Amarin’s Vascepa Shows Lower Risk of Fatal CV Events in REDUCE-IT Prior PCI Post Hoc Subanalysis

March 10, 2022—Amarin Corporation plc announced the publication of new REDUCE-IT data analysis for icosapent ethyl (Vascepa) for patients who have received a percutaneous coronary intervention (PCI) and are at high risk for experiencing a stroke, myocardial infarction (MI), or fatal cardiovascular (CV) event.

Amarin stated that the REDUCE-IT study enrolled 8,179 patients for a median of 4.9 years, who were all receiving a stable dose of a statin for at least 4 weeks. All patients had controlled low-density lipoprotein cholesterol, elevated triglyceride levels, and were either 45 years of age or older, with established CV disease, or were age ≥ 50 years, with diabetes and other CV risk factors.

According to the company, the findings further the clinical evidence base for icosapent ethyl treatment in patients with previous PCI at risk of a recurrent CV event.

The REDUCE-IT Prior PCI post hoc subanalysis findings were published by Benjamin E. Peterson, MD, et al online in the Journal of the American Heart Association.

Deepak L. Bhatt, MD, Principal Investigator of REDUCE-IT, is Senior Investigator of the REDUCE-IT Prior PCI analyses. 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.

“This analysis from REDUCE-IT highlights the benefits of icosapent ethyl in patients with elevated triglycerides and a history of prior PCI, a commonly performed procedure,” commented Dr. Bhatt in Amarin’s press release. “The findings of benefit in at-risk patients with prior PCI are consistent with previously published coronary revascularization data demonstrating reductions in first and total coronary revascularization events of 34% and 36%, respectively, in the overall REDUCE-IT population.”

Dr. Bhatt continued, “Patients on standard of care treatment who nevertheless have elevated triglycerides are at high-risk for recurrent CV events. Icosapent ethyl has the potential to benefit a large proportion of these patients, including those with a history of prior PCI.”

As summarized in Amarin’s press release, the subanalysis was composed of 3,408 patients who had undergone a previous PCI (41.7% of the initial REDUCE-IT study population). The median time after PCI for these patients was 2.9 years.

Baseline characteristics were similar among patients randomized to icosapent ethyl versus placebo. Of those patients with previous PCI included in the subanalysis receiving standard of care treatment only, 37.6% experienced a major CV event (CV death, MI, stroke, coronary revascularization, or unstable angina requiring hospitalization), compared with 25.6% of patients receiving icosapent ethyl.

In patients with a history of PCI, icosapent ethyl treatment versus placebo reduced the first primary composite endpoint of CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina, by 34% (absolute risk reduction of 8.5%; hazard ratio, 0.66; 95% CI, 0.58-0.76; P < .001; number needed to treat [NNT] = 12).

Additionally, Amarin reported that icosapent ethyl treatment versus placebo demonstrated the following:

• 39% reduction in total events (relative risk, 0.61; 95% CI, 0.52-0.72; P < .001).
• 34% reduction in the key secondary composite endpoint of CV death, nonfatal MI, or nonfatal stroke (absolute risk reduction 5.4%; hazard ratio, 0.66; 95% CI, 0.56-0.79; P < .001; NNT = 19).
• 40% risk reduction of repeat coronary revascularization (absolute risk reduction 7.7%; hazard ratio, 0.6; 95% CI, 0.51-0.70; P < .001).

Safety findings in the REDUCE-IT Prior PCI subgroup were consistent with the full study cohort, advised the company.

Amarin emphasized that this post hoc analysis was limited by its exploratory nature. Other limitations noted by the authors include that REDUCE-IT was not powered for subgroup analyses and all P values should be considered hypothesis generating.

Vascepa was launched in the United States in January 2020 after FDA approval for the treatment of high-risk patients with persistent CV risk after statin therapy. Vascepa was initially launched in the United States in 2013 based on the drug’s initial FDA-approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

Vascepa is also approved and commercially available in Canada, Lebanon, and the United Arab Emirates.

In March 2021, the company received marketing authorization in the European Union for icosapent ethyl under the brand name Vazkepa for the reduction of risk of CV events in patients at high CV risk, stated the company.