Dapagliflozin Achieves Phase III Clinical Endpoint Across All Heart Failure Patient Types Regardless of Ejection Fraction

Today, AstraZeneca announced that its SGLT2 inhibitor dapagliflozin (English trade name: Farxiga) achieved the primary endpoint in a Phase 3 clinical trial involving patients with mildly reduced or preserved ejection fraction heart failure, providing a statistically significant and clinically meaningful improvement in the risk of cardiovascular death or heart failure worsening. The press release noted that, combined with previous clinical trials conducted in patients with reduced ejection fraction, these results demonstrate that regardless of ejection fraction, dapagliflozin will benefit heart failure patients.

Heart failure is a chronic condition that progressively worsens over time, affecting the lives of nearly 64 million people worldwide. Based on left ventricular ejection fraction (LVEF), it can be divided into several major types: heart failure with reduced ejection fraction (HFrEF, LVEF<40%), heart failure with mildly reduced ejection fraction (HFmrEF, LVEF 41~49%), and heart failure with preserved ejection fraction (HFpEF, LVEF>50%). Nearly half of heart failure patients fall into the categories of HFmrEF and HFpEF, for whom treatment options are limited.

Dapagliflozin is a "first-in-class" oral SGLT2 inhibitor. It has been approved by the FDA, in conjunction with diet and exercise, to improve glycemic control in patients with type 2 diabetes, and can also reduce their body weight and blood pressure. It has also received FDA approval for the treatment of heart failure patients with reduced ejection fraction, as well as patients with chronic kidney disease.

This randomized, double-blind, placebo-controlled Phase 3 clinical trial, DELIVER, was conducted in heart failure patients with LVEF over 40%, with a total of 6,263 patients randomized. Specific data from the trial will be disclosed at upcoming medical conferences.

Mene Pangalos, Executive Vice President of Biopharmaceuticals R&D at AstraZeneca, said: "The breakthrough results today, combined with previous clinical trial results, demonstrate the effectiveness of dapagliflozin in treating heart failure regardless of ejection fraction."

References:

[1] Farxiga met primary endpoint in DELIVER Phase III trial, reducing risk of cardiovascular death or worsening heart failure in patients with preserved ejection fraction. Retrieved May 5, 2022, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/farxiga-hfpef-phase-iii-trial-met-primary-endpoint.html

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