Diabetes Drug Has Positive Phase 3 Results in Large Study, Cutting Heart Risks

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By : Suvarna Sheth

Astra Zeneca’s diabetes drug, Farxiga met primary endpoints in a large clinical study, showing a significant reduction in hospitalization rates for heart failure or CV death in a broad population of patients.

The company also reported fewer adverse events – such as heart attacks and stroke although the difference did not reach statistical significance.

The trial, known as Declare, studied the CV outcomes Farxiga of vs. placebo over a period of up to five years, across 33 countries and in more than 17,000 adults with Type 2 diabetes who have multiple CV risk factors or established CV disease.

Patients with diabetes are at increased risk for heart problems, making the CV profile for a given drug an important consideration for doctors and patients.

In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with Farxiga 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs. 6.9% vs. 1.5%), nasopharyngitis (6.6% vs. 6.3% vs. 6.2%), and urinary tract infections (5.7% vs. 4.3% vs. 3.7%), according to a company statement.

“Farxiga achieved a statistically-significant and clinically-important reduction in hospitalization for heart failure or CV death in a broad range of patients with Type 2 diabetes and cardiovascular risk,” said Elisabeth Björk, vice president, head of cardiovascular, renal and metabolism, global medicines development at AstraZeneca in a press release.

“The results from this landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalizations that result in a considerable societal and economic burden,” she added.

The Declare trial is an AstraZeneca-sponsored, randomized, double-blinded, placebo-controlled, multicenter trial designed to evaluate the effect of FARXIGA compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease.

The trial was independently run in collaboration with academic investigators from the TIMI study group (Boston, USA) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).

Full results of the Declare trial will be presented on Nov. 10 at the annual meeting of the American Heart Association.