not recommended naltrexone–bupropion but there is a list of three approved medicines for obesity. Liraglutide and semaglutide can only be prescribed for obesity by secondary care and orlistat, which can also be prescribed in primary care. The prescribing criteria are:

·     Liraglutide: BMI of 35 or 32.5 for members of minority ethnic groups

and

Non-diabetic hyperglycaemia (HbA1c level of 42 - 47 mmol/mol [6.0% to 6.4%] or a fasting plasma glucose level of 5.5 - 6.9 mmol/litre)

and

High risk of CVD

·     Semaglutide: BMI of 35.0 or 30.0 if they meet certain referral criteria but reduce BMI thresholds by 2.5 for people from Asian, Chinese, Middle Eastern, Black African or African-Caribbean family backgrounds

and

At least 1 weight-related comorbidity

And we will consider stopping if less than 5% of the initial weight has been lost after 6 months. We will use it for a maximum of 2 years

·     Orlistat: BMI of 30 or more or 28 or more with associated risk factors. It should not be used with other drugs aimed at weight reduction and we should continue beyond 3 months only if the person has lost at least 5% of their initial body weight. However, rates of weight loss may be slower in people with type 2 diabetes, so less strict goals may apply to theml

As a separate guidance NICE is unable to make a recommendation on semaglutide for managing overweight and obesity in people aged 12 to 17 years because the manufacturer considers that, at this time, there is not enough evidence to support it for this population.

The next topic is KardiaMobile for detecting atrial fibrillation

This guidance had been withdrawn because of technical issues but it has now been re-introduced. Therefore KardiaMobile is recommended for detecting atrial fibrillation (AF) for people with suspected paroxysmal AF, who are referred for ambulatory electrocardiogram (ECG). KardiaMobile is a portable ECG recorder and Clinical evidence shows that significantly more people had AF detected using the KardiaMobile single-lead device compared with a Holter monitor. Furthermore, cost modelling shows that KardiaMobile is cost effective.

In terms of alcohol-use disorders there are 5 new quality statements focusing on key areas. The two areas relevant to primary care are that:

1.   Adults who are being asked about their alcohol use have a validated alcohol questionnaire completed to identify any need for a brief intervention or referral to specialist alcohol services. 

2.   Adults seeking help are given information on community support networks and self-help groups. 

I will also mention that there is a first-ever NICE guideline on vitamin B12 deficiency, which at the moment is only in draft form. It basically says that older people with unexplained fatigue or mental health problems should be offered a vitamin B12 test. The draft publication offers recommendations on how to diagnose it and treat it. I will not say much more because, being in draft, it is likely to change, but it is something that we can look forward to in the near future. If you want to see the draft document or take part in their consultation, I have put the link to it in the episode description. 

And lastly, we will end with the sad news that NICE is to stop supplying print copies of the BNF. The guidance will now only be in a digital format, either online or as a mobile app, so if you have one of the printed copies of the BNF lying around, look after it because, given enough time, it may eventually become an important historic item.  

We have come to the end of this episode. I hope that you have found it useful. Thank you for listening and good-bye

My name is Fernando Florido and I am a GP in the United Kingdom. In today’s episode I do a quick review of a mind map that I have created based on the NICE Guideline: Hypertension in adults: diagnosis and management (NG136 guideline), updated on 18th March 2022. I have summarised the guidance from a Primary Care perspective, and I have created an e-book on this too. You are welcome to download both the mind map and both versions of the e-book here:

·      Mind map: https://1drv.ms/b/s!AiVFJ_Uoigq0l2boZjh4biBJ5WGv?e=7YqdBn

·      Condensed and easy to print e-book: https://1drv.ms/b/s!AiVFJ_Uoigq0l2cepU4PPQoY_0NQ?e=xymSS3

·      Digital and fully “clickable” e-book: https://1drv.ms/b/s!AiVFJ_Uoigq0l2iI6yHrZAU0VsWg?e=VtaO9N

By way of disclaimer, nothing that I say either in the video or the downloads is medical advice; this video is intended for health care professionals, it is only my interpretation of the guidelines and you must use your clinical judgement. 

There is a YouTube version of this and other videos that you can access here: 

• The NICE GP YouTube Channel: NICE GP - YouTube 

NICE Guideline NG136 can be found here:

https://www.nice.org.uk/guidance/NG136

Other links relevant to this episode:

·     guideline on hypertension in pregnancy

·     NICE's guideline on cardiovascular disease

·     patient decision aid on treatment options for hypertension

·     NICE's guideline on multimorbidity

·     NICE guidelines on chronic kidney disease

·     type 1 diabetes 

·     MHRA safety advice on ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy, recommendations on how to use for breastfeeding and the related clarification on breastfeeding

·      drug therapy for secondary prevention in the NICE guideline on acute coronary syndromes

·      treatment after stabilisation in the NICE guideline on acute heart failure

·      treating heart failure with reduced ejection fraction in the NICE guideline on chronic heart failure

·      drugs for secondary prevention of cardiovascular disease in the NICE guideline on stable angina

·      blood pressure management in the NICE guideline on type 1 diabetes in adults.

·     NICE's guideline on chronic heart failure

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Script

Hello everyone and welcome. My name is Fernando, a GP in the United Kingdom.

Today, we'll be doing a quick revision on hypertension and we will do it by reviewing a mind map that I have made based on the NICE Guideline on hypertension. Therefore, this episode will be fairly short but make sure that you stay for its entirety because, at the end, I am going to tell you how you can download the mind map and I will also tell you about a mini e-book that I have created that summarises the guidance, as always, from a Primary Care perspective.

Please note that this is my interpretation of the guidelines, not medical advice. Always use your clinical judgement when treating your patients.

There is also a YouTube version which you can find in the episode description.

So, with that said, let's dive in! I hope that you enjoy this episode.

So let me introduce the mind map, and here it is. We are going to quickly navigate through it.

So we’re going to start in the centre of the mind map where it tells us about the guideline NG136. And here we see that it applies to people aged 18 and over, including those with type two diabetes. It also tells us that the updated guideline in March 2022, gives us new targets and new advice on drug treatment for cardiovascular disease. It also reminds us that when measuring the blood pressure we need to consider pulse irregularity when using automated devices, and also we should consider postural hypotension as well as the need to measure the blood pressure in both arms and to repeat the measurement if the difference is greater than 15 mmHg. 

When it comes to diagnosis if the clinic blood pressure is over 140/90 then we will need to arrange ambulatory blood pressure monitoring or alternatively home Blood pressure monitoring and if the average is above 135/85, then we will confirm the diagnosis.

In terms of lifestyle interventions, we will recommend a healthy diet, regular exercise, reduced alcohol, avoid excessive caffeine, as well as low dietary sodium and smoking cessation.

With monitoring we will remember that we need to use the clinic Blood pressure for monitoring purposes although in specific situations ambulatory home blood pressure monitoring may be used and we will base the blood pressure targets on age and comorbidities as well as remembering the need for an annual review of these patients.

