Multivitamins After Myocardial Infarction in Patients With Diabetes: A Randomized Clinical Trial
Primary result · Primary composite end pointResult — go to the resultHazard ratio 0.99 95% CI 0.80–1.22Authors' 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
- Patients aged ≥50 years with diabetes and myocardial infarction (MI) ≥6 weeks earlier, 88 sites in the US and Canada; median (IQR) age 67 (60–72) years, 73% malerandomized 1:1:1:1
- Participants
- 1,000 patients
- Comparison
- Oral multivitamins and multiminerals vs placebo OMVM
- Active OMVMn = 500
- Placebon = 500reference
- Primary endpoint
- Composite of:
- All-cause mortality
- MI
- Stroke
- Coronary revascularization
- Hospitalization for unstable angina
Methodological detailsmulticenter, double-masked, 2 × 2 factorial, Enrolled September 2016–December 2020; data collected October 2016–June 2023
- Multicenter
- Double-masked
- 2 × 2 factorial
- Enrolled September 2016–December 2020; data collected October 2016–June 2023
Primary result
Primary composite end point · median follow-up 48 (IQR 34-58) months
Hazard ratio
0.99
95% CI 0.80–1.22
P = 0.92
Events by treatment group
Active OMVMvs Placebo
HR 0.99 (95% CI 0.80–1.22); P = 0.92
As reported in the abstract
Further findings
| Outcome | EDTA chelation + active OMVM | EDTA chelation + placebo OMVM | Placebo infusion + active OMVM | Placebo infusion + placebo OMVM | HR (95% CI) | P value | |
|---|---|---|---|---|---|---|---|
| Primary end point by factorial group, 5-year event rate · 5 yearsEDTA chelation + active OMVMvs Placebo infusion + placebo OMVM | 34.0% | 35.7% | 36.0% | 34.3% | 0.91 (0.67–1.23) | P = 0.54 | |
| 0.512Hazard ratio (log scale) |
MI, stroke, CV mortality
- Numerically higher, nonsignificant event rate with active OMVM vs placebo OMVM
Original publication
Multivitamins After Myocardial Infarction in Patients With Diabetes: A Randomized Clinical Trial. JAMA Intern Med. Published 1 May 2025. doi:10.
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