CV outcomes trial on omega-3 acid met primary endpoint

The REDUCE-IT trial met its primary endpoint demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance (p<0.001), in major adverse CV events (MACE), in the intent-to-treat patient population with use of the omega-3 acid EPA (an omega-3 fatty acid contained in fish oil, in ethyl-ester form) 4 grams/day, as compared to placebo after a median follow-up time of 4.9 years.

REDUCE-IT is the first global CV outcomes study to prospectively evaluate the effect of the omega-3 acid EPA, or any therapy, in adult patients (n=8,179) with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various CV risk factors including persistent elevated TGs between 150-499 mg/dL (median baseline 216 mg/dL) and either established CV disease (secondary prevention cohort) or diabetes mellitus and at least one other CV risk factor (primary prevention cohort).

The REDUCE-IT hypothesis tested whether additional CV risk reduction beyond LDL-C controlled with statin therapy could be achieved in high risk patients with the putative cardioprotective effects of EPA 4 grams/day.

REDUCE-IT results have been accepted for presentation at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois.

Source: press release Amarin, September 24, 2018