When it comes to investigations we will assess for secondary causes, we will estimate the cardiovascular risk and we will assess for target organ damage. This assessment will comprise of at least a urine sample for albumin creatinine ratio, a number of blood tests, fundoscopy and an ECG

For urgent, same day referral we will consider patients with a clinic blood pressure of 180/120 or more with one of the following, either life-threatening symptoms, retinal, haemorrhage, or papilloedema as well as if we suspect pheochromocytoma (pause)

We are now going to focus on the antihypertensive drug treatment and we need to remember that we need to review the treatment when type two diabetes is diagnosed, as well as considering individual factors and medication safety when treating patients and this treatment will follow a stepwise approach. Step one is when we give one drug and this can be an ace inhibitor or ARB if the patient has diabetes, regardless of age and ethnicity. Or if the patient is less than 55 and not of Afro Caribbean family origin or, alternatively we can give a calcium channel blocker is the patient is of Afro-Caribbean family origin and has no diabetes or if the patient is over 55 and has no diabetes

Step two is one we give two drugs and it could be anyone of these combinations, an ace inhibitor or ARB and a calcium channel blocker; an ace inhibitor or arb and a thiazide like diuretic, or a calcium channel blocker, and a thiazide diuretic. Step three is when we give three drugs, and this would be an ace inhibitor, a calcium channel blocker, and a thiazide like diuretic. And step 4 is when we give four drugs. If this happens, we will say that the patient has resistant hypertension and we will consider specialist referral. But if we decide to treat ourselves, we will give triple therapy with an ace inhibitor or arb, a calcium channel blocker, a thiazide like diuretic, and we will check the potassium if the potassium is less than 4.5 we will give. Spironolactone and if potassium is more than 4.5 we will give an alpha blocker or a beta blocker.

And finally, we have a section giving definitions and terms used such as accelerated hypertension, which is when the blood pressure is over 180/120 with retinal involvement, masked hypertension, as well as the three stages of hypertension. 

Right, so this is it, this is the end of the mind map tour. As promised, let me tell you about the downloads. Just click in the episode description and there you will be find a link to download the mind map for free, without the need to provide your email address or any other information. You will also find two other links to download the two versions of the mini e-book that I have created. The first one is a printer friendly e-book, for those of you that would want to have a physical copy in your hands. It is more condensed and has therefore fewer pages. It is in black and white text so you will not be wasting ink unnecessarily on pictures or background colours. The second version is a fully digital “clickable” e-book. It has a few more pages as well as photographs and links to further information. Furthermore, under each section of the mind map there is a button that says “more” and if you click on it, you will be taken directly to the section of the summary that refers to it, followed by a button to take you back to the mind map.

Over the next few episodes, I will be producing more material similar to this so make sure to stay tuned.

But please, let me reiterate again that this is only a summary and my interpretation of the guideline.

We have come to the end of this episode. I hope that you have found it useful. Thank you for listening and good-bye  

The video version of this podcast can be found here:

https://www.youtube.com/watch?v=uXumxdZNU8I&t=1512s

My name is Fernando Florido and I am a GP in the United Kingdom. In today’s episode I summarise and review the various NICE guidance on contraception focusing on the oral methods only. I have summarised the guidance from a Primary Care perspective, at times simplifying some of the guidance to make it manageable.

By way of disclaimer, I am not giving medical advice; this video is intended for health care professionals, it is only my interpretation of the guidelines and you must use your clinical judgement.  

There is a YouTube version of this and other videos that you can access here: 

The NICE GP YouTube Channel: NICE GP - YouTube 

The various guidelines can be found following these links:

·      Summary of “Contraception – assessment” : https://cks.nice.org.uk/topics/contraception-assessment/

·      Scenario: Assessment for contraception: https://cks.nice.org.uk/topics/contraception-assessment/management/assessment-for-contraception/

·      Scenario: Comorbidities and personal characteristics: https://cks.nice.org.uk/topics/contraception-assessment/management/comorbidities-personal-characteristics/

·      Scenario: Assessment for specific contraceptive methods: https://cks.nice.org.uk/topics/contraception-assessment/management/assessment-for-specific-contraceptive-methods/

·      Contraception - combined hormonal methods: https://cks.nice.org.uk/topics/contraception-combined-hormonal-methods/

·      Scenario: Combined oral contraceptive:

https://cks.nice.org.uk/topics/contraception-combined-hormonal-methods/management/combined-oral-contraceptive/

·      Contraception - progestogen-only methods: https://cks.nice.org.uk/topics/contraception-progestogen-only-methods/

·      Scenario: Progestogen-only pill:

https://cks.nice.org.uk/topics/contraception-progestogen-only-methods/management/progestogen-only-pill/

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Transcript 

Hello everyone and welcome. I am Fernando Florido, a GP in the United Kingdom.

Today, we'll be reviewing the various NICE guidelines on contraception focusing on the oral contraception only. I have summarised the guidance from a Primary Care perspective and I have put the relevant links in the episode description.

Please note that this is my interpretation of the guidelines, not medical advice. Always use your clinical judgement when treating your patients.

If you prefer a video format, there’s also a YouTube version of these episodes. The link is in the episode description.

Covering contraception in general is a vast and challenging task. I must admit that there were moments when I felt overwhelmed, as condensing all the necessary information into a concise video seemed nearly impossible, even when focusing solely on oral hormonal contraception. The NICE guidance can be extremely complex, depending on factors such as the woman's place in her hormonal cycle or whether unprotected sexual intercourse has occurred at a specific time. In situations where complexity became unmanageable, I made an effort to simplify the advice while ensuring that the desired contraceptive effect was maintained.

So, with that said, let's dive in!"

The video consists of three parts: an assessment of suitability for oral contraception, information about the combined oral contraceptive, and details about the progesterone-only pill.

Let’s start with the assessment.

How should we start the assessment of a woman requesting oral contraception?

Well, we will

o  Exclude Pregnancy

o  Take a history and clinical examination. 

o  Assess the risk of sexually transmitted infections (STIs) and

o  Assess for sexual abuse, rape, and non-consensual sex especially in vulnerable women

o  Remember that the legal age of consent to sexual activity is 16 years in the UK and that Sexual activity under this age is an offence, even if consensual.

o  If a girl younger than 16 years of age requests contraception without parental consent, she should be assessed for criteria that she is competent to make this decision. In England and Wales these are the Fraser criteria but in different jurisdictions the advice will be different. I have not covered this here and if you come across such a situation, I would advise you to seek medicolegal advice.

We are now going to look at what methods of contraception are suitable for women with certain comorbidities. These sections cover the UK Medical Eligibility Criteria (UKMEC) for hormonal contraception. 

All oral hormonal contraception, that is, the COC and the POP, can be used in the following cases:

·      past or current pelvic inflammatory disease (PID)

·      history of gestational diabetes or diabetes with no vascular disease

·      a BMI of less than 35 

·      non-migrainous headaches

·      migraine without aura but if migraine without aura develops in a woman already using a COC, we should stop it and give an alternative.

·      Fibroids, previous ectopic pregnancy and menorrhagia but obviously women with unexplained vaginal bleeding should be investigated and

·      perimenopausal women, although we will need to consider possible risk factors

The POP can be used but combined oral contraception is not recommended in the following cases: 

·      diabetes with nephropathy, retinopathy, neuropathy, or other vascular disease

·      migraine with aura or with a history of it

·      multiple risk factors for cardiovascular disease

·      BMI of 35 or more

·      Hypertension, even if it is adequately controlled.

·      Current or History of VTE.

·      Major surgery with prolonged immobilization.

·      Family history of VTE in first-degree relative younger than 45 years of age.

·      Immobility for any reason

·      age 35 years or older and a smoker or stopped smoking less than 1 year ago.

