The Road to Approval: a Perspective on the Role of Icosapent Ethyl in Cardiovascular Risk Reduction
Open accessAbstract
PURPOSE OF REVIEW: Epidemiological studies have long suggested the cardiovascular benefits of omega-3 fatty acids (OM3FAs). However, until recently, clinical trials using OM3FAs have been largely negative with respect to their cardioprotective effects. In this review, we aim to summarize key clinical trials, examine the clinical benefits of eicosapentaenoic acid (EPA) and potential mechanisms, and review the changes in guidelines and recommendations. RECENT FINDINGS: The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) has demonstrated significant cardiovascular mortality benefits of purified EPA ethyl ester, with a 25% relative risk reduction in major cardiovascular events. As first of its class to be approved, icosapent ethyl offers a new option to further reduce cardiovascular risks in patients already treated with maximally tolerated statins.
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After a median follow-up of 4.9 years, the study drug demonstrated a 25% relative risk reduction in the primary composite end point of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or unstable angina.
“After a median follow-up period of 4.9 years, the study drug demonstrated a 25% relative risk reduction in the primary composite end point of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or unstable angina.”
From Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL (2021) · cites this paper as [19]
The Existing Clinical Trials section reports that REDUCE-IT found a 25% relative risk reduction with icosapent ethyl and lists the claimed components of the primary composite endpoint. Our copy does not state the claimed median follow-up of 4.9 years (searched: “median follow-up of 4.9 years” and “4.9”). (LLM, conf=0.86)
Experimental — accuracy not yet measuredPatients treated with icosapent ethyl had a 26% relative risk reduction in the composite of cardiovascular death, myocardial infarction, or stroke.
“The study further demonstrated that patients treated with icosapent ethyl had a 26% relative risk reduction in the composite of cardiovascular death, myocardial infarction, or stroke.”
From Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL (2021) · cites this paper as [19]
The Existing Clinical Trials section reports that icosapent ethyl reduced cardiovascular events in REDUCE-IT. It gives a 25% relative risk reduction for a five-component endpoint, however, not a 26% reduction for the three-component composite of cardiovascular death, myocardial infarction, or stroke. No page number is available in our copy. (LLM, conf=0.87)
Experimental — accuracy not yet measured
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Majithia, A., Bhatt, D. L., Friedman, A. N., Miller, M., Steg, P. G., Brinton, E. A., Jacobson, T. A., Ketchum, S. B., Juliano, R. A., Jiao, L., et al. (2021) · Circulation · doi:10.1161/circulationaha.121.055560 · Cited by 74 · see citing works
Self-citationGaba, P., Bhatt, D. L., Steg, P. G., Miller, M., Brinton, E. A., Jacobson, T. A., Ketchum, S. B., Juliano, R. A., Jiao, L., Doyle, R. T., et al. (2022) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2022.02.035 · Cited by 61 · see citing works
Self-citation
- Authors
- Wang, X., Verma, S., Mason, R. P., & Bhatt, D. L.
- Affiliations
- Brigham and Women's Hospital (US)
- University of Toronto (CA)
- Corresponding author
- Bhatt, Deepak L.
- Venue
- Current Diabetes Reports
- Published
- 2020-10-23
- Volume
- 20
- Issue
- 11
- Pages
- 65-65
- ISSN
- 1534-4827 (ISSN-L)
- 1539-0829
- PMC
- PMC7584545
- OpenAlex
- W3094072653
- Cited by
- 24
- References
- 23
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 4 · 2023: 2 · 2022: 8 · 2021: 6
- Type
- book review
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Current Diabetes Reports (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Amarin Corporation
- Amarin Pharma
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Keywords
- icosapent ethyl, eicosapentaenoic acid, omega-3 fatty acids, cardiovascular risk reduction, REDUCE-IT trial, cardiovascular mortality, statin-treated patients, cardioprotection mechanisms, drug approval, clinical trial results
- MeSH terms
- Heart Disease Risk Factors, Cardiovascular Diseases, Humans, Risk Factors, Eicosapentaenoic Acid, Fatty Acids, Omega-3
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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