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Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).

Publication ,  Journal Article
Issa, OM; Roberts, R; Mark, DB; Boineau, R; Goertz, C; Rosenberg, Y; Lewis, EF; Guarneri, E; Drisko, J; Magaziner, A; Lee, KL; Lamas, GA
Published in: Am Heart J
January 2018

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.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

January 2018

Volume

195

Start / End Page

70 / 77

Location

United States

Related Subject Headings

  • Vitamins
  • Treatment Outcome
  • Time Factors
  • Retrospective Studies
  • Myocardial Infarction
  • Minerals
  • Middle Aged
  • Male
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
 

Citation

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Issa, O. M., Roberts, R., Mark, D. B., Boineau, R., Goertz, C., Rosenberg, Y., … Lamas, G. A. (2018). Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT). Am Heart J, 195, 70–77. https://doi.org/10.1016/j.ahj.2017.09.002
Issa, Omar M., Rhonda Roberts, Daniel B. Mark, Robin Boineau, Christine Goertz, Yves Rosenberg, Eldrin F. Lewis, et al. “Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).Am Heart J 195 (January 2018): 70–77. https://doi.org/10.1016/j.ahj.2017.09.002.
Issa OM, Roberts R, Mark DB, Boineau R, Goertz C, Rosenberg Y, et al. Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT). Am Heart J. 2018 Jan;195:70–7.
Issa, Omar M., et al. “Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).Am Heart J, vol. 195, Jan. 2018, pp. 70–77. Pubmed, doi:10.1016/j.ahj.2017.09.002.
Issa OM, Roberts R, Mark DB, Boineau R, Goertz C, Rosenberg Y, Lewis EF, Guarneri E, Drisko J, Magaziner A, Lee KL, Lamas GA. Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT). Am Heart J. 2018 Jan;195:70–77.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

January 2018

Volume

195

Start / End Page

70 / 77

Location

United States

Related Subject Headings

  • Vitamins
  • Treatment Outcome
  • Time Factors
  • Retrospective Studies
  • Myocardial Infarction
  • Minerals
  • Middle Aged
  • Male
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans