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Oral multivitamins and multiminerals (OMVMs) did not reduce cardiovascular events in patients with diabetes and prior myocardial infarction (MI). High-dose OMVMs, alone or with EDTA chelation, showed no benefit in this patient group.

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Area of Science:

  • Cardiovascular Medicine
  • Clinical Trials
  • Nutritional Science

Background:

  • The Trial to Assess Chelation Therapy (TACT) previously investigated oral multivitamins and multiminerals (OMVMs) with EDTA chelation therapy.
  • Prior TACT findings indicated that while OMVMs alone did not reduce cardiovascular events, active EDTA combined with active OMVMs showed superiority over placebo.

Purpose of the Study:

  • To evaluate the efficacy of oral multivitamins and multiminerals (OMVMs) compared to placebo in reducing major adverse cardiovascular events.
  • To assess the effect of OMVMs in patients with diabetes and a history of myocardial infarction (MI).

Main Methods:

  • A randomized, multicenter, double-masked, 2x2 factorial clinical trial (TACT2) involving 1000 participants aged 50 years or older with diabetes and prior MI.
  • Participants received either active OMVMs or placebo OMVMs, and active EDTA chelation or placebo infusions.
  • The primary endpoint was a composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina.

Main Results:

  • No significant difference in the primary endpoint was observed between the active OMVM group and the placebo OMVM group (hazard ratio [HR], 0.99 [95% CI, 0.80-1.22]; P=.92).
  • The combination of EDTA chelation and active OMVMs did not significantly reduce cardiovascular events compared to placebo infusions and placebo OMVMs (HR, 0.91 [95% CI, 0.67-1.23]; P=.54).
  • A numerically higher event rate of MI, stroke, and cardiovascular mortality was observed in the active OMVM group compared to the placebo OMVM group, although this was not statistically significant.

Conclusions:

  • High-dose oral multivitamins and multiminerals (OMVMs), administered alone or in conjunction with EDTA-based chelation, did not demonstrate efficacy in reducing cardiovascular events in patients with chronic coronary disease, diabetes, and a prior myocardial infarction.
  • These findings suggest that OMVMs are not beneficial for preventing major adverse cardiovascular events in this specific high-risk population.