AstraZeneca releases detailed results of P3 trial of SGLT2 inhibitor

Lee Han-soo  Published 2019.09.24  18:08  Updated 2019.09.24 18:08


AstraZeneca announced detailed results of the landmark phase 3 DAPA-HF trial that showed Forxiga reduced both the incidence of cardiovascular death and the worsening of heart failure.

AstraZeneca's SGLT-2 inhibitor Forxiga

DAPA-HF is the first trial outcome with an SGLT2 inhibitor investigating the treatment of heart failure in patients with reduced ejection fraction (HFrEF), with and without type-2 diabetes (T2D). Forxiga is currently approved to treat patients with T2D.

Topline results showed DAPA-HF met the primary endpoint. The detailed results of the trial presented at the ESC Congress 2019 showed Forxiga reduced the composite of cardiovascular (CV) death or worsening of heart failure by 26 percent and showed a reduction in each of the individual components of the composite endpoint.

“Forxiga is well established in the treatment of type-2 diabetes, and these exciting new findings offer clinically meaningful insights into the potential of the medicine to reduce the burden of heart failure in patients with and without type-2 diabetes,” said Mene Pangalos, executive vice president of AstraZeneca's Biopharmaceuticals R&D Division.

The company is proud to contribute to the scientific body of evidence during the ESC Congress 2019, Pangalos added.

John McMurray, a professor at the University of Glasgow’s Cardiovascular Research Centre, also said, “We are very pleased that Forxiga was so effective in our trial. It did all the things we would like any drug to do in heart failure, which is to improve symptoms, reduce hospital admissions, and increase survival.”

Even better, Forxiga was as effective in heart failure patients without diabetes as in those with diabetes, McMurray added.

In analyzing each of the components of the primary composite endpoint, there was a 30 percent decrease in the risk of experiencing a first episode of worsening heart failure and an 18 percent decrease in the risk of dying from cardiovascular causes. The effect of Forxiga on the primary composite endpoint was generally consistent across the key subgroups examined.

The trial results also showed a significant improvement in patient-reported outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score and a nominally significant reduction in all-cause mortality by 17 percent (7.9 percent vs. 9.5 patients with an event per 100 patient-years) in favor of Forxiga.

The safety profile of Forxiga in the DAPA-HF trial was consistent with the well-established safety profile of the medicine. The proportion of patients with volume depletion (7.5 percent vs. 6.8 percent) and renal adverse events (6.5 percent vs. 7.2 percent), which are common concerns when treating heart failure, were comparable to placebo.

Major hypoglycemic events (0.2 vs. 0.2 percent) were rare in both treatment groups.

Researchers are also studying Forxiga in patients with heart failure with preserved ejection fraction in the DELIVER and DETERMINE trials.

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