Merck and Pfizer Report Results of Steglatro (ertugliflozin) in P-III VERTIS CV Study for Type 2 Diabetes and Atherosclerotic Cardiovascular Disease

Shots:

• The P-III VETRIS CV study evaluates the Steglatro (5mg, 15mg) vs PBO in addition to SOC as background treatment in 8,200+ patients with T2D and atherosclerotic CV disease across 531 centers in 34 countries. The study will satisfy the US FDA’s guidance on demonstration of CV safety for Steglatro in the pre-approval and post-approval time periods
• Results: Met its 1EPs of non-inferiority on MACE (11.9% vs 11.9%); 2EPs were not met which include time to the first occurrence of the composite of CV death or HHF (8.1% vs 9.1%), time to CV death alone (6.2% vs 6.7%) and time to the first occurrence of the composite of renal death, dialysis/transplant or doubling of serum creatinine (3.2% vs 3.9%)
• Steglatro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D Mellitus and is not recommended in patients with T1D Mellitus or for the treatment of diabetic ketoacidosis

Click here to read full press release/ article | Ref: Businesswire | Image: Pharmaworld