Coronary disease & ACS

Multivitamins After Myocardial Infarction in Patients With Diabetes: A Randomized Clinical Trial

JAMA Intern MedPublished randomized, multicenter double-masked 2 × 2 factorial clinical trial

Primary result · Composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable anginaResult — go to the resultHazard ratio 0.99 95% CI 0.80–1.22

Authors' conclusion

The results of this randomized clinical trial demonstrated that, for participants with chronic coronary disease, diabetes, and a previous MI, high-dose OMVM alone or in conjunction with EDTA-based chelation did not reduce cardiovascular events.

Study context

Population
Participants 50 years or older with diabetes and an myocardial infarction (MI) 6 weeks ago or morerandomized
Participants
1,000 participants
Comparison
OMVM vs placebo
  • Active OMVMn = 500
  • Placebo OMVMn = 500reference
Primary endpoint
Composite of:
  • All-cause mortality
  • MI
  • Stroke
  • Coronary revascularization
  • Hospitalization for unstable angina
Follow-up
Median (IQR) 48 (34-58) months
Methodological details88 sites in the US and Canada, 1:1:1:1 allocation ratio
  • 88 sites in the US and Canada
  • 1:1:1:1 allocation ratio

Primary result

As reported in the abstract

Hazard ratio

0.99

95% CI 0.80–1.22

P = 0.92

Events by treatment group

Active OMVMvs placebo OMVM
HR 0.99 (95% CI 0.80–1.22); P = 0.92

Further findings

OutcomeEDTA chelation + active OMVMEDTA chelation + placebo OMVMPlacebo infusion + active OMVMPlacebo infusion + placebo OMVMHR (95% CI)P value
Primary end point, by factorial group · 5-year event rateActive infusion + active OMVMvs placebo infusion + placebo OMVM34.0%35.7%36.0%34.3%0.91 (0.67–1.23)P = 0.54

MI, stroke, mortality from cardiovascular causes

Nonsignificant, numerically higher event rate in the active OMVM compared to placebo OMVM group

Baseline characteristics

Median (IQR) age
67 (60-72) years
Male
730 (73%)

Original publication

Multivitamins After Myocardial Infarction in Patients With Diabetes: A Randomized Clinical Trial. JAMA Intern Med. Published 1 May 2025. doi:10.1001/jamainternmed.2024.8408

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