Adding Icosapent Ethyl to Statin Therapy Cuts Stroke Risk, Analysis of REDUCE-IT Trial Finds

Adding icosapent ethyl (Vascepa^®, Amarin Corporation) to treatment regimens that already included statins was found to further decrease a patient’s risk of stroke in the latest analysis of the REDUCE-IT trial to be presented at the American Stroke Association’s (ASA) International Stroke Conference, March 17-19, 2021.

Results of the new analysis, REDUCE-IT STROKE, showed that icosapent ethyl reduced the risk of a first ischemic stroke by an additional 36% in patients with established cardiovascular disease (CVD) or diabetes and with other CV risk factors who were already taking statin medications to treat elevated cholesterol.

“The REDUCE-IT STROKE analyses provide important data supporting a new approach to prevent strokes using icosapent ethyl in appropriate patients,” said lead author Deepak L. Bhatt, MD, MPH, executive director, Interventional Cardiovascular Programs, Brigham and Women’s Hospital, and principal investigator of the REDUCE-IT trial, in a Amarin press release. “The findings of benefit in at-risk patients include significant reductions in overall strokes and in ischemic strokes. Importantly, with respect to safety, we did not observe any significant increase in hemorrhagic stroke.”

The landmark REDUCE-IT trial examined 8179 patients aged ≥45 years with established CVD or diabetes and other CV risk factors such as elevated triglyceride levels. Participants were randomized to receive 2 g of icosapent ethyl twice daily or placebo

Completed in 2018, the study showed that adding icosapent ethyl reduced the risk of serious CV events (CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, unstable angina) by 25% vs placebo.

In REDUCE-IT STROKE, Bhatt and colleagues performed an additional analysis of the impact of icosapent ethyl on stroke in the same participants of the original REDUCE-IT study.

Researchers found that event rates for time to first fatal or nonfatal stroke were 2.4% in the icosapent ethyl group vs 3.3% in the placebo group, for a relative risk reduction (RRR) of 28% (p=0.01). Also, ischemic stroke time to first event rates were 2% for icosapent ethyl vs 3% for placebo for a RRR of 36% (p=0.002).

Researchers also found:

• For every 1000 patients treated with icosapent ethyl for 5 years, approximately 14 strokes (fatal or nonfatal) were averted.
• Hemorrhagic stroke occurred at low rates with no significant difference among those treated with icosapent ethyl or placebo.

“One study limitation is that icosapent ethyl may increase the risk of minor bleeding,” said Bhatt in an ASA press release.