Amarin announced topline results from the Vascepa 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, in major adverse CV events in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo, Amarin said in a statement. Patients enrolled in REDUCE-IT had LDL-C between 41-100 mg/dL controlled by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 150-499 mg/dL and either established cardiovascular disease or diabetes mellitus and at least one other CV risk factor. Key topline results include 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 cardiovascular 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, the company said. It added that 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 placebo treatment groups. Median follow-up time in REDUCE-IT was 4.9 years. Amarin said it is “eager to share REDUCE-IT data in greater detail with both the medical community and regulatory authorities.” REDUCE-IT results have been accepted for presentation at the 2018 Scientific Sessions of the American Heart Association on November 10, 2018 in Chicago, Illinois. “We are delighted with these topline study results,” said John Thero, president and CEO of Amarin. “Given Vascepa is affordably priced, orally administered and has a favorable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT.” It notes, “As previously described, given the successful topline results of REDUCE-IT, Amarin is in the process of increasing the number of company sales representatives promoting Vascepa to over 400 people in the United States.” Shares of Amarin in premarket trading are up 151%, or $4.51, to $7.50.