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.
