Japan: RESPECT-EPA Trial Findings

Using icosapent ethyl, a purified eicosapentaenoic acid (EPA), alongside statin therapy, may reduce the risk of adverse cardiovascular events in chronic coronary artery disease (CAD) patients, results from the RESPECT-EPA trial have shown.

The findings were presented on November 6 during the 2022 Scientific Session of the American Heart Association (AHA) held in Chicago.

Hiroyuki Daida and colleagues conducted the study to evaluate icosapent ethyl compared with control among CAD patients treated with statin therapy.

Study Details

The trial enrolled 3,844 Japanese patients with coronary artery disease treated with statin therapy, out of which 2,506 were randomly allocated to either EPA (1,800 mg/day) or a control group. One thousand three hundred thirty-eight patients were included in a high-EPA/AA (arachidonic acid) group. The median age of the patients was 68 years; 82% were male, 45% had diabetes, and the majority had a history of cardiovascular disease and hypertension. Before inclusion, all participants received statins for at least one month.

Endpoints

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

Findings

• At two years of follow-up, the primary endpoint was the same across the EPA and control groups (4.7%), with a slight variation in favour of EPA at four years (8.6% vs 8.8%) and a more significant benefit with EPA at six years (10.9% vs 14.9%).
• Similar results occurred with the secondary endpoint, with the most significant difference occurring at six years (8.0% in the EPA group vs 11.3% in the control group).
• No significant difference in all-cause mortality was observed between the two groups. There was only a slight difference in cardiovascular mortality at six years post-randomization between the EPA (2.0%) and control (3.0%) groups.
• Among Japanese patients with CAD treated with statin therapy, icosapent ethyl may reduce adverse cardiovascular outcomes. In the icosapent ethyl group, gastrointestinal disorders were more common compared with the control, as was atrial fibrillation.

Limitations

Limitations include the trial being underpowered and not placebo controlled. The results were, however, consistent with JELIS and REDUCE-IT trials in showing a beneficial effect of icosapent ethyl on cardiovascular endpoints.

Reference

Dr Hiroyuki Daida presented the findings at the Scientific Sessions of the American Heart Association, Chicago, IL, on November 6, 2022.