Use of highly purified eicosapentaenoic acid (EPA) demonstrated borderline statistical significance in reducing the risk of adverse cardiovascular events in Japanese patients with chronic coronary artery disease (CAD) who were also being treated with statins, based on results from the RESPECT-EPA trial presented Nov. 6 during AHA 2022 in Chicago.

The trial enrolled 3,844 patients, of whom 2,506 were randomized to either EPA (1,800 mg/day) or a control group. Additionally, 1,338 patients were included in a high-EPA/AA group. The median age of study participants was approximately 68 years, roughly 82% were male, 45% had diabetes mellitus, and the majority had hypertension and a history of cardiovascular disease. All participants were receiving statins for at least one month before inclusion.

The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal cerebral infarction, unstable angina pectoris requiring emergency hospitalization and coronary revascularization procedure, and revascularization procedure based on clinical findings. The secondary endpoint was the composite events of CAD, composite events of stroke, and events related to death.

Results found the primary endpoint was the same across the EPA and control groups at two years follow-up (4.7%), with a slight variation in favor of EPA at four years (8.6% vs. 8.8%), and a greater benefit with EPA at six years (10.9% vs. 14.9%). Similar results occurred with the secondary endpoint, with the greatest difference occurring at six years (8.0% in the EPA group vs. 11.3% with the control group). There was no significant difference in all-cause mortality between the two groups and only a slight significant different in cardiovascular mortality at six years post-randomization between the EPA (2.0%) and control (3.0%) groups.

"Present findings indicate a possible prognostic benefit of EPA in chronic CAD patients with statins whose EPA/AA ratio was low (<0.4)," said Hiroyuki Daida, MD, FACC, when presenting the findings. However, he noted that the baseline level of EPA in Japanese individuals has been considered to be relatively higher than that in Western countries, which could be a limitation to the study. Additionally, he highlighted that the study might be underpowered, as the actual event rate was lower than estimated, and the alternative hazard ratio was set as 0.7.

Clinical Topics: Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins, Novel Agents, Statins

Keywords: AHA Annual Scientific Sessions, AHA22, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Eicosapentaenoic Acid, Secondary Prevention, Cardiovascular Diseases, Drug Therapy, Combination, ACC International

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