MSD/Pfizer's diabetes drug Steglatro hits goal in CV outcomes trial

MSD and Pfizer have unveiled data from the Phase III VERTIS CV cardiovascular (CV) outcomes trial which add further evidence on the safety of their diabetes drug Steglatro (ertugliflozin).

Steglatro (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, was pitted against placebo, added to background standard of care treatment, in more than 8,200 patients with type 2 diabetes and atherosclerotic CV disease across 531 centres in 34 countries.

The study met the primary endpoint showing the drug to be non-inferior to placebo on major adverse CV events (MACE) – a composite of CV death, nonfatal myocardial infarction or nonfatal stroke – compared to placebo.

Overall, the primary MACE outcome was reported in 11.9% (n=653) of patients treated with Steglatro (5mg and 15mg doses), compared with 11.9% (n=327) of patients treated with placebo.

Key secondary endpoints of superiority for the drug versus placebo were not met. These included: time to the first occurrence of the composite of CV death or hospitalisation for heart failure (HHF), time to CV death alone and time to the first occurrence of the composite of renal death, dialysis/transplant or doubling of serum creatinine.

However, the pre-specified endpoint of HHF, while not a part of the hierarchical testing sequence, showed a 30% reduction in the risk of HHF for Steglatro versus placebo (2.5% vs. 3.6%, respectively).

"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," noted 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 hospitalisation for heart failure in patients with type 2 diabetes and established cardiovascular disease."