In respect of postpartum and breastfeeding

·      POP can be used from day 1

·      COC can be used from 6 weeks

·      Before 6 weeks:

o  We should never use the COC in the first 3 weeks.

o  We will not use the COC before 6 weeks if breastfeeding or if there are risk factors for VTE

o  But the COC can be used from 3 weeks to 6 weeks if not breastfeeding and there are no risk factors for VTE

In respect of girls aged under 18 years

·      We will avoid regular hormonal contraception if non-menstruating girls and.

·      We will recommend barrier methods for the prevention of sexually transmitted infections 

Finally, in respect of the POP

·      We will check that the cervical screening is up to date and.

·      We will check the additional considerations for drospirenone like:

o  Not to be used in renal failure.  

o  To be avoided in hyperkalaemia or at risk of developing it and

o  To have UEs and BP monitored depending on risk factors

How should we follow up women on oral contraception, both the COC and the POP?

·      We should do a review 3 months after the first prescription, and annually thereafter.

·      At follow up visits we will:

o  Check BP and BMI.

o  Ask about headaches, especially migraine. 

o  Assess for any new risk factors.

o  Address any issues or adverse effects.

o  Check the patient’s knowledge and remind about possible drug interactions and

o  Advise about long-acting reversible contraception

·      We should stop COC at 50 years of age, and switch to and alternative such as the POP.

Before looking at the COC and the POP separately, let’s look at how we would manage a patient taking oral contraception who develops unscheduled bleeding.

·      We need to know that unscheduled bleeding is common in the first 3 months of starting the COC and in women taking the POP

·      We will always need to check for:

o  missed pills, drug interactions, and vomiting or diarrhoea.

o  STIs and as a minimum, we should test for Chlamydia trachomatis.

o  Pregnancy and we should do a pregnancy test and.

o  Gynaecological conditions such as cervical or endometrial cancer.

·      We will consider a speculum and pelvic examination if there are concerns and

·      If all is normal, the bleeding can be assumed to be caused by the COC or POP:

o  If on the COC and the bleeding does not settle, we will consider:

▪       a different COC (with a higher dose of oestrogen, or higher dose of progestogen, or different type of progestogen).

▪       another form of contraception.

o  If on the POP we will advise that

▪       although bleeding may settle with time, there is no evidence to indicate who may become amenorrhoeic, and who may experience persistent irregular bleeding.

▪       If the bleeding is unacceptable to the patient, we will consider changing to:

▪       A different POP, although there is no evidence that changing improves bleeding or

▪       A different type of contraceptive method. 

We are now going to look at the combined oral Contraception

·      Let’s remember that COC inhibit LH and FSH which stops ovulation from occurring.

·      In addition, COCs also have contraceptive effects on cervical mucus and the endometrium

·      The usual 7-day break causes vaginal bleeding mimicking menstruation. However, there is no health benefit from this and women can choose to take fewer, or no, breaks.

·      When used perfectly, there’s a 0.3% failure rate within the first year. But in the real world the failure rate can go up to 9%.

When can a woman start using a combined oral contraceptive?

·      If the COC is started on days 1–5 of the menstrual cycle: 

o  No additional contraception is required unless the woman is starting Qlaira® or Zoely®.

o  If the woman is starting Qlaira® or Zoely®, on day 1 of the menstrual cycle then no additional contraception is required

o  But if the woman is starting Qlaira® or Zoely®, on day 2-5 of the menstrual cycle we should advise a barrier method for the first 9 days (for Qlaira) or the first 7 days (for Zoely).

·      If the COC is started at any other time in the menstrual cycle:

o  We will advise a barrier method for the first 7 days (9 days for Qlaira®).

·      If pregnancy cannot be excluded and the woman wishes to start hormonal contraception without delay:

o  We will prescribe the COC and advise a pregnancy test no sooner than 3 weeks after the last episode of unprotected sexual intercourse (UPSI).

If the woman is starting a COC after oral emergency contraception:

·      For levonorgestrel, we will start the COC immediately and we will advise a barrier method for the first 7 days (9 days if taking Qlaira®).

·      For ulipristal, we will start the COC 5 days after and we will advise a barrier method for this time and the next 7 days (9 days if taking Qlaira®).

If the woman is switching from another COC, the combined contraceptive patch, or the combined vaginal ring:

·      We will start the COC on the day after the last active pill, patch, or vaginal ring. There is no need to wait for the next menstrual period. 

o  No additional contraception is required.

·      If the woman decides to take the usual break before starting the new COC, we will need to assess the need for additional contraception and emergency contraception.

If the woman is switching from a progestogen-only pill (except desogestrel) or levonorgestrel intrauterine system (LNG-IUS):

·      We will start the COC at any time in the menstrual cycle and advise a barrier method for the first 7 days (9 days for Qlaira®).

The advice on how to switch from the drosperidone progestogen-only pill, a progestogen-only implant, or a copper intrauterine device can be fairly complex depending on various factors and these patients may very well be managed by family planning clinics so I will not cover them here. But feel free to check the links in the episode description if you wish to know more. 

If the woman is amenorrhoeic but not pregnant:

·     we can start the combined oral contraceptive at any time, and additional contraception is required for 7 days (9 days for Qlaira®).

If the woman is postpartum:

·     we will advise a barrier method for the first 7 days (9 days for Qlaira®).

If the woman has had a miscarriage or termination of pregnancy:

·      If gestation is less than 24 weeks:

o  If the COC is started within 5 days (except Qlaira® and Zoely® which is 1 day). No additional contraception is required.

o  If the COC is started at any other time, use a barrier method for 7 days (9 days for Qlaira®).

·      If gestation is 24 weeks or more, we will treat them as if they were postpartum.

What types of combined oral contraceptive (COC) are available?

·      Combined oral contraceptives (COCs) contain both an oestrogen and a progestogen.

·      COC preparations differ according to:

o      How the doses vary over the menstrual cycle. For example

▪       In monophasic COCs, the amount of oestrogen and progestogen in each active tablet is constant throughout the cycle.

▪       In phasic COCs, the amounts of oestrogen and progestogen vary over the cycle. Phasic COCs can be biphasic, triphasic, or quadraphasic depending on the number of sets of active pills.

o      They can also vary depending on the dose of the oestrogen. For example

▪       Low-strength COCs contain 20 micrograms of ethinylestradiol. and

▪       Standard-strength preparations contain 30–35 micrograms of ethinylestradiol in monophasic COCs and 30–40 micrograms in phased preparations.

o      They also vary according to the type of progestogen they contain. and

o      The presence or absence of a pill-free interval.

▪       Most COCs are packaged as 21 active tablets to allow for a 7 day break every 4 weeks. However, some products have 7 placebo tablets so that a tablet is taken every day without a break

Which combined oral contraceptive (COC) should we offer first-line?

·      First-line options are monophasic preparations containing 30 micrograms of oestrogen, plus either norethisterone or levonorgestrel. Examples are Loestrin 30, Microgynon 30, Ovranette, Levest and Rigevidon

·      However, any COC can be offered first-line.

·      We should prescribe up to 12 months’ supply for initiating or continuing CHC. And

·      You can check the full availability of brands by looking at the BNF. 

Let’s look at the advice that we should give women taking the COC.

If a woman becomes pregnant while taking the combined oral contraceptive (COC) pill and she wishes to continue with the pregnancy:

o  We will stop the pill.

o  And explain that there is no evidence of harm if pregnancy occurs whilst on the COC. 

