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SodiumGlucose Cotransporter 2 Inhibitor With and Without an Aldosterone Antagonist for Heart Failure With Preserved Ejection Fraction The SOGALDIPEF Trial summary
PACULit examines the SOGALDI-PEF trial, the first randomized crossover study comparing dapagliflozin alone versus dapagliflozin plus spironolactone in heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF). The episode discusses the rationale for combining an SGLT2 inhibitor with a mineralocorticoid receptor antagonist, the primary NT-proBNP endpoint as a surrogate for cardiac stress, and key results showing an approximate 11% relative reduction in NT-proBNP with combination therapy, along with reductions in systolic blood pressure and urinary albumin-to-creatinine ratio, but with greater eGFR decline and higher potassium-related safety concerns. Design features (108 patients, 12-week treatment periods per arm, open-label with blinded endpoints) and limitations (short duration, small sample, lack of hard outcomes) are explored, as are clinical implications for balancing potential efficacy with risks of hyperkalemia and renal dysfunction. The episode emphasizes the need for careful patient selection, monitoring, and larger, longer trials to confirm hard outcomes in HFpEF/HFmrEF.
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By Pharmacy & Acute Care UniversityPACULit examines the SOGALDI-PEF trial, the first randomized crossover study comparing dapagliflozin alone versus dapagliflozin plus spironolactone in heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF). The episode discusses the rationale for combining an SGLT2 inhibitor with a mineralocorticoid receptor antagonist, the primary NT-proBNP endpoint as a surrogate for cardiac stress, and key results showing an approximate 11% relative reduction in NT-proBNP with combination therapy, along with reductions in systolic blood pressure and urinary albumin-to-creatinine ratio, but with greater eGFR decline and higher potassium-related safety concerns. Design features (108 patients, 12-week treatment periods per arm, open-label with blinded endpoints) and limitations (short duration, small sample, lack of hard outcomes) are explored, as are clinical implications for balancing potential efficacy with risks of hyperkalemia and renal dysfunction. The episode emphasizes the need for careful patient selection, monitoring, and larger, longer trials to confirm hard outcomes in HFpEF/HFmrEF.