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August 20, 2019

AstraZeneca's Farxiga Meets Primary Endpoint in DAPA-HF Trial

August 20, 2019—AstraZeneca announced the results from its landmark phase 3 DAPA-HF trial, showing that the company's Farxiga (dapagliflozin, a sodium-glucose cotransporter 2 [SGLT2] inhibitor) met the primary composite endpoint with a statistically significant and clinically meaningful reduction of cardiovascular death or worsening heart failure (defined as hospitalization or urgent heart failure visit) compared with placebo. The full DAPA-HF trial results will be submitted for presentation at a forthcoming medical meeting.

The trial studied patients with chronic heart failure and reduced ejection fraction (HFrEF) who were on standard-of-care treatment, including those with and without type 2 diabetes. The safety profile of Farxiga in the DAPA-HF trial was consistent with the established safety profile of the medicine, advised the company.

DAPA-HF is a heart failure outcomes trial that investigated the Farxiga SGLT2 inhibitor to treat adults with HFrEF in addition to the standard of care (including medicines such as angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, ß-blockers, mineralocorticoid-receptor antagonists, and neprilysin inhibitors) who were New York Heart Association class II to IV, with and without type 2 diabetes.

This international, multicenter, parallel-group, randomized, double-blind trial in patients with HFrEF (left ventricular ejection fraction ≤ 40%) with and without type 2 diabetes was designed to evaluate the effect of Farxiga 10 mg, compared with a placebo, when given once daily in addition to standard of care. The primary composite outcome was time to a worsening heart failure event (hospitalization or equivalent event) or cardiovascular death. Farxiga is not indicated to reduce the risk of heart failure or cardiovascular death, noted AstraZeneca.

John McMurray, MD, commented in the company's announcement, “The benefits of dapagliflozin in DAPA-HF are very impressive, with a substantial reduction in the primary composite outcome of cardiovascular death or hospital admission. We hope these exciting new findings will ultimately help reduce the terrible burden of disease caused by heart failure and help improve outcomes for our patients.” Dr. McMurray is with the University of Glasgow, Cardiovascular Research Center, Institute of Cardiovascular and Medical Sciences, in Glasgow, United Kingdom.

AstraZeneca has developed the DapaCare clinical program to explore the cardiovascular and renal profile of Farxiga in patients with and without type 2 diabetes. The clinical program will enroll approximately 30,000 patients in randomized clinical trials and is supported by a multinational real-world evidence study. DapaCare will generate data across a spectrum of people with established cardiovascular disease, cardiovascular risk factors, and varying stages of renal disease, both with and without type 2 diabetes. Farxiga is also being developed for patients with heart failure with preserved ejection failure (HFpEF) in the DELIVER trial and with HFrEF and HFpEF in the DETERMINE trial, in addition to chronic kidney disease in the DAPA-CKD trial.

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