September 20, 2014
Amarin Corporation plc announced that it will complete the REDUCE-IT CV outcomes study of icosapent ethyl despite difficulties in obtaining FDA approval for an expanded indication for the drug for the treatment of patients on statin therapy with elevated triglycerides.
The multinational, prospective, double blind trial currently has over 7,000 patients enrolled, with enrollment projected to be completed during 2015. All patients have high or elevated triglycerides despite stable statin therapy, and have either current CHD or risk factors for CHD. Patients will be randomly assigned to either 4 g icosapent ethyl (Vascepa, Amarin) or placebo, with a composite primary endpoint of major adverse CV events, including CV-related death, nonfatal MI, stroke, coronary revascularization or hospitalization due to unstable angina as a result of myocardial ischemia, according to a press release.