DAPA-HF Top-Line Results: Dapagliflozin Hits Primary Outcome

Patrice Wendling

August 20, 2019

A phase 3 randomized trial of the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga, AstraZeneca) for chronic heart failure has met its primary composite outcome with a "statistically significant" and "clinically meaningful" reduction in cardiovascular death or worsening heart failure, the sponsoring company announced today.

AstraZeneca released the top-line results from the Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure (DAPA-HF) trial in advance of a more comprehensive report. The European Society of Cardiology subsequently announced the study will be presented in a hotline session that has been added to next week's ESC Congress in Paris.

DAPA-HF is the first heart failure outcomes trial with an SGLT2 inhibitor in adults with heart failure with reduced ejection fraction (HFrEF), including those with and without diabetes, on top of standard care, the company notes.

The trial enrolled 4744 patients with symptomatic HFrEF (NYHA class II-IV) and randomly assigned them to once daily dapagliflozin 10 mg or 5 mg or matching placebo. People with type 1 diabetes mellitus or those with severe renal disease were excluded.

The primary outcome consisted of time to the first occurrence of cardiovascular death or hospitalization for heart failure or an urgent heart failure visit from randomization up to approximately 3 years.

Dapagliflozin is not recommended for patients with type 1 diabetes or diabetic ketoacidosis but is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Safety outcomes in the preliminary DAPA-HF analysis were "consistent with the well-established safety profile of the medicine," the company states.

A large, real-world diabetes study reported last year that SGLT2 inhibitors, including dapagliflozin, were associated with as much as a twofold increase in the risks of lower limb amputations and diabetic ketoacidosis compared with glucagon-like peptide 1 (GLP-1) receptor agonists.

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