The efficacy and safety of Vascepa were studied in two Phase 3 clinical trials, the MARINE trial and the ANCHOR trial. Both studies were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin is also enrolling patients in a cardiovascular outcomes study designed to evaluate the efficacy of Vascepa in reducing major cardiovascular events in a high-risk patient population on statin therapy called REDUCE-IT. REDUCE-IT is also being conducted under a Special Protocol Assessment, or SPA, with FDA.
The MARINE study: A Phase 3, multi-center, placebo-controlled, randomized, double-blind, 12-week study that treated patients with severe (≥500 mg/dL) hypertriglyceridemia (very high triglycerides) with 229 patients enrolled. The primary endpoint in the trial was the percentage change in triglyceride level from baseline compared to placebo after 12 weeks of treatment. In November, 2010, Amarin reported top-line data for the MARINE trial which met its primary endpoints.
The MARINE trial demonstrated that Vascepa significantly lowered triglyercides without increasing LDL-C (non-significant decrease of -2%). In addition, MARINE demonstrated a statistically significant decrease in multiple other important lipid biomarkers including non-HDL-C, apolipoprotein B (apo B), lipoprotein-phospholipase A2 (Lp-PLA2), very low-density lipoprotein cholesterol (VLDL-C), Total Cholesterol (TC) and high-sensitivity C-reactive protein (hsCRP).
Vascepa® (icosapent ethyl) capsules, a therapy approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (patient population studied in the MARINE trial), more commonly known as very high triglycerides, or VHTG, is now available by prescription.
In the MARINE study, the only reported adverse reaction with
an incidence >2% and greater than placebo in Vascepa
treated patients was arthralgia (2.3% for Vascepa vs. 1.0%
*based on pooled data across two clinical studies (MARINE and ANCHOR) that included patients with triglycerides values of 200 to 2000 mg/dL
For more information see www.vascepa.com.
The ANCHOR trial: A multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal Phase 3 study in patients with high triglycerides (≥200 mg/dL and <500 mg/dL) who were also on statin therapy. 702 patients were enrolled in this trial. The primary endpoint in the trial was the percentage change in triglyceride level from baseline of Vascepa-treated subjects compared to placebo after 12 weeks of treatment. In April 2011, Amarin reported top-line results from the ANCHOR trial. The ANCHOR trial met its primary and secondary endpoints.
One of the ANCHOR trial's key secondary endpoints was to demonstrate a lack of elevation in LDL-C in order to avoid offset to the target of cholesterol lowering therapy. The trial's non-inferiority criterion for LDL-C was met at both Vascepa doses. For the 4 grams per day Vascepa group, LDL-C decreased significantly (-6.2%, P=0.0067) from baseline versus placebo, demonstrating superiority over placebo.
Other secondary efficacy endpoints included the median placebo-adjusted percent change in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), and lipoprotein-associated phospholipase A2 (Lp-PLA2) and very-low-density lipoprotein cholesterol (VLDL-C).
In this trial, the safety profile of Vascepa was comparable to placebo and there were no treatment-related serious adverse events.
The FDA has not completed its review of the ANCHOR trial. Vascepa is not approved for use in this patient population.
The REDUCE-IT (Reduction of Cardiovascular Events Outcomes trial): A multi-center, prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of Vascepa as an add-on to statin therapy, in reducing the first major cardiovascular event in an high-risk patient population compared to statin therapy alone. Patients enrolled in the study have elevated triglyceride levels (>150 mg/dL) and at least one other defined cardiovascular risk factor. The control arm of the study is comprised of patients on optimized statin therapy. The active arm of the study is comprised of patients on optimized statin therapy plus Vascepa. Entry requirements for participants in this study include elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. This study is being conducted internationally and Amarin anticipates utilizing more than 300 clinical sites in connection with the trial, the largest number of which will be in the United States. In December 2011, Amarin announced that the first patient was dosed in the REDUCE-IT study. The study is scheduled to be completed in approximately six years and is anticipated to include approximately 8,000 patients.
This page was last updated on January 25, 2013.