What are the advantages and disadvantages associated with combined oral contraceptives (COCs)?

Advantages are that

·      There is a reduced risk of some cancers, including colorectal, ovarian and endometrial cancer. 

·      There is a reduced risk of ovarian cysts and benign ovarian tumours.

·      There is reduced severity of acne in some women.

·      Normal fertility returns immediately after stopping the COC.

·      COCs may also reduce the risk of benign breast disease and osteoporosis, although the available evidence is conflicting.

Disadvantages are that

·      They are less effective than long-acting reversible methods of contraception and that

·      Some women experience adverse effects .

·      The most commonly reported adverse effects are: 

o  Nausea and abdominal pain.

o  Headache.

o  Breast pain and/or tenderness.

o  Menstrual irregularities in up to 20% of COC users

·      Other adverse effects include:

o  Hypertension.

o  Changes in lipid metabolism.

o  there is a very small increase in risk of MI, and two-fold increase in risk of stroke, which is greater in at risk patients.

o  There is an increased risk of VTE, but the absolute risk is very low and lower than the risk of VTE in pregnancy.

o  The risk of VTE depends on the progestogen component and:

▪       levonorgestrel, norethisterone, or norgestimate have the lowest risk

o  There is an increased risk of breast and cervical cancer which returns to normal within 10 years after stopping the COC.

o  depression is a known side effect

o  symptoms of angioedema may be induced or exacerbated by exogenous oestrogens

o  There is no evidence that COCs cause weight gain or loss of libido.

o  In addition, co-cyprindiol should not be used in hepatic disease and meningiomas have been associated with cyproterone.

We also need to be aware of drug interactions and that the effect of COC may be reduced with liver enzyme-inducing drugs like:

o  Antibiotics such as rifampicin and rifabutin.

o  Antiepileptic drugs.

o  Antiretrovirals.

o  St John's wort.

How should we manage them?

·      We should advise not to take products containing St John’s wort.

·      We should always change to an alternative contraceptive method if taking rifampicin or rifabutin. For other liver enzymes drugs the advice may be more complex depending on the duration of treatment and type of COC used. I would recommend that you look up the specific advice depending on the situation

·      We need to be aware that breakthrough bleeding may indicate low serum ethinylestradiol concentrations. If other causes of bleeding have been excluded, we could increase the dose up to a maximum of 70 micrograms.

·      We will consider the need for emergency contraception if sexual intercourse has taken place while the efficacy of the COC may have been reduced.

·      To reduce the risk of contraceptive failure, we can recommend either: 

o      An extended regimen that is, using the COC continuously until breakthrough bleeding occurs for 3 to 4 days or

o      A tricycling regimen with a shortened pill-free interval of 3–4 days, that is taking 3 pill packs continuously without a break.

·      But we need to remember that only monophasic 21-day pill packs containing at least 30 micrograms of ethinylestradiol are suitable for these two options. 

In terms of surgery, we should explain that

·      No precautions are necessary for minor surgery (such as varicose vein surgery, and tooth extraction). But

·      The COC should be stopped: 

o  Four weeks before any major surgery (which includes operations lasting more than 30 minute), all surgery to the legs, or surgery that involves prolonged immobilization of a lower limb or

o  If emergency surgery or immobilization (such as for a leg fracture) is necessary.

o  The COC can then be restarted 2 weeks after full mobilization. 

Let’s now go through what Missed pill advice we should give and 

These missed pill rules apply to all combined oral contraceptives (COCs) except Qlaira® and Zoely®.

·      If it has been 9 completed days or more since the last active pill was taken we will consider emergency contraception if unprotected sexual intercourse (UPSI) has taken place and:

o  We will advise to take the missed pill as soon as possible and to continue taking the remaining pills at the usual time.

o  We will advise a barrier method until 7 consecutive pills have been taken. 

o  We will consider a follow up pregnancy test.

·      If one pill has been missed (that is <72 hours since the last pill was taken), we will advise:

o  That emergency contraception and additional contraceptive precautions are not required if there was otherwise consistent, correct use.

o  To take the missed pill as soon as possible.

o  To continue taking the remaining pills at the usual time. This may mean taking two pills in 24 hours (the missed pill and the next one at the usual time).

·      If 2–7 pills have been missed (72 hours or more since the last pill in the current pack was taken):

o  We will consider emergency contraception if the missed pills were in week 1 after the break and if UPSI has taken place and we will also consider a follow up pregnancy test.

o  Emergency contraception is not needed if missed pills are in subsequent weeks if there was consistent, correct use in the previous 7 days.

o  We will advise to take the most recent missed pill as soon as possible. Any earlier missed pills should be ignored.

o  We will advise to continue taking the remaining pills at the usual time. This may mean taking two pills in 24 hours.

o  If there were two or more missed pills in the 7 days prior to the break, to omit the break.   

o  We will advise a barrier method until 7 consecutive pills have been taken. 

·      If more than 7 consecutive COC pills have been missed in any week of pill-taking:

o  We will Consider emergency contraception and an immediate and follow up pregnancy tests.

o  We will Restart the COC as a new user. And

o  We will advise a barrier method until 7 consecutive pills have been taken.

What advice should we give a woman who has missed pills of Qlaira or Zoely

·      If the pill is taken less than 12 hours late (Qlaira) or 24 hours late (Zoely) we will advise:

o  To take the missed pill immediately.

o  To take further pills at the usual time.

o  That additional contraception is not required.

·      If pill is taken more than 12 hours late (Qlaira) or 24 hours late (Zoely), management will depend on the day of the cycle on which it has been missed. This can get quite complicated so I have not included it here and I recommend that you look it up if you come across this situation. 

How should vomiting or diarrhoea be managed when on the COC?

·      Well, for all combined oral contraceptives (COCs) except Qlaira® and Zoely®:

o  If there is vomiting within 3 hours of taking COC, another pill should be taken as soon as possible.

o  If vomiting or diarrhoea persists for more than 24 hours:

▪       We will follow the instructions for missed pills, counting each day of vomiting and/or diarrhoea as a missed pill.

▪       We will advise a barrier method during the illness and for 7 days afterwards. and

▪       if the illness occurs while taking the last 7 pills, we will recommend not having a break and starting the next cycle immediately.

·      For Qlaira® and Zoely®:

o  If a woman vomits within 3–4 hours of taking an active pill, take the next tablet as soon as possible.

o  If more than 12 hours elapse for Qlaira® or 24 hours for Zoely®, follow the missed pills advice.

We are now going to have a look at the progestogen-only pill:

·      The POP has several independent modes of action, including thickening cervical mucus thereby preventing sperm penetration, delaying ovum transport, inhibiting ovulation, and providing an endometrium hostile to implantation.

·      It should be taken daily with no pill-free interval.

·      When used perfectly, the failure rate is 0.3% within the first year of use but in the real world, the failure rate can go up to 9%.

·      Any licensed progestogen-only pill (POP) may be used first line and we can prescribe 12 months' supply when initiating or continuing a POP. 

How should we start a progestogen-only pill except drospirenone?

·      In women with menstrual cycles:

o  We will start on days 1–5 and no additional precaution is required.

o  If no possibility of pregnancy and starting at any other time we will advise a barrier method for 2 days.

o  If there is risk of pregnancy and starting at any other time, we will:

▪       Recommend an immediate pregnancy test and a follow up test no sooner than 3 weeks after the last episode of unprotected sexual intercourse (UPSI).

