Top-line results from the closely watched are out, and they show that Amarin's proprietary fish-oil drug Vascepa significantly reduced major cardiovascular (CV) events compared with placebo, .
"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 (MACE) in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo," Amarin's press release said.
Vascepa carries the generic name icosapent ethyl; it's an ethyl-ester formulation of eicosapentaenoic acid, a member of the omega-3 fatty acid group commonly found in fish oil.
The trial, which began in 2011, had enrolled 8,179 adult patients on statins with median LDL cholesterol of 75 mg/dL (range 41-100) as well as other CV risk factors: elevated triglycerides (150-499 mg/dL, median 216 mg/dL) and either previously diagnosed CV disease or type 2 diabetes plus one other risk factor. Median follow-up was 4.9 years. Amarin said the safety profile was similar to that seen with other omega-3 agents and was similar between the Vascepa and placebo groups.
Major adverse CV events were a composite of CV death, nonfatal MI, nonfatal stroke, coronary revascularization, and unstable angina requiring hospitalization. Details of the results, including the distribution of events among these components, were not included in Amarin's press announcement. The company said full results would be presented at the American Heart Association's scientific meeting in November.
Amarin's statement crowed that the "results stand alone as positive" in comparison with other trials of fish oil products. It did not name the ASCEND trial specifically, reported last month at the European Society of Cardiology meeting, which found no outcomes benefit from 1 g/day of omega-3 fatty acids in diabetes patients. (The dosage in that trial came under criticism, however.) Other placebo-controlled fish-oil trials had also failed to demonstrate clinical benefits.
Vascepa is notable in one other respect: it was the focus of a major court battle that Amarin had waged against the FDA over the company's efforts to talk up the product with physicians, even though marketing claims for event prevention had not gotten the agency's approval. After Amarin won two rounds in federal court, the FDA agreed in early 2016 to modify its policies on off-label promotion (although it still hasn't issued new regulations), while Amarin promised to complete REDUCE-IT and release its results.