Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy-Statin and Eicosapentaenoic Acid (RESPECT-EPA)
Miyauchi K, Iwata H, Nishizaki Y, Inoue T, Hirayama A, Kimura K, Ozaki Y, Murohara T, Ueshima K, Kuwabara Y, Tanaka-Mizuno S, Yanagisawa N, Sato T, Daida H, RESPECT-EPA Investigators
Circulation · 73 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2024-06-14 · Circulation · vol. 150 · issue 6 · pp. 425–434
- Publisher
- Lippincott Williams & Wilkins
- Cited
- 90 citations · more than 100% of similar papers · 17.4× the field average
- Impact
- Top 10% most cited in its field
- References
- 33 works
- Access
- Paywalled
- Research areas
- Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Eicosanoids and Hypertension Pharmacology
- Keywords
- Medicine, Eicosapentaenoic acid, Randomized controlled trial, Secondary prevention, Statin, Internal medicine, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Physical therapy, Oncology, Pharmacology, Fatty acid, Polyunsaturated fatty acid, Biochemistry
- MeSH
- humans, eicosapentaenoic acid, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, drug therapy, combination, prospective studies, aged, middle aged, japan, female, male, coronary artery disease, secondary prevention
15 authors
From JP, GR
- Katsumi MiyauchiJuntendo University
- Hiroshi IwataJuntendo University
- Yuji NishizakiJuntendo University
- Teruo InoueJapanese Red Cross Society, Japan; Red Cross Hospital; Dokkyo Medical University
- Atsushi HirayamaFukujuji Hospital
- KAZUO K. KIMURAYokohama City University Medical Center; Yokohama City University
Abstract
Background
Low plasma levels of eicosapentaenoic acid (EPA) are associated with cardiovascular events. This trial aimed to assess the clinical benefits of icosapent ethyl in patients with coronary artery disease, a low EPA/arachidonic acid (AA) ratio, and statin treatment.
Methods
In this prospective, multicenter, randomized, open-label, blinded end-point study, patients with stable coronary artery disease and a low EPA/AA ratio (<0.4) were randomized to EPA (1800 of icosapent ethyl administered daily) or control group. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina pectoris, and coronary revascularization. The secondary composite end points of coronary events included sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina requiring emergency hospitalization and coronary revascularization, or coronary revascularization.
Results
Overall, 3884 patients were enrolled at 95 sites in Japan. Among them, 2506 patients had a low EPA/AA ratio, and 1249 and 1257 patients were randomized to the EPA and control group, respectively. The median EPA/AA ratio was 0.243 (interquartile range, 0.180-0.314) and 0.235 (interquartile range, 0.163-0.310) in the EPA and control group, respectively. Over a median period of 5 years, the primary end point occurred in 112 of 1225 patients (9.1%) and 155 of 1235 patients (12.6%) in the EPA and control group, respectively (hazard ratio, 0.79 [95% CI, 0.62-1.00]; P=0.055). Meanwhile, the secondary composite end point of coronary events in the EPA group was significantly lower (81/1225 [6.6%] versus 120/1235 [9.7%] patients; hazard ratio, 0.73 [95% CI, 0.55-0.97]). Adverse events did not differ between the groups, but the rate of new-onset atrial fibrillation was significantly higher in the EPA group (3.1% versus 1.6%; P=0.017).
Conclusions
Icosapent ethyl treatment resulted in a numerically lower risk of cardiovascular events that did not reach statistical significance in patients with chronic coronary artery disease, a low EPA/AA ratio, and statin treatment.
Registration
URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000012069.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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