▪       consider emergency contraception.

▪       Quick start the POP but delay for 5 days if ulipristal EC was given.

▪       advise a barrier method for 2 days.

▪       And This applies also to women who are amenorrhoeic and have had UPSI in the last 21 days. However,

·      In women who are amenorrhoeic and no UPSI in the last 21 days:

o  We will do a pregnancy test and

o  We will start the POP and advise a barrier method for 2 days

·      The POP can be started at any time after childbirth, including immediately after delivery regardless of breastfeeding. However:

o  If started up to day 21 postpartum no additional precaution is required but

o  After day 21 postpartum, we will ensure that the patient is not pregnant, then start the POP recommending a barrier method for 2 days 

·      In women post first- or second-trimester abortion:

o  The POP should ideally be started on the day or day after a first- or second-trimester abortion but otherwise management is no different to menstruating women.

·      If starting the POP after oral EC, we will:

o      Start the POP immediately if levonorgestrel was given or 5 days after taking ulipristal.

o      We will recommend a barrier method for 2 days. And we will

o      Advise the woman to do a pregnancy test no sooner than 3 weeks after the last episode of UPSI.

How should we switch to the progestogen-only pill (except drospirenone) from other methods of contraception?

·      If we are switching from combined oral contraceptive:

o  If we are starting on days 1–2 of the break then no additional precaution is required.

o  If we are starting on days 3–7 of the break or week 1 following the break and if there is no risk of pregnancy, then:

▪       We should advise a barrier method for 2 days.

o  If we are starting on days 3–7 of the break or week 1 following the break but unprotected sexual intercourse (UPSI) has occurred after in that time:

▪       We will restart or continue the COC until 7 consecutive pills are taken after the break then switch.

▪       No additional precautions are required.

▪       If COC cannot be continued, we will start the POP immediately and we will consider the need for emergency contraception (EC) and a pregnancy test as well as recommending a barrier for 2 days.

o  If we are starting on weeks 2–3 of COC use, no additional precaution is required providing the method has been used consistently and correctly.

·      If we are switching from a POP to another POP:

o  We will start the new POP at any time in the menstrual cycle.

▪       If switching to drospirenone, advise a barrier method for 7 days but 

▪       For all other POPs, no additional precaution is required.

o  If we are switching from drospirenone, to a different POP, the guidance is complex depending on when in the cycle the switch takes place. I have not included it here and I recommend that you look this up if considering this option. 

·      If we are switching from a progestogen-only injectable to a POP other than drosperinenone:

o  If it is 14 weeks or less since the last injection then no additional precaution is needed.

o  If it is more than 14 weeks since the last injection and no risk of pregnancy we will recommend a barrier method for 2 days.

o  If it is more than 14 weeks since the last injection and there is a risk of pregnancy then we will consider the need for EC and a pregnancy test.

·      The advice on how to switch from a progestogen-only implant and intrauterine contraception can be fairly complex depending on various factors and these patients may very well be managed by family planning clinics so I will not cover them here. But feel free to check the links in the episode description if you wish to know more.

The advice above does not include drospirenone. However, if we are giving drospirenone we need to be aware that:

·      It needs to be started on day 1 of the normal menstrual cycle so that no additional precaution is required.

·      Any barrier method advice needs to be for 7 days as opposed for 2 days for other POPs

What are the possible risks and adverse effects of progestogen-only pills?

·      Well, Menstrual irregularities are common.

·      Other possible risks and adverse effects of the POP include: 

o  Ectopic pregnancy (with the exception of desogestrel), but the absolute risk is lower than if not using contraception.

o  Breast tenderness (which is usually transient). 

o  Ovarian cysts (which may be persistent).

o  Depression and changes in mood and libido.

o  Panic attacks (with the desogestrel pill).

o  Headache and migraines.

o  Weight changes.

·      The Breast cancer risk cannot be completely excluded. Any increased risk is likely to be small and to reduce with time after stopping. 

·      In terms of Cardiovascular disease (CVD) risk, The POP is generally appropriate for women with cardiac disease and is useful as a bridging method while specialist advice is being sought about contraceptive options.  

Drug interactions of the progestogen-only pill (POP) include: 

·      Liver enzyme-inducing drugs (such as rifampicin and carbamazepine) can reduce the efficacy of POPs. Therefore, we will:

o      change to an alternative contraceptive method for as long as she is on these drugs and for 28 days after. 

o      If this is not possible and she is on short-term treatment (2 months or less), we will continue the POP but we will advise a barrier method while taking, and for 28 days after stopping, the liver enzyme-inducing drug. and

o      We will Consider emergency contraception (EC) if unprotected sexual intercourse has taken place while the efficacy of the POP may have been reduced.

o      Other examples of liver enzyme inducing drugs include:

▪       Antibiotics such as Rifampicin and Rifabutin.

▪       Antiepileptics

▪       Antiretrovirals:

▪       St John's Wort.

·      Griseofulvin may also reduce the contraceptive effect of POPs and therefore we will recommend an alternative

·      Lamotrigine may increase plasma levels of progestogen so we should monitor side effects.

·      POPs may reduce the ability of ulipristal to delay ovulation and therefore after ulipristal the patient should:

o      wait 5 days (at least 120 hours) before continuing or starting the POP, with a pregnancy test 21 days later to exclude pregnancy resulting from EC failure.

o      We should recommend additional contraception until the POP is started and for 48 hours after, that is, for a week after Ulipristal. 

If a woman is found to be pregnant whilst using the progestogen-only pill (POP) and she wishes to continue with the pregnancy, we will:

·      stop the POP.

·      We will Inform her that there is no evidence of harm if pregnancy occurs while using the POP. and

·      We will Be alert to the possibility of an ectopic pregnancy.

Let’s look at the Missed pill advice for the POP

·      A pill is missed if the patient is: .

o  12 hours or more late (that is, more than 36 hours since the last pill) if on the desogestrel pill

o  24 hours or more late (that is 48 hours or more since the last pill) if on the drospirenone pill or

o  More than 3 hours late (that is, more than 27 hours since taking the last pill) if on any other progestogen-only pills

·      If the patient has missed a pill, we will advise:

o  To take a pill as soon as possible. If more than one pill has been missed, only one should be taken.

o  To take the next pill at the normal time. This may mean taking two pills in 24 hours (the missed pill and the next one at the usual time).

o  To use a barrier for 7 days if taking drospirenone, or 2 days for all other POPs.

·      We will consider prescribing emergency contraception if unprotected sexual intercourse has taken place after the missed pill and within 48 hours of restarting the POP. For drospirenone, we will consider prescribing emergency contraception in wider circumstances and I recommend that you look up the details in this case if you need to.

Let’s now look at the information and advice that we should give in the event of vomiting or diarrhoea

·      If there is vomiting within 2 hours of pill taking, another pill should be taken as soon as possible.

o  If the subsequent pill is taken more than 3 hours late (or 12 hours late for a desogestrel pill or 24 hours late for drospirenone), we will advise the missed pill rules.

o  If vomiting continues or very severe watery diarrhoea develops, we will advise the missed pill rules (counting each day of vomiting and/or diarrhoea as a missed pill) and use a barrier method during the illness and for 48 hours afterwards.

How long should the progestogen-only pill be used for?

