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REDUCE-IT CV outcomes trial of icosapent ethyl to continue
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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.
“For decades, clinical data have suggested that triglycerides play a role in [CVD], but there remains an unmet need for both triglyceride-focused and high-dose omega-3 outcomes data,” Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart and Vascular Center, and chief medical editor of Cardiology Today’s Intervention, said in a press release. “Since initiation of the REDUCE-IT study, published data have continued to reinforce that elevated triglyceride levels play a critical role in [CV] risk.”
Deepak L. Bhatt
Icosapent ethyl is currently approved, in addition to dietary changes, for the reduction of triglycerides among adult patients with levels ≥500 mg/dL. According to the release, results from the phase 3 ANCHOR trial indicated a potential beneficial impact on triglycerides and other biomarkers of lipids, lipoproteins and inflammation among patients with CV risk factors. However, the FDA has denied three appeals from Amarin to reinstate the special protocol assessment agreement for the ANCHOR trial, as the company seeks to receive an expanded indication for icosapent ethyl to include adult patients with triglycerides between 200 mg/dL and 500 mg/dL who are receiving statin therapy.
In its most recent denial, the FDA stated that the ANCHOR study indicated a greater reduction in triglycerides with icosapent ethyl vs. placebo, and called for the company to continue its REDUCE-IT trial. However, they concluded that available data and information were not sufficient to support a reduction in triglycerides as a “validated surrogate” for reduction of CV risk in the proposed population, according to the release.