首页|Effect of cocoa flavanol supplementation for prevention of cardiovascular disease events: The COSMOS randomized clinical trial
Effect of cocoa flavanol supplementation for prevention of cardiovascular disease events: The COSMOS randomized clinical trial
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NSTL
Elsevier
Background Cocoa extract is a source of flavanols that favorably influence vascular risk factors in small and short-term trials, yet effects on clinical cardiovascular events are untested. Objectives We examined whether cocoa extract supplementation decreases total cardiovascular disease (CVD) among older adults. Methods We conducted a randomized, double-blind, placebo-controlled, two-by-two factorial trial of cocoa extract supplementation and multivitamins for prevention of CVD and cancer among 21,442 U.S. adults (12,666 women aged >= 65 years and 8,776 men aged >= 60 years) free of major CVD and recently diagnosed cancer. Intervention phase was June 2015 through December 2020. This article reports on the cocoa extract intervention. Participants were randomly assigned to a cocoa extract supplement (500 mg/d flavanols, including 80 mg (-)-epicatechins) or placebo. The primary outcome was a composite of confirmed incident total cardiovascular events, including myocardial infarction (MI), stroke, coronary revascularization, cardiovascular death, carotid artery disease, peripheral artery surgery, and unstable angina. Results During a median follow-up of 3.6 years, 410 participants taking cocoa extract and 456 taking placebo had confirmed total cardiovascular events (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.78, 1.02; P = 0.11). For secondary endpoints, HRs were 0.73 (95% CI, 0.54, 0.98) for CVD death, 0.87 (95% CI, 0.66, 1.16) for MI, 0.91 (95% CI, 0.70, 1.17) for stroke, 0.95 (95% CI, 0.77, 1.17) for coronary revascularization, neutral for other individual cardiovascular endpoints, and 0.89 (95% CI, 0.77, 1.03) for all-cause mortality. Per-protocol analyses censoring follow-up at nonadherence supported a lower risk of total cardiovascular events (HR, 0.85; 95% CI, 0.72, 0.99). There were no safety concerns. Conclusion Cocoa extract supplementation did not significantly reduce total cardiovascular events among older adults but reduced CVD death by 27%. Potential reductions in total cardiovascular events were supported in per-protocol analyses. Additional research is warranted to clarify whether cocoa extract may reduce clinical cardiovascular events.
Sesso, Howard D.、Manson, JoAnn E.、Aragaki, Aaron K.、Rist, Pamela M.、Johnson, Lisa G.、Friedenberg, Georgina、Copeland, Trisha、Clar, Allison、Mora, Saima、Moorthy, M. Vinayaga、Sarkissian, Ara、Carrick, William R.、Anderson, Garnet L.、COSMOS Res Grp
NSTL
Elsevier