·      If a woman aged over 50 years with amenorrhoea wishes to stop contraception before the age of 55 years:

o  We will check FSH levels on two occasions, with an interval of 6 weeks between tests.

o  If both FSH levels are more than 30 IU/L, the progestogen-only pill (POP) can be discontinued after a further year.

o  If the FSH level is in the premenopausal range, we will continue the POP and recheck the FSH level after 1 year.

·      Once a woman reaches 55 years of age, contraception can be stopped even if she is still experiencing menstrual bleeding.

o  However, if a woman aged 55 years or over does not wish to stop a particular method, consider continuing the method provided individual benefits and risks are assessed and discussed with her. 

·      The POP can be used concurrently with hormone replacement therapy (HRT) to provide effective contraception, but it should not be relied on as the progestogen component of HRT.

In conclusion, the management of oral contraception requires a comprehensive approach and it can become complex.

Please keep in mind that this is only a summary and my interpretation of the guideline. 

We have come to the end of this episode. I hope that you have found it useful. Thank you for listening and good-bye  

My name is Fernando Florido and I am a General Practitioner in the United Kingdom. Welcome to the latest instalment in our monthly video series, "NICE News," where we discuss new and updated guidelines published by the National Institute for Health and Care Excellence (NICE), specifically as it relates to primary care.

In this video, I'll be focusing on the NICE guidance and advice published in June 2023. We'll be reviewing the latest recommendations that are relevant to primary care practitioners, with the goal of keeping you informed and up-to-date on the latest developments.  

By way of disclaimer, I am not giving medical advice; this video is intended for health care professionals, it is only my interpretation of the guidelines and you must use your clinical judgement.  

There is a YouTube version of this and other videos that you can access here: 

• The NICE GP YouTube Channel: https://www.youtube.com/channel/UClrwFDI15W5uH3uRGuzoovw

The Full NICE News bulleting for June 2023 can be found at:  

·      https://www.nice.org.uk/guidance/published?from=2023-06-01&to=2023-06-30&ndt=Guidance&ndt=Quality+standard

The links to the update guidance covered can be found here:

Depression in adults:

·      https://www.nice.org.uk/guidance/qs8

Dapagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction:

·      https://www.nice.org.uk/guidance/ta902

Atopic eczema in under 12s: diagnosis and management:

·      https://www.nice.org.uk/guidance/cg57

Decision aid to guide healthcare professional-patient discussions on sleeping pill prescriptions published:

·      https://www.nice.org.uk/news/article/decision-aid-to-guide-healthcare-professional-patient-discussions-on-sleeping-pill-prescriptions-published

·     One page summary for patients: https://www.nice.org.uk/guidance/ng215/resources/should-i-stop-my-benzodiazepine-or-zdrug-patient-decision-aid-summary-pdf-13072600333

Intro / outro music: Track: Halfway Through — Broke In Summer [Audio Library Release]   

• Music provided by Audio Library Plus  

• Watch: https://youtu.be/aBGk6aJM3IU 

• Free Download / Stream: https://alplus.io/halfway-through 

Transcript

Hello and welcome to another episode of NICE News. My name is Fernando Florido, a GP in the United Kingdom. Today, we'll be discussing the NICE Guidance and advice published in June 2023, specifically for Primary Care.

This month we are focusing on Depression, Dapagliflozin in chronic heart failure, Atopic eczema, and we will briefly touch on the prescribing of sleeping pills

Before we begin, I want to remind you that this episode is not medical advice. It is only my interpretation, and you must use your clinical judgement.

I'd like to remind you that there is a YouTube version of this episode which can be found in the episode description.

Now, with that said, let’s get straight into it.

The first clinical area refers to Depression in adults and the updated quality standards are mostly common sense, but the one that caught my eye was the advice that spells out what we instinctively knew, that when stopping antidepressants, the dose needs to be reduced in stages. We should agree with the patient the speed and duration of the withdrawal and offer follow-up appointments to check both for withdrawal symptoms and the return of depression, ensuring that any withdrawal symptoms have resolved or are tolerable before making the next dose reduction.

The next clinical area covers Dapagliflozin in heart failure. You may know that there is already guidance that recommends Dapagliflozin for chronic heart failure with reduced ejection fraction but this update refers to heart failure with preserved or mildly reduced ejection fraction.

Current treatment of heart failure with preserved ejection fraction is loop diuretics, which manage symptoms, but do not reduce hospitalisations.

However, Dapagliflozin in chronic heart failure with reduced ejection fraction reduces cardiovascular deaths and hospitalisations for heart failure.

The clinical experts noted that chronic heart failure with reduced and preserved ejection fractions should not necessarily be considered as 2 separate conditions, and that they exist on a continuum. And therefore, the committee concluded that when its preferred assumptions are incorporated, dapagliflozin is cost-effective and therefore, recommended also for chronic heart failure with preserved ejection fraction.

The next update is in the management of atopic eczema in under 12s and the main outcome is that we should now not offer emollient bath additives, because evidence has shown that, although not harmful, they are not clinically or cost effective.

Emollient creams continue to be vital in helping to manage eczema, but we need to be aware that there are warnings about fire hazards associated with build-up of emollient on clothing and bedding.

We should prescribe large quantities of leave-on emollients (up to 500 g weekly) and explain:

·      That leave-on emollients can be added to bath water

·      That they should use emollients or emollient soap substitutes instead of soap and

·      That children aged under 12 months should use emollients or emollient soap substitutes instead of shampoos and older children should use unperfumed shampoos

Finally, NICE has published a patient decision aid and a one-page summary, that provides clear and easy-to-use advice to support patients taking benzodiazepines or z-drugs to help them understand the benefits and risks of staying on their current dose, reducing their dose, or stopping the drugs altogether.  I have put links to this patient leaflet in the episode description.

We have come to the end of this episode. I hope that you have found it useful. Thank you for listening and good-bye

My name is Fernando Florido and I am a GP in the United Kingdom. In today’s episode I review the NICE guidance on inhalers, both for asthma and COPD. I have summarised the guidance from a Primary Care perspective and I have put the links to that guidance below.

By way of disclaimer, I am not giving medical advice; this video is intended for health care professionals, it is only my interpretation of the guidelines and you must use your clinical judgement.   

There is a YouTube version of this and other videos that you can access here: 

• The NICE GP YouTube Channel: 

https://www.youtube.com/channel/UClrwFDI15W5uH3uRGuzoovw  

The following NICE guidance can be found here:

·      Asthma Inhaled corticosteroids- Last revised in April 2022: https://cks.nice.org.uk/topics/asthma/prescribing-information/inhaled-corticosteroids/

·      Asthma: Beta2 agonists- Last revised in April 2022: https://cks.nice.org.uk/topics/asthma/prescribing-information/beta-2-agonists/

·      Chronic obstructive pulmonary disease: Inhaled corticosteroids- Last revised in June 2023: https://cks.nice.org.uk/topics/chronic-obstructive-pulmonary-disease/prescribing-information/inhaled-corticosteroids/

·      Chronic obstructive pulmonary disease: Muscarinic antagonists- Last revised in June 2023: https://cks.nice.org.uk/topics/chronic-obstructive-pulmonary-disease/prescribing-information/muscarinic-antagonists/

·      Chronic obstructive pulmonary disease: Beta-2 agonists- Last revised in June 2023: https://cks.nice.org.uk/topics/chronic-obstructive-pulmonary-disease/prescribing-information/beta-2-agonists/

·      Corticosteroids - inhaled: Scenario: Corticosteroids – inhaled- Last revised in May 2020: https://cks.nice.org.uk/topics/corticosteroids-inhaled/management/corticosteroids-inhaled/#choosing-a-delivery-system

·      Corticosteroids – inhaled- Last revised in May 2020: https://cks.nice.org.uk/topics/corticosteroids-inhaled/

·      Corticosteroids - inhaled: Which inhaled corticosteroids are available in the UK?- Last revised in May 2020: https://cks.nice.org.uk/topics/corticosteroids-inhaled/background-information/types-of-inhaled-corticosteroids/

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Transcript 

Hello everyone, and welcome! I'm Fernando Florido, a GP in the United Kingdom.

Today, we're going to talk about inhalers – those small but powerful things that are a lifeline for people with asthma and COPD. But in the world of inhalers, things can get quite complex. With a multitude of brand names and different devices, navigating this world can feel like getting lost in a maze.

We'll try to bring order to this labyrinth by reviewing the NICE guidance on inhalers, both for asthma and COPD. I have summarised the guidance from a Primary Care perspective and I have put the links to that guidance in the episode description.

But before we begin, let's address the elephant in the room. Memorising the vast array of brand names, combinations, and different devices is no easy task. Not only would it be an overwhelming challenge, but it would also consume valuable brainpower that would be better utilised in other areas of our lives.

So, here's my advice: it's absolutely okay to look up specific inhaler brands when you need to. In today's digital age, we can quickly find the information we need without wasting our mental energy on trying to remember everything. This frees up our minds to focus on what truly matters.

If you prefer a video format, there’s also a YouTube version of these episodes. The link is in the episode description.

Please note that this is my interpretation of the guidelines, not medical advice.

So, with that said, hit that subscribe button and let's dive in!

The video has four parts, inhaled corticosteroids, inhaled beta-agonists, inhaled antimuscarinic agents and combination inhalers. 

Let’s start with inhaled steroids both for asthma and COPD.

What should we consider when initiating inhaled corticosteroids?

We should avoid prescribing generic inhalers to ensure continuity of the device type in future. 

The various inhaled corticosteroids are similar in efficacy and adverse effect profile. However, we need to remember that:

Qvar and Kelhale products have extrafine beclomethasone particles and are twice as potent as other beclometasone inhalers. 

What delivery systems are available for inhaled corticosteroids?

First, we have Pressurized metered-dose inhalers (pMDIs) which use propellant and have an environmental impact.

We also have Spacer devices with pMDIs, which are the preferred option for children under 5

Then we have the Dry powder inhalers (DPIs) which do not use propellant but require enough inspiratory effort to breathe in the powder

We also have the Breath-actuated MDIs (BA-MDIs) which also require sufficient inspiratory effort to activate the device. 

Finally, Nebulizers given as an aerosol that can be inhaled through a mask or mouthpiece. A mouthpiece is preferable to avoid adverse effects caused by exposure to the skin and eyes. 

What contraindications and cautions are associated with inhaled corticosteroids?

There are no contraindications to the use of inhaled corticosteroids and they can be given during pregnancy and breastfeeding.

Cautions are untreated tuberculosis, fungal, bacterial, parasitic, or systemic viral infections, as well as ocular herpes simplex.

What are the effects of inhaled corticosteroids?

Well, they have potent anti-inflammatory activity both the immediate and late phases of asthma.

Inhaled corticosteroids available in the UK include beclometasone, budesonide, ciclesonide, fluticasone, and mometasone.

They are also available as combination inhalers containing long-acting beta-2 agonists.

In asthma, a long-acting bronchodilator should be given in combination with an ICS. In other words, a long-acting bronchodilator should not be normally given in isolation for asthma.

Conversely, in COPD, an ICS should be given in combination with a long-acting bronchodilator, having discussed the risk of adverse effects including an increased risk of pneumonia which may require hospitalization. In other words, an ICS should not be normally given in isolation for COPD.

Local adverse effects include:

Oral candidiasis, sore mouth, dysphonia, and hoarseness, especially in high doses as well as

Paradoxical bronchospasm.

Systemic adverse effects are rare but may occur if high doses are prescribed for prolonged periods.

We will issue a steroid treatment card to:

People using prolonged high doses.

People taking drugs that inhibit steroid metabolism such as antiretroviral HIV drugs

In children, height should be monitored regularly.

And we will use the lowest dose of inhaled corticosteroid (ICS) that maintains effective control of symptoms. 

Which inhaled corticosteroids are available in the UK?

If we want to give Beclometasone dipropionate we can prescribe one of the following brands:

Clenil Modulite MDI

Easyhaler beclometasone

Kelhale MDI

QVAR MDI

QVAR Autohaler

QVAR Easi-Breathe

Soprobec MDI and

Beclu MDI

But we need to be aware that kelhale and Qvar contain beclomethasone extrafine particles and are therefore more potent.

If we want to give budesonide we will prescribe one of the following brands:

Budelin Novolizer

Easyhaler Budesonide and

Pulmicort Turbohaler

If we want to give Ciclesonide we will prescribe: Alvesco MDI

If we want to give Fluticasone we will prescribe Flixotide either the Evohaler MDI or the Accuhaler

And If we want to give Mometasone we will prescribe: Asmanex Twisthaler

What dosing regimens should we consider?

NICE has issued the following guidance on ICS dosages:

A high dose is more than 800 micrograms budesonide or equivalent in adults and more than 400 mcg in children.

A moderate dose is between 400 micrograms and 800 micrograms budesonide or equivalent in adults and between 200mcg and 400 mcg in children

A low dose is 400 micrograms or less of budesonide or equivalent in adults or 200 mcg or less in children.

Examples of dose equivalence are as follows:

Budesonide 200mcg would be equivalent to 200mcg of mometasone and 200 mcg Beclomethasone, but only 100 mcg if we prescribe Beclomethasone extrafine particles.

Equally Budesonide 200mcg would be more or less equivalent to 160 mcg of Ciclesonide or 125 mcg of Fluticasone

Let’s now move on to the section on beta agonists.

By way of introduction, we will say that

Beta-2 agonists — act directly on beta-2 receptors, causing smooth muscle relaxation and dilatation of the airways.

Short-acting beta-2 agonists or SABAs, such as salbutamol and terbutaline, have a rapid onset of action, about 15 minutes and their effects last for up to 4 hours.

Long-acting beta-2 agonists (LABAs) have prolonged receptor occupancy and

Salmeterol and formoterol have a duration of action of 12 hours and

In asthma they should only be used with an ICS.

Indacaterol and olodaterol are once daily LABAs licensed for use in COPD in adults; they are not indicated for the relief of acute bronchospasm.

Vilanterol is available only in combination with fluticasone furoate or/and with the antimuscarinic umeclidinium.

(Cautions)

Beta-2 agonists should be used with caution in people with:

Hyperthyroidism as they may stimulate thyroid activity.

Cardiovascular disease (including hypertension) because of changes to blood pressure and heart rate and an increased risk of arrhythmias especially if there is susceptibility to QT-interval prolongation.

Hypokalaemia, as this may be caused by high doses of beta-2 agonists and

Convulsive disorders.

(Adverse effects)

Adverse effects of short-acting and long-acting beta-2 agonists are similar. They are usually dose related and include:

Nervous system disorders such as tremor, headache, dizziness and seizures.

Cardiac disorders such as palpitations, arrhythmias, peripheral vasodilation and myocardial ischaemia.

Psychiatric disorders such as anxiety, restlessness and insomnia.

Metabolic disorders such as:

Hypokalaemia and

Hyperglycaemia.

Respiratory disorders such as oropharyngeal irritation and paradoxical bronchospasm (which is rare).

Musculoskeletal disorders such as muscle cramps, and

Acute angle-closure glaucoma which has been reported in people using nebulized short-acting beta-2 agonists: using a mouthpiece rather than a mask is preferable to avoid this

We should advise people who are using terbutaline turbohaler to rinse their mouth after each use to minimize systemic absorption.

What drug interactions are important with beta-2 agonists?

Because of the hypokalaemia risk, we should monitor potassium levels with:

Digoxin and

Potassium-depleting drugs like corticosteroids, diuretics, and theophylline

Non-selective B-blocking drugs such as propranolol —and the manufacturer recommends avoid.

And Ketoconazole may increase plasma levels of salmeterol.

Which short-acting beta-2 agonists are available?

Salbutamol is available in the form of:

Airomir autohaler

Airomir MDI

Salamol Easibreathe

Salamol MDI

Ventolin evohaler

Easyhaler salbutamol

Salbulin novolizer

Terbutaline in the form of:

Bricanyl turbohaler              

Which long-acting beta-2 agonists are available?

As we have said before, we can use individual LABA inhalers for COPD.

We have Formoterol:

And Formoterol can be prescribed as:

Atimos modulate

Foradil DPI

Oxis turbohaler

Formoterol Easyhaler.

Then we have Salmeterol:

which can be prescribed as:

Neovent MDI

Serevent evohaler

Serevent accuhaler and

Soltel MDI.

Indacaterol

which can be prescribed as Onbrez Breezhaler

And Olodaterol:

which ca be prescribed as:

Striverdi Respimat

And then we have the combination inhalers, both for asthma and COPD. but we are going to look at them separately in the fourth section of this video.

We are now going to look at the inhaled antimuscarinic agents.

Muscarinic antagonists cause bronchodilation by blocking the bronchoconstrictor effect of acetylcholine on airway smooth muscle.

Ipratropium is a short-acting muscarinic antagonist (or SAMA)

The maximal effect is at 30–60 minutes and

the duration of action is 3–6 hours.

Long-acting muscarinic antagonists (or LAMAs) have a prolonged bronchodilator effect. Examples are:

Tiotropium and also

Aclidinium, glycopyrronium, and umeclidinium.

Which short-acting muscarinic antagonists are available for COPD?

Excluding the preparations for nebulisers

we only have Ipratropium MDI

Which long-acting muscarinic antagonists are available for COPD?

Tiotropium: can be prescribed as:

Spiriva Respimat®

Spiriva® inhalation powder

Acopair inhalation powder,

Tiogiva inhalation powder,

Braltus® inhalation powder,

Aclidinium can be prescribed as:

Eklira inhalation powder

Glycopyrronium can be prescribed as:

Seebri Breezhaler, inhalation powder

And Umeclidinium can be prescribed as:

Incruse Ellipta DPI

When should antimuscarinics be used with caution?

Antimuscarinics should be used with caution in:

Prostatic hyperplasia and bladder-outflow obstruction

Renal impairment

Angle-closure glaucoma especially with nebulizer

And Pregnancy or breastfeeding

Additionally, Tiotropium should be used with caution in people with cardiac arrhythmias, heart failure or myocardial infarction in the previous 6 months because there is an

Increased risk of all-cause mortality following the use of this product.

Lastly, Combination ipratropium with salbutamol is contraindicated in people with hypertrophic obstructive cardio- myopathy or tachyarrhythmia.

What are the adverse effects of antimuscarinics?

The adverse effects of antimuscarinics include:

Cardiac disorders such as arrhythmias and palpitations.

Respiratory disorders such as paradoxical bronchospasm, throat irritation, and cough.

Gastrointestinal disorders such as dry mouth, abnormal taste, nausea, vomiting, constipation and diarrhoea.

ENT disorders such as nasal congestion, dryness of nasal mucosa, and epistaxis.

Nervous system disorders such as headache and dizziness.

Urinary disorders such as bladder outflow obstruction and prostatic hyperplasia.

And Visual disorders including acute angle-closure glaucoma

What drug interactions are important with muscarinic antagonists?

Concurrent use of inhaled antimuscarinics with other antimuscarinic drugs is not recommended as the effects of concurrent use have not been studied.

We now move to look at combination inhalers and

There are three types of combination inhalers

Combination of an ICS with a LABA

which can be used in both asthma and COPD

Combination of three drugs, an ICS, a LAMA and a LABA for use in COPD

Combination of a LAMA and a LABA, that is, without an ICS, for use in COPD

So, What ICS and LABA combination inhalers are available?

We have the following combinations:

Beclometasone and formoterol both as pMDI and DPI: They include

Fostair pMDI

Fostair NEXThaler and

Luforbec pMDI

We need to be aware that Fostair and Luforbec contain extra fine beclomethasone and therefore it is more potent than traditional beclometasone CFC-free inhalers so their dose should be lower.

The combination of Budesonide and formoterol come only as DPI: in the form of

DuoResp Spiromax

Symbicort Turbohaler

Fobumix Easyhaler and

WockAIR DPI

Then we have Fluticasone and formoterol both as pMDI and DPI: in the form of

Flutiform MDI

Flutiform K-haler

The biggest group belong to the Fluticasone and salmeterol combination, both as pMDI and DPI: There are 15 different inhalers such as:

o  Avenor MDI

o  AirFluSal Forspiro 

o  AirFluSal pMDI 

o  Aloflute pMDI 

o  Campona Airmaster

o  Combisal pMDI 

o  Fixkoh Airmaster

o  Fusacomb Easyhaler 

o  Sereflo pMDI 

o  Sereflo Ciphaler

o  Seretide Accuhaler

o  Seretide Evohaler

o  Sirdupla pMDI

Stalpex DPI

Seffalair Spiromax

And on the other extreme, we have just one inhaler for the Fluticasone and vilanterol combination, which is a DPI: which is

Relvar Ellipta

Next question is What ICS, LABA and LAMA combination inhalers are available? And we have 3 groups:

First, we have the Beclomethasone, glycopyrronium and formoterol combination both as pMDI and DPI: and they are

Trimbow pMDI and

Trimbow NEXThaler

Then we have the combination of Budesonide, glycopyrronium and Formoterol as an pMDI: which is

Trixeo MDI

And as the third group, we have Fluticasone, umeclidinium and Vilanterol as a DPI in the form of

Trelegy Ellipta

Finally, What LABA and LAMA combination inhalers are available?

There are four:

Glycopyrronium with formoterol as an MDI in the form of

Bevespi Aerosphere

Glycopyrronium and indacaterol as a DPI in the form of

Ultibro Breezhaler

Then aclidinium with Formoterol as a DPI as

Duaklir

And lastly, tiotropium and olodaterol as an MDI in the form of

Spiolto Respimat

I have checked the NICE guidance and the BNF in order to make this list as exhaustive as possible.

In conclusion, what is important is to know the effect and indications of the different inhaled drugs. Remembering all the different inhaler brands and combinations is tough so it's okay to look them up when you need to saving our brainpower for more important things.

Please keep in mind that this is only a summary and my interpretation of the guidance.

We have come to the end of this episode. I hope that you have found it useful. Thank you for listening and good-bye