Novel drug pemafibrate neutral on reducing CV events among patients with diabetes with hypertriglyceridemia

PPARα agonists like fibrates are a class of drugs that reduce the level of triglycerides in the bloodstream through several mechanisms. Pemafibrate, developed by Kowa Company, Ltd as a selective PPARα modulator (SPPARMα), is licensed for use in Japan and some other Asian countries; conventional fibrate drugs such as fenofibrate are approved for use around the world including the U.S.

The clinical trial, known as PROMINENT and sponsored by the Kowa Research Institute, Inc., included 10,497 patients who had type 2 diabetes, increased levels of triglycerides, and low levels of HDL-cholesterol-a group that had shown promising results in fibrate trials performed a decade ago. However, the PROMINENT trial primary endpoint of heart attack, stroke, need for coronary bypass or angioplasty, or cardiovascular death occurred in 572 participants randomly assigned to pemafibrate and 560 assigned to placebo, resulting in no statistical difference between groups. Pemafibrate, however, was generally well-tolerated and appeared to reduce rates of non-alcoholic fatty liver disease (NAFLD), an important condition among individuals with diabetes and obesity.

Reference:

Aruna Das Pradhan, Robert J. Glynn, Jean-Charles Fruchart, Jean G. MacFadyen, Elaine S. Zaharris, Brendan M. Everett, Stuart E. Campbell, Ryu Oshima, R.Ph., Pierre Amarenco, Dirk J. Blom, Eliot A. Brinton, Robert H. Eckel, DOI: 10.1056/NEJMoa2210645