4 years ago

Effect of High-Dose Oral Multi-Vitamins and Minerals in Participants Not Treated with Statins in the Randomized Trial to Assess Chelation Therapy

In a pre-specified subgroup analysis of participants not on statin therapy at baseline in the Trial to Assess Chelation Therapy (TACT), a high-dose complex oral multi-vitamins and multi-mineral regimen was found to have a large unexpected benefit compared with placebo. The regimen tested was substantially different from any vitamin regimen tested in prior clinical trials. Objective To explore these results, we performed detailed additional analyses of participants not on statins at enrollment in TACT. Design TACT was a factorial trial testing chelation treatments and a 28-component high-dose oral multi-vitamins and multi-minerals regimen versus placebo in post-myocardial infarction (MI) patients age 50 or greater. Participants There were 460/1708 (27%) TACT participants not taking statins at baseline, 224 (49%) were in the active vitamin group and 236 (51%) were in the placebo group. Setting Patients were enrolled at 134 sites around the US and Canada. Intervention Daily high-dose oral multi-vitamins and multi-minerals (6 tablets, active or placebo). Main Outcome The primary endpoint of TACT was time to the first occurrence of any component of the composite endpoint: all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for angina. Results The primary endpoint occurred in 137 non-statin participants (30%), of which 51/224 (23%) were in the active group and 86/236 (36%) were taking placebo (HR=0.62, 95% CI: 0.44, 0.87, P =.006). Results in the key TACT secondary endpoint, a combination of cardiovascular mortality, stroke, or recurrent MI, was consistent in favoring the active vitamin group (HR=0.46, 95% CI 0.28, 0.75, P =.002). Multiple endpoints analyses were consistent with these results. Conclusion and Relevance High-dose oral multi-vitamin and multi-mineral supplementation appear to decrease combined cardiac events in a stable, post-MI population not taking statin therapy at baseline. These unexpected findings are being retested in the ongoing TACT2.

Publisher URL: www.sciencedirect.com/science

DOI: S0002870317302739

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