1. Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).
- Author
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Issa OM, Roberts R, Mark DB, Boineau R, Goertz C, Rosenberg Y, Lewis EF, Guarneri E, Drisko J, Magaziner A, Lee KL, and Lamas GA
- Subjects
- Administration, Oral, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Retrospective Studies, Time Factors, Treatment Outcome, Chelation Therapy methods, Hydroxymethylglutaryl-CoA Reductase Inhibitors administration & dosage, Minerals administration & dosage, Myocardial Infarction drug therapy, Vitamins administration & dosage
- Abstract
Importance: In a prespecified subgroup analysis of participants not on statin therapy at baseline in the TACT, a high-dose complex oral multivitamins and multimineral 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 multivitamins and multiminerals regimen versus placebo in post-myocardial infarction (MI) patients 50 years or older., Participants: There were 460 (27%) of 1,708 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 United States and Canada., Intervention: Daily high-dose oral multivitamins and multiminerals (6 tablets, active or placebo)., Main Outcome: The primary end point of TACT was time to the first occurrence of any component of the composite end point: all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for angina., Results: The primary end point occurred in 137 nonstatin participants (30%), of which 51 (23%) of 224 were in the active group and 86 (36%) of 236 were taking placebo (hazard ratio, 0.62; 95% confidence interval, 0.44-0.87; P=.006). Results in the key TACT secondary end point, a combination of cardiovascular mortality, stroke, or recurrent MI, was consistent in favoring the active vitamin group (hazard ratio, 0.46; 95% confidence interval, 0.28-0.75; P=.002). Multiple end point analyses were consistent with these results., Conclusion and Relevance: High-dose oral multivitamin and multimineral supplementation seem 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., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
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