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Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk
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Παρασκευή 18 Ιούν 2021
Stephen J. Nicholls, MBBS, PhD; A. Michael Lincoff, MD; Michelle Garcia, RN, BSN, CCRC; Dianna Bash, BSN; Christie M. Ballantyne, MD; Philip J. Barter, MBBS, PhD; Michael H. Davidson, MD; John J. P. Kastelein, MD, PhD; Wolfgang Koenig, MD; Darren K. McGuire, MD, MHSc; Dariush Mozaffarian, MD, DrPH; Paul M Ridker, MD; Kausik K. Ray, MBChB, MD, MPhil; Brian G. Katona, PharmD; Anders Himmelmann, MD, PhD; Larrye E. Loss, PharmD, MBA; Martin Rensfeldt; Torbjörn Lundström, MD, PhD; Rahul Agrawal, MD; Venu Menon, MD; Kathy Wolski, MPH; Steven E. Nissen, MD



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.


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