Robustness of highly purified eicosapentaenoic acid trials and their cardiovascular outcomes
Zuin M, Bilato C
Journal of cardiovascular medicine (Hagerstown, Md.) · 0 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Revisión sistemática (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2026-03-05 · J Cardiovasc Med (Hagerstown) · vol. 27 · número 5 · págs. 398–407
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 0 citas · más que el 15% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 30 trabajos
- Acceso
- De pago
- Áreas de investigación
- Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Antiplatelet Therapy and Cardiovascular Diseases
- Palabras clave
- eicosapentaenoic acid, omega-3 fatty acids, cardiovascular outcomes, fragility index, fragility quotient, statin therapy, residual cardiovascular risk, triglyceride elevation, myocardial infarction, stroke, revascularization
- MeSH
- humans, cardiovascular diseases, eicosapentaenoic acid, treatment outcome, risk assessment, randomized controlled trials as topic, heart disease risk factors
2 autores
- Marco Zuin🇮🇹 · autor de correspondenciaUniversity of Padua; University of Ferrara
- Claudio Bilato
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aims
Despite contemporary statin therapy, patients with atherosclerotic cardiovascular disease or high cardiovascular risk experience a residual risk of major adverse events. Eicosapentaenoic acid (EPA) has been evaluated for additional cardiovascular risk reduction, but the consistency and robustness of trial results remain uncertain. The aim of this study was to assess the robustness of randomized controlled trials (RCTs) of highly purified EPA for cardiovascular outcomes.
Methods
MEDLINE and Scopus were searched for phase 3/4 RCTs of EPA published through June 2025. Eligible studies were randomized and placebo-controlled, and reported dichotomous cardiovascular outcomes. Three trials met the inclusion criteria: REDUCE-IT, RESPECT-EPA, and JELIS. Primary and secondary cardiovascular endpoints were extracted. Conventional effect estimates (hazard ratios, relative risk reduction, number needed to treat) were calculated, and robustness was evaluated using the fragility index and fragility quotient.
Results
EPA significantly reduced the primary composite endpoint in REDUCE-IT (17.2 vs. 22.0%; hazard ratio 0.75; fragility index 123, fragility quotient 0.01), RESPECT-EPA (9.1 vs. 12.6%; hazard ratio 0.71; fragility index 49, fragility quotient 0.01), and JELIS (2.8 vs. 3.5%; hazard ratio 0.81; fragility index 15, fragility quotient 0.01). Secondary endpoints showed consistent but heterogeneous reductions in nonfatal myocardial infarction, stroke, and revascularization, with robustness highest in REDUCE-IT and more fragile results in RESPECT-EPA and JELIS. Differences in population phenotypes, background statin therapy, trial design, and endpoint definitions contributed to variability in the effect size and fragility.
Conclusion
EPA added to statins lowers cardiovascular events, most robustly in high-risk patients with elevated triglycerides. Trial design, endpoints, and patient characteristics drive heterogeneity, while fragility analyses complement conventional metrics in interpreting outcomes.
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