REDUCE-IT trial of Vascepa meets primary endpoint in elevated triglycerides patients.- Amarin Corp.

Amarin Corp has announced topline results from the Vascepa (icosapent ethyl) cardiovascular outcomes trial, REDUCE-IT, a global study of 8,179 statin-treated adults with elevated CV risk. REDUCE-IT met its primary endpoint demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance (p<0.001), in major adverse cv events in the intent-to-treat patient population with use of vascepa 4 grams day as compared to placebo. patients enrolled in reduce-it had ldl-c between 41-100 mg dl (median baseline ldl-c 75 mg dl) controlled by statin therapy and various cv risk factors including persistent elevated triglycerides ("tgs") between 150-499 mg dl (median baseline 216 mg dl) and either established cv disease (secondary prevention cohort) or diabetes mellitus and at least one other cv risk factor (primary prevention cohort).>

Key topline results include efficacy data which shows an approximately 25% relative risk reduction, demonstrated to a high degree of statistical significance, in the primary endpoint composite of the first occurrence of MACE, including CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. This result was supported by robust demonstrations of efficacy across multiple secondary endpoints. In terms of safety, Vascepa was well tolerated with a safety profile consistent with clinical experience associated with omega-3 fatty acids and current FDA-approved labeling.

The proportions of patients experiencing adverse events and serious adverse events in REDUCE-IT were similar between the active and the placebo treatment groups. Median follow-up time in REDUCE-IT was 4.9 years. Amarin will share the REDUCE-IT data in greater detail at the 2018 Scientific Sessions of the American Heart Association