{"id":"6625400e947e","type":"article","url":"https://hartvaat.nl/2020/12/08/hoog-dosis-omega-3-versus-maisolie-bij-hoog-cv-risico-jama-strength/","title":"Hoog-dosis omega-3 versus maisolie bij hoog CV-risico: JAMA STRENGTH","title_en":"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.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2020.22258","source_url":"https://doi.org/10.1001/jama.2020.22258","authors":["Stephen J Nicholls","A Michael Lincoff","Michelle Garcia","Dianna Bash","Christie M Ballantyne","Philip J Barter","Michael H Davidson","John J P Kastelein","Wolfgang Koenig","Darren K McGuire","Dariush Mozaffarian","Paul M Ridker","Kausik K Ray","Brian G Katona","Anders Himmelmann","Larrye E Loss","Martin Rensfeldt","Torbjörn Lundström","Rahul Agrawal","Venu Menon","Kathy Wolski","Steven E Nissen"],"significance":9,"published":"2020-12-08","source_date":"2020-12-08","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/omega3-vetzuren-cardiologie/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"The STRENGTH trial showed that high-dose omega-3 fatty acids (EPA plus DHA) did not reduce major cardiovascular events compared with corn oil in statin-treated patients at high cardiovascular risk. The contrasting result with REDUCE-IT (EPA only) suggested that DHA may attenuate EPA's cardiovascular benefit or that the mineral oil placebo in REDUCE-IT may have influenced outcomes.","created":"2026-07-03T10:28:56Z","updated":"2026-07-03T13:28:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"JAMA STRENGTH trial die hoog-dosis omega-3 (EPA+DHA) vergeleek met maisolie bij hoog CV-risico. Negatief — in contrast met REDUCE-IT (EPA alleen).","abstract_original":"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."}