'Promising Signals' With Cocoa Flavanols to Reduce CV Events
The researchers initiated the COSMOS study, a pragmatic, large-scale, 2x2 factorial randomized trial testing a cocoa extract supplement (500 mg/day of cocoa flavanols) and a typical multivitamin in the prevention of CVD and cancer among older adults (n = 21,442: 12,666 women aged 65 years and 9776 men aged 60 years who were free of MI, stroke, and recently diagnosed cancer at study entry). This current study focused on the cocoa extract component of the trial.

Participants were divided into four arms in equal proportions:
#Active cocoa extract and active multivitamin
#Active cocoa extract and multivitamin placebo
#Active multivitamin and cocoa extract placebo
#Both placebos

During the intervention period, 866 participants experienced the primary outcome of total cardiovascular events, 410 in the cocoa extract group and 456 in the placebo group (hazard ratio [HR], 0.90; 95% CI, 0.78 – 1.02; P = .11), and 3.5% of participants (n = 750) died.

The annualized rates of total cardiovascular events were 1.08% and 1.20% in the active and placebo cocoa extract groups, respectively — a difference that was not statistically significant. Among secondary outcomes, notably, CVD death was significantly reduced (HR, 0.73; 0.54 – 0.99). However, there were no significant reductions in MI, stroke, and revascularizations in the cocoa vs the placebo group (HR, 0.87; 95% CI, 0.66 – 1.16; HR, 0.91; 95% CI, 0.77 – 1.17; and HR, 0.95; 95% CI, 0.77 – 1.17, respectively). The HR for all-cause mortality was 0.89 (95% CI, 0.77 – 1.03).

Compliance, defined as missing 8 days/month of study pills, remained high throughout the study period in both active cocoa extract and placebo groups, at 83.1% and 84.2%, respectively

Source: https://www.medscape.com/viewarticle/971974?src=rss