REDUCE-IT Trial Result in Doubt

The Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT) trial in patients with an elevated triglyceride level reported a resounding 25% relative reduction in major adverse cardiovascular events with icosapent ethyl compared with placebo (NEJM JW Cardiol Jan 2019 and N Engl J Med 2019; 380:11). However, critics of the trial have suggested that the placebo — pharmaceutical-grade mineral oil — was not inert and, in fact, increased the risk for those in the placebo arm. REDUCE-IT investigators have now provided a comprehensive evaluation of this issue with a biomarker substudy.

This substudy focuses on changes from baseline to 12 and 24 months after randomization in the following biomarkers associated with athe…