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Merck and Pfizer’s SGLT2 Inhibitor STEGLATROTM (ertugliflozin) Meets Primary Endpoint in VERTIS CV Trial for Patients with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease

Published: 2020-06-16 17:15:00 ET
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Results Presented at the American Diabetes Association’s Virtual 80th Scientific Sessions

KENILWORTH, N.J. & NEW YORK--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced the presentation of results from the Phase 3 VERTIS CV cardiovascular (CV) outcomes trial that evaluated STEGLATRO (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, versus placebo, added to background standard of care treatment, in more than 8,200 patients with type 2 diabetes and atherosclerotic CV disease across 531 centers in 34 countries. The study met the primary endpoint of non-inferiority on major adverse CV events (MACE), which is composed of a composite of CV death, nonfatal myocardial infarction or nonfatal stroke, compared to placebo.

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“The VERTIS CV results add to the growing body of evidence regarding the clinical profile of ertugliflozin, including its safety in patients with a history of cardiovascular disease,” said Dr. Christopher P. Cannon, cardiologist at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, the study’s lead author. “Although not a part of the hierarchical testing sequence, the results indicated the potential of ertugliflozin to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease.”

Overall, the primary MACE outcome was reported in 11.9% (n=653) of patients treated with STEGLATRO (5 mg and 15 mg doses), compared with 11.9% (n=327) of patients treated with placebo (HR=0.97; 95.6% CI [0.85-1.11]; p