Financiado en parte por Amgen, Eli Lilly and Company, AstraZeneca, Novo Nordisk, Esperion Therapeutics
Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial
Nicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ, Davidson MH, Kastelein JJP, Koenig W, McGuire DK, Mozaffarian D, Ridker PM, Ray KK, Katona BG, Himmelmann A, Loss LE, Rensfeldt M, Lundström T, Agrawal R, Menon V, Wolski K, Nissen SE
JAMA · 762 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Amgen
- Empresa
- Eli Lilly and Company
- Empresa
- AstraZeneca
- Universidad u hospital
- Cleveland Clinic
- Empresa
- Novo Nordisk
- Empresa
- Esperion Therapeutics
Según 6 financiadores declarados.
Publicación
- Publicado
- 2020-11-15 · JAMA · vol. 324 · número 22 · pág. 2268
- Editorial
- American Medical Association
- Citado
- 1,028 citas · más que el 100% de estudios similares · 64.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 35 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Natural Products and Biological Research
- Palabras clave
- Medicine, Adverse effect, Corn oil, Omega, Internal medicine
- MeSH
- humans, cardiovascular diseases, hypertriglyceridemia, cholesterol, corn oil, docosahexaenoic acids, eicosapentaenoic acid, triglycerides, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, double-blind method, adult, middle aged, female, male, heart disease risk factors
22 autores
- Stephen James Nicholls🇦🇺Monash University
- A. Michael Lincoff🇺🇸Cleveland Clinic; Center for Clinical Research (United States)
- Michelle Garcia🇺🇸Cleveland Clinic; Center for Clinical Research (United States)
- Dianna Bash🇺🇸Cleveland Clinic; Center for Clinical Research (United States)
- Christie Mitchell Ballantyne🇺🇸Baylor College of Medicine
- Philip J. Barter🇦🇺UNSW Sydney
- Michael H. Davidson🇺🇸University of Chicago
- John J.P. Kastelein🇳🇱Amsterdam UMC Location University of Amsterdam
- Wolfgang Köenig🇩🇪German Centre for Cardiovascular Research; Deutsches Herzzentrum München; Technical University of Munich
- Darren K. McGuire🇺🇸The University of Texas Southwestern Medical Center
- Dariush Mozaffarian🇺🇸Tufts University
- Paul M. Ridker🇺🇸Harvard University
- Kausik Kumar Ray🇬🇧Imperial College London
- Brian G. Katona🇺🇸AstraZeneca (United States)
- Anders Himmelmänn🇸🇪AstraZeneca (Sweden)
- Larrye E. Loss🇺🇸AstraZeneca (United States)
- Martin Rensfeldt🇸🇪AstraZeneca (Sweden)
- Torbjörn S. Lundström🇸🇪AstraZeneca (Sweden)
- Rahul Agrawal🇸🇪AstraZeneca (Sweden)
- Venu Menon🇺🇸Cleveland Clinic; Center for Clinical Research (United States)
- Kathy Wolski🇺🇸Cleveland Clinic; Center for Clinical Research (United States)
- Steven E. Nissen🇺🇸 · autor de correspondenciaCleveland Clinic; Center for Clinical Research (United States)
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
It remains uncertain whether the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) reduce cardiovascular risk.
Objective
To determine the effects on cardiovascular outcomes of a carboxylic acid formulation of EPA and DHA (omega-3 CA) with documented favorable effects on lipid and inflammatory markers in patients with atherogenic dyslipidemia and high cardiovascular risk.
Design, setting, and participants
A double-blind, randomized, multicenter trial (enrollment October 30, 2014, to June 14, 2017; study termination January 8, 2020; last patient visit May 14, 2020) comparing omega-3 CA with corn oil in statin-treated participants with high cardiovascular risk, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol (HDL-C). A total of 13 078 patients were randomized at 675 academic and community hospitals in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa.
Interventions
Participants were randomized to receive 4 g/d of omega-3 CA (n = 6539) or corn oil, which was intended to serve as an inert comparator (n = 6539), in addition to usual background therapies, including statins.
Main outcomes and measures
The primary efficacy measure was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.
Results
When 1384 patients had experienced a primary end point event (of a planned 1600 events), the trial was prematurely halted based on an interim analysis that indicated a low probability of clinical benefit of omega-3 CA vs the corn oil comparator. Among the 13 078 treated patients (mean [SD] age, 62.5 [9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein [LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240 mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity C-reactive protein level, 2.1 mg/L), 12 633 (96.6%) completed the trial with ascertainment of primary end point status. The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84). A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).
Conclusions and relevance
Among statin-treated patients at high cardiovascular risk, the addition of omega-3 CA, compared with corn oil, to usual background therapies resulted in no significant difference in a composite outcome of major adverse cardiovascular events. These findings do not support use of this omega-3 fatty acid formulation to reduce major adverse cardiovascular events in high-risk patients.
Trial registration
ClinicalTrials.gov Identifier: NCT02104817.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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