Ann. Intern. Med 2013 Dec 17;159(12)797-805, GA Lamas, R Boineau, C Goertz, DB Mark, Y Rosenberg, M Stylianou, T Rozema, RL Nahin, L Lindblad, EF Lewis, J Drisko, KL Lee Research · January 01, 2014

Full Story:  http://www.practiceupdate.com/journalscan/7358
Journal Reference:  http://annals.org/article.aspx?articleid=1789248

TAKE-HOME MESSAGE

• This was a secondary analysis of 1708 patients > age 50 years with history of myocardial infarction (MI) and enrolled in the Trial to Assess Chelation Therapy. After a median of 55 months, use of a high-dose oral multivitamin/multimineral regimen showed no reduction in time to recurrent MI, stroke, revascularization, hospitalization for angina, or death when compared with placebo.
• Although these results do not support the use of high-dose vitamins and minerals for secondary prevention of cardiovascular events, the caveat is the high rate of withdrawal from the study and nonadherence to the intervention.

Commentary By

Douglas P Zipes MD
A recent article in the New York Times (Spike in Harm to Liver Is Tied to Dietary Aids) focused on dietary supplements causing nearly 20% of drug-related liver injuries that are treated in hospitals, up from 7% 10 years ago. The NYT noted that Americans spend $32 billion annually on dietary supplements that promise everything from weight reduction, enhanced energy and muscle mass, to cold cures. These products are essentially untested and unregulated. The toothless Dietary Supplement Health and Education Act enacted in 1994 enables companies almost limitless permission to espouse unproven claims without the usual FDA regulation required for drugs. In fact, it is the FDA that has to prove harm, not the company, before the supplement can be taken off the market. The FDA succeeded in doing this for ephedra-containing products in 2004. The article by Lamas et al drives another nail in the dietary supplement coffin by showing that high-dose multivitamins and multiminerals did not reduce cardiovascular events in patients after myocardial infarction who received standard medications. Practitioners should caution their patients against taking such products without careful analysis first.

ABSTRACT

BACKGROUND

Whether high-dose multivitamins are effective for secondary prevention of atherosclerotic disease is unknown.

OBJECTIVE

To assess whether oral multivitamins reduce cardiovascular events and are safe.

DESIGN

Double-blind, placebo-controlled, 2 × 2 factorial, multicenter, randomized trial.

SETTING

134 U.S. and Canadian academic and clinical sites.

PATIENTS

1708 patients aged 50 years or older who had myocardial infarction (MI) at least 6 weeks earlier and had serum creatinine levels of 176.8 µmol/L (2.0 mg/dL) or less.

INTERVENTION

Patients were randomly assigned to an oral, 28-component, high-dose multivitamin and multimineral mixture or placebo.

MEASUREMENTS

The primary end point was time to total death, recurrent MI, stroke, coronary revascularization, or hospitalization for angina.

RESULTS

The median age was 65 years, and 18% of patients were women. The qualifying MI occurred a median of 4.6 years (interquartile range [IQR], 1.6 to 9.2 years) before enrollment. Median follow-up was 55 months (IQR, 26 to 60 months). Patients received vitamins for a median of 31 months (IQR, 13 to 59 months) in the vitamin group and 35 months (IQR, 13 to 60 months) in the placebo group (P = 0.65). Totals of 645 (76%) and 646 (76%) patients in the vitamin and placebo groups, respectively, completed at least 1 year of oral therapy (P = 0.98), and 400 (47%) and 426 (50%) patients, respectively, completed at least 3 years (P = 0.23). Totals of 394 (46%) and 390 (46%) patients in the vitamin and placebo groups, respectively, discontinued the vitamin regimen (P = 0.67), and 17% of patients withdrew from the study. The primