Dapagliflozin meets endpoint in top-line DECLARE results, AstraZeneca says

AstraZeneca announced top-line results of its phase III DECLARE-TIMI 58 cardiovascular outcomes trial for dapagliflozin (Farxiga). The 5-year international trial evaluated the cardiovascular outcomes of dapagliflozin compared with placebo in more than 17,000 adults with type 2 diabetes at high cardiovascular risk or established disease.

DECLARE met its primary safety endpoint of noninferiority for major adverse cardiovascular events for dabigatran the company said. Specifically, it achieved a statistically significant reduction in the composite endpoint of hospitalization for heart failure or cardiovascular death.

Dapagliflozin, approved in 2014, is a sodium-glucose  cotransporter  2  (SGLT2)  inhibitor  indicated as  an  adjunct  to  diet  and  exercise  to  improve  glycemic  control  in  adults  with type 2 diabetes.

Full results of DECLARE will be presented on November 10 at the American Heart Association annual meeting, according to the AstraZeneca release.