New SGLT2 inhibitor meets primary safety and HF hospitalization/CV death efficacy endpoint

News - Sep. 24, 2018

Positive results have been announced from the Phase III DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for dapagliflozin, the broadest SGLT2 inhibitor CVOT conducted to date. The trial evaluated the CV outcomes of dapagliflozin vs. placebo over a period of up to five years, across 33 countries and in more than 17,000 adults with type-2 diabetes (T2D) who have multiple CV risk factors or established CV disease.

In the DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 trial, dapagliflozin met its primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE). Dapagliflozin achieved a statistically-significant reduction in the composite endpoint of hospitalization for heart failure (hHF) or CV death, one of the two primary efficacy endpoints. Additionally, fewer MACE events were observed with dapagliflozin for the other primary efficacy endpoint of CV death, myocardial infarction or ischemic stroke, however, this did not reach statistical significance. Data from DECLARE-TIMI 58 confirmed the well-established safety profile of dapagliflozin.

Dapagliflozin is a first-in-class, oral, once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) indicated as both monotherapy and as part of combination therapy to improve glycemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise in adults with T2D. Dapagliflozin is not indicated to reduce the risk of CV events, CV death or hHF.

The DECLARE-TIMI 58 trial was independently run in collaboration with academic investigators from the TIMI study group (Boston, MA, USA) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).

Detailed trial results will be presented on 10 November at the American Heart Association Scientific Sessions 2018 in Chicago, IL, USA.

Source: press release AstraZeneca, September 24, 2018

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