Early initiation of eicosapentaenoic acid and statin treatment is associated with better clinical outcomes than statin alone in patients with acute coronary syndromes: 1-year outcomes of a randomized controlled study
Open accessAbstract
BACKGROUND: Early initiation of EPA treatment in combination with a statin within 24h after percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (MI) reduces inflammation and ventricular arrhythmia compared with statin monotherapy; however, the impact of early initiation of EPA treatment on cardiovascular events is unclear. We determined whether early eicosapentaenoic acid (EPA) treatment in patients with acute coronary syndrome (ACS) reduces adverse cardiovascular events. METHODS: This prospective, open-label, blind end point-randomized trial consisted of 241 patients with ACS. Patients were randomly assigned to receive pitavastatin (2mg/day) with or without 1800mg/day of EPA initiated within 24h after PCI. The primary endpoint was defined as cardiovascular events occurring within 1year, including death from a cardiovascular cause, nonfatal stroke, nonfatal MI and revascularization. RESULTS: The mean EPA/arachidonic acid ratio at follow-up was 0.40 in the control group and 1.15 in the EPA group. A primary endpoint event occurred in 11 patients (9.2%) in the EPA group and 24 patients (20.2%) in the control group (absolute risk reduction, 11.0%; hazard ratio, 0.42; 95% confidence interval, 0.21 to 0.87; P=0.02). Notably, death from a cardiovascular cause at 1year was significantly lower in the EPA group than in the control group (0.8% vs. 4.2%, P=0.04). CONCLUSIONS: Early initiation of treatment with EPA combined with statin after successful primary PCI reduced cardiovascular events after ACS. CLINICAL TRIAL REGISTRATION: UMIN Clinical Trials Registry (UMIN-CTR); Registry Number, UMIN000016723; URL, http://www.umin.ac.jp/ctr/index-j.htm.
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Among studies of purified EPA, the RCT by Nosaka et al was identified as a potential outlier.
“Among studies of purified EPA, the RCT by Nosaka et al15 was identified as a potential outlier; this study reported an HR of only 0.22 with wide confidence bounds (95% CI: 0.02-0.99).”
From Effects of Eicosapentaenoic Acid vs Eicosapentaenoic/Docosahexaenoic Acids on Cardiovascular Mortality (2025) · cites this paper as [15]
The Results (§3.2) and Table 2 report an HR of 0.22 for cardiovascular death, but our copy gives its 95% CI as 0.47–0.99, not the cited 0.02–0.99. Calling the trial a potential outlier is the citing authors’ assessment, not a finding attributed to Nosaka et al. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe Nosaka et al RCT reported an HR of 0.22 (95% CI 0.02-0.99).
“Among studies of purified EPA, the RCT by Nosaka et al15 was identified as a potential outlier; this study reported an HR of only 0.22 with wide confidence bounds (95% CI: 0.02-0.99).”
From Effects of Eicosapentaenoic Acid vs Eicosapentaenoic/Docosahexaenoic Acids on Cardiovascular Mortality (2025) · cites this paper as [15]
Section 3.2 and Table 2 report an HR of 0.22 for cardiovascular death, but our copy gives its 95% CI as 0.47–0.99, not 0.02–0.99. The reported HR for the primary composite outcome is 0.42, so the 0.22 estimate applies specifically to cardiovascular death. (LLM, conf=0.90)
Experimental — accuracy not yet measuredSome clinical studies with higher-dose EPA suggest beneficial effects on markers of oxidation and inflammation, coronary plaque characteristics, and major CV events.
“In addition to beneficial changes to TG‐rich lipoproteins and other plasma lipid markers, some clinical studies with higher‐dose EPA also suggest beneficial effects on markers of oxidation and inflammation, coronary plaque characteristics, and major CV events.16, 25, 26, 29, 31, 32, 33”
From Rationale and design of <scp>REDUCE‐IT</scp> : Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (2017) · cites this paper as [33]
Differences in omega-3 fatty acid composition may have contributed to disparate cardiovascular outcomes trial findings.
“Differences in OM-3 fatty acid composition may also have contributed to disparate CVOT findings.”
From Critical Differences Between Dietary Supplement and Prescription Omega-3 Fatty Acids: A Narrative Review (2020) · cites this paper as [29]
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References 43 · Cited by 88
- Authors
- Nosaka, K., Miyoshi, T., Iwamoto, M., Kajiya, M., Okawa, K., Tsukuda, S., Yokohama, F., Sogo, M., Nishibe, T., Matsuo, N., Hirohata, S., Ito, H., & Doi, M.
- Affiliations
- Kagawa Prefectural Central Hospital (JP)
- Okayama University (JP)
- Corresponding author
- Nosaka, Kazumasa
- Miyoshi, Toru
- Iwamoto, Mutsumi
- Kajiya, Masahito
- Okawa, Keisuke
- Tsukuda, Saori
- Yokohama, Fumi
- Sogo, Masahiro
- Nishibe, Tomoyuki
- Matsuo, Naoaki
- Hirohata, Satoshi
- Ito, Hiroshi
- Doi, Masayuki
- Venue
- International Journal of Cardiology
- Publisher
- Elsevier BV
- Published
- 2017-02
- Volume
- 228
- Pages
- 173-179
- ISSN
- 0167-5273 (ISSN-L)
- OpenAlex
- W2551778421
- Cited by
- 88
- References
- 43
- Citations by year
- 2026: 2 · 2025: 12 · 2024: 5 · 2023: 12 · 2022: 8 · 2021: 7 · 2020: 11 · 2019: 11 · 2018: 10 · 2017: 10
- FWCI
- 10.79
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- International Journal of Cardiology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- eicosapentaenoic acid, omega-3 fatty acids, statins, pitavastatin, acute coronary syndrome, acute myocardial infarction, percutaneous coronary intervention, early treatment initiation, cardiovascular events, cardiovascular mortality, revascularization, non-fatal stroke
- MeSH terms
- Aged, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Prospective Studies, Quinolines, Eicosapentaenoic Acid, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Acute Coronary Syndrome, Percutaneous Coronary Intervention
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