Study shows AZ's Farxiga diabetes drug cuts heart risks


AstraZeneca’s Farxiga has become the latest type 2 diabetes drug to show it can reduce cardiovascular risk in a clinical trial.

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) was the first diabetes drug to show an improvement in cardio outcomes in high-risk patients three years ago in the landmark EMPA-REG study.

The trial was the result of an FDA requirement for all diabetes drugs to be tested for cardiovascular safety, but pharma companies decided to go one better and produce drugs that improve cardiac outcomes.

Since then other diabetes drugs have also been shown to improve cardio outcomes, such as Novo Nordisk’s Victoza (liraglutide) in the LEADER study.

AstraZeneca said in the phase III DECLARE-TIMI 58 trial, Farxiga (dapagliflozin) met its primary safety endpoint, showing that compared with placebo it did not worsen the risk of cardiovascular events.

Farxiga went one better and achieved statistically significant reduction in the composite endpoint of hospitalisations for heart failure, or cardiovascular death, one of the two primary efficacy endpoints.

Overall there were fewer MACE events observed, and although there were fewer stroke events observed with Farxiga, the other efficacy endpoint, this did not reach statistical significance.

The randomised, double-blinded, placebo-controlled, multicentre trial was designed to evaluate the effect of Farxiga compared with placebo on CV outcomes in adults with type 2 diabetes at risk of CV events, including patients with multiple CV risk factors or established CV disease.

DECLARE included more than 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, USA) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).

The results will be a boost to AZ in the highly competitive market for drugs that help diabetes patients reduce their blood sugar.

Farxiga this year broke through the billion dollar annual sales barrier, after AZ is looking to a new generation of drugs to replace sales lost when blockbusters such as cholesterol drug Crestor (rosuvastatin calcium) went off patent.

The findings could help to convince doctors to prescribe Farxiga, by claiming the drug will help save patients’ lives, as well as wider costs to the healthcare system caused by cardiovascular admissions.

Elisabeth Björk, AZ’s vice president and head of cardiovascular, renal and metabolism (CVRM), global medicines development said: “Farxiga has achieved a statistically-significant and clinically-important reduction in hospitalisation for heart failure or CV death in a broad range of patients with type-2 diabetes and cardiovascular risk.

“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.”