AstraZeneca has unveiled new data showing a statistically-significant reduction in hospitalisation for heart failure or cardiovascular (CV) death in a broad population of patients with type II diabetes taking Farxiga.
The Phase III DECLARE-TIMI 58 trial assessed CV outcomes of Farxiga (dapagliflozin) versus placebo over a period of up to five years, across 33 countries and in more than 17,000 adults type II diabetes who have multiple CV risk factors or established CV disease.
In the trial, Farxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or CV death, one of the two primary efficacy endpoints.
Also, fewer major adverse cardiovascular events (MACE) were observed with Farxiga for the other primary efficacy endpoint, but this did not reach statistical significance, AstraZeneca said.
“The results from this landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalisations that result in a considerable societal and economic burden,” said Elisabeth Björk, vice president, head of Cardiovascular, Renal and Metabolism, Global Medicines Development.
“The DECLARE-TIMI 58 results offer compelling evidence that dapagliflozin helps to address an important medical need among a diverse group of patients with type-2 diabetes by reducing the composite of hospitalisation for heart failure or CV death, with a safety profile supportive of broad use,” added Dr Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, a senior investigator with the Thrombolysis in Myocardial Infarction (TIMI) study group and co-principal investigator of the trial.
Detailed trial results will be presented in November at the American Heart Association Scientific Sessions 2018 in Chicago, AZ said.