Phase 3 CV outcomes study with pemafibrate stopped early
The PROMINENT study, which investigated whether pemafibrate could reduce CV outcomes by reducing triglycerides in patients with T2DM, will be stopped early. This decision follows recommendations of the Data Safety Monitoring Board (DSMB). The DSMB reviewed the results of a planned interim analysis and concluded that it was unlikely that the primary endpoint would be met. There were no notable safety concerns.
The phase 3 PROMINENT study investigated the effects of pemafibrate on risk of CV events in high-risk patients with T2DM, mild-to-moderate hypertriglyceridemia and low levels of HDL-c treated with statins. The primary endpoint is a composite of nonfatal MI, nonfatal ischemic stroke, coronary revascularization and CV death.
Investigations with pemafibrate will be continued in new therapeutic areas, including nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), as the analysis of the PROMINENT results showed encouraging data in these areas.
Source: Press release Kowa Research Institute, 8 April, 2022