On 8 November at this year’s American Heart Association conference, during a clinical session on the topic of ‘Heart Failure Trials on Parade’, Professor Juan Badimon presented results of the SOTA-P-CARDIA trial. The SOTA-P-CARDIA trial represents a significant advancement in heart failure therapeutics, demonstrating the first clinical evidence that Inpefa (sotagliflozin) provides substantial benefits for heart failure with preserved ejection fraction (HFpEF) patients without diabetes.
SOTA-P-CARDIA, a prospective, randomised, double-blind, placebo-controlled study evaluated the effects of sotagliflozin in nondiabetic HFpEF patients. The SOTA-P-CARDIA trial represents a paradigm-shifting study that extends the therapeutic utility of dual sodium-glucose cotransporter (SGLT) 1/2 inhibition beyond its established role in diabetic populations. By demonstrating significant benefits in nondiabetic HFpEF patients, this research addresses a critical knowledge gap and challenges the historical assumption that SGLT inhibitors primarily benefit patients through glycemic mechanisms. The trial’s use of cardiac magnetic resonance imaging for the primary endpoint provides robust evidence quality. The reduction in left ventricular (LV) mass is significant, as LV hypertrophy and remodeling constitute fundamental pathophysiological drivers of HFpEF progression. This structural improvement, combined with enhanced diastolic function, suggests that sotagliflozin may exert disease-modifying effects rather than just providing symptomatic relief. In addition, improvements across multiple validated secondary endpoints – functional capacity, quality of life, and cardiac structure/function – strengthen confidence in the findings and suggest clinically meaningful benefits that extend beyond isolated surrogate markers.
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The presentation highlighted limitations of the trial – small sample size and short duration, hence the findings require validation in larger, longer-duration studies.
Sotagliflozin’s unique positioning as a dual inhibitor, combined with the new HFpEF nondiabetic data, provides differentiation opportunities that could drive increased adoption, particularly if supported by clinical guideline incorporation of the SOTA-P-CARDIA findings. A key opinion leader interviewed by leading data and analytics company GlobalData stated: “If the guidelines say, an SGLT2 is appropriate here, then you know, it won’t mean that every SGLT2 will be covered. So guidelines are very important in terms of our decision-making and access for drugs.”
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