The capsules of icosapent ethyl, which is derived from fish, showed a 25% relative risk reduction compared to placebo.
Amarin Corporation plc today announced results from the REDUCE-IT cardiovascular outcomes trial. The trial studied Vascepa (icosapent ethyl) compared to placebo in statin-treated adults with elevated cardiovascular risk.
REDUCE-IT met its primary efficacy endpoint, achieving an approximately 25% relative risk reduction (P <.001) in major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.
“We are delighted with these topline study results,” said John F. Thero, president and CEO of Amarin, in a statement. “Given Vascepa is affordably priced, orally administered and has a favorable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT.”
The randomized, placebo-controlled trial included 8179 adults treated with statins who had LDL-C between 41-100 mg/dL (median baseline LDL-C 75 mg/dL). Participants also had various risk factors including elevated triglycerides, either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other CV risk factor (primary prevention cohort).
REDUCE-IT participants were given 4 grams per day of Vascepa or placebo. The median follow-up time was 4.9 years.
Vascepa (icosapent ethyl) capsules contain the omega-3 acid commonly known as EPA (eicosapentaenoic acid) in ethyl-ester form. It is not fish oil but is derived from fish.
“Considered against the backdrop of multiple unsuccessful cardiovascular outcomes studies of earlier generation drug therapies, including multiple recent failed cardiovascular studies of omega-3 mixture products that contain the omega-3 acid DHA, REDUCE-IT topline results stand alone as positive and confirm our hypothesis that pure EPA Vascepa at 4 grams/day can provide additional cardiovascular risk reduction benefit on top of LDL-C control with standard of care statin therapy in studied patients,” added Craig Granowitz, MD, PhD, senior vice president and chief medical officer of Amarin.
The company reported that safety results from REDUCE-IT were consistent with the current FDA-approved labeling. The Vascepa (icosapent ethyl) Prescribing Information lists just one common adverse reaction (incidence >2% and greater than placebo), arthralgia. The Prescribing Information also advises the monitoring of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in patients with hepatic impairment.
Vascepa is currently indicated as a supplement to diet to reduce triglyceride levels in adults with severe (≥500 mg/dL) hypertriglyceridemia. The recommended dosage is 4 grams per day taken as four .5-gram capsules or two 1-gram capsules twice daily, accompanied with food.
More detailed data from the REDUCE-IT trial will be presented at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois, as late-breaking clinical trial results.