Preliminary REDUCE-IT Results: Vascepa Lowers MACE Risk, Is Well Tolerated

Topline results from the REDUCE-IT trial, currently exploring the potential cardiac benefits of icosapent ethyl ( Vascepa, Amarin) for use in statin-controlled patients with elevated triglycerides, has met its primary efficacy and safety endpoints, according to a press release from its manufacturer, Amarin. 

The researchers for the REDUCE-IT study enrolled patients with LDL-C levels between 41 and 100 mg/dL who were taking statins and presented with cardiovascular risk factors such as elevated triglycerides (between 150 and 499 mg/dL) and either established cardiovascular disease or diabetes mellitus and at least one other cardiovascular risk factor. Patients were randomized 1:1 and assigned to receive a stable statin plus Vascepa 4 g/day or stable statin plus placebo. The study included a total of 8,179 patients. The primary study endpoint was a composite of major adverse cardiac events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. 

According to the preliminary study results reported by the manufacturer, the study met its primary efficacy endpoint, with an approximately 25% reduction in relative risk for MACE reported for the intent-to-treat population (P<0.001). Efficacy was demonstrated across the secondary endpoints as well. In addition, the study also met its primary safety endpoint; the drug was well-tolerated, with similar adverse event rates reported between study groups.      

“I look forward to the publication of these detailed REDUCE-IT results in a major peer-reviewed journal and to presenting them at the AHA in November,” stated Deepak L. Bhatt, MD, MPH, Professor of Medicine at Harvard Medical School, Executive Director of Interventional Cardiovascular Programs at the Heart and Vascular Center at Brigham and Women’s Hospital, and the Principal Investigator and Steering Committee Chair for REDUCE-IT, said in a press release. 

The study has been accepted for presentation as a late-breaking clinical trial, and complete results will be reported at the American Heart Association 2018 Scientific Sessions in Chicago on November 10.  

Source: Amarin Press Release