Phase 3 Study Update of Epanova for Hypertriglyceridemia
Omthera Pharmaceuticals announced the results from EVOLVE, the Phase 3 study of Epanova for treatment of patients with very high triglycerides.
The EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial was a 12-week, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of three doses of Epanova in patients with fasting triglyceride levels 500–2,000mg/dL. A total of 399 patients were randomized to 2, 3, or 4g of Epanova or 4g of olive oil.
Epanova met the study's primary endpoint by significantly reducing triglycerides in all dose groups, with median decreases in triglycerides from baseline to end of treatment of approximately 26% in the 2g cohort and 31% for those subjects on the 4g dose. In addition, Epanova demonstrated a meaningful decrease of 8% in non-HDL cholesterol in both the 2 and 4g dose groups.
Epanova is an omega-3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
For more information call (908) 741-4399 or visit www.omthera.com.