Amarin’s Vascepa Shown to Reduce STEMI and NSTEMI in New REDUCE-IT Data

August 26, 2022—Amarin Corporation plc announced that new data from the REDUCE-IT trial demonstrate that icosapent ethyl (IPE; Vascepa in the United States and Vazkepa in Europe) significantly reduced ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and other myocardial infarction (MI) subtypes in patients with established cardiovascular disease or diabetes with risk factors.

The data were presented during a late-breaking science secession at the European Society of Cardiology Congress held August 26-29 in Barcelona, Spain.

The REDUCE-IT study randomized 8,179 adult statin-treated patients with elevated triglycerides and either established cardiovascular disease or diabetes plus risk factors to IPE or placebo. The median follow-up was 4.9 years.

The trial’s primary composite endpoint was cardiovascular death, nonfatal MI, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina, and the key secondary composite endpoint was cardiovascular death, nonfatal MI, or nonfatal stroke. Prespecified and post hoc analyses examined MI subtypes, which were independently adjudicated by a blinded Clinical Endpoint Committee.

According to Amarin, REDUCE-IT data showed a 40% reduction of STEMI and a 27% reduction of NSTEMI after treatment with IPE compared to placebo. Also, treatment with IPE reduced the primary composite endpoint and key secondary composite endpoint by 25% and 26%, respectively.

“This analysis of REDUCE-IT clearly shows that IPE 4 g/day as an adjunct to statin therapy in high-risk patients with residual hypertriglyceridemia provides a large and significant reduction in heart attacks,” commented REDUCE-IT Principal Investigator Deepak L. Bhatt, MD. “Importantly, these new data show a significant reduction in the most important type of heart attack known as STEMI, as well as other MI subtypes.”

Dr. Bhatt is Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

Additionally, the company highlighted the following results from Amarin-funded time-to–first event analyses:

• IPE significantly reduced MI (hazard ratio (HR), 0.69; 95% CI, 0.58-0.81; P < .0001), with a number needed to treat of 39.
• IPE significantly reduced STEMI (HR, 0.60; 95% CI, 0.44-0.81; P = .0008) and NSTEMI (HR = 0.73; 95% CI, 0.60-0.89; P = .001).
• There were clinically important, statistically significant reductions in MI subtypes, including MI leading to cardiac arrest (HR, 0.49; 95% CI, 0.28-0.87; P = .01) and resuscitated MI (HR, 0.34; 95% CI, 0.15-0.76; P = .006).
• IPE significantly reduced the overall burden of total (first and subsequent) STEMI (rate ratio [RR] = 0.59; 95% CI, 0.43-0.80; P = .0006) and total NSTEMI (RR, 0.72; 95% CI, 0.58-0.88; P = .002) versus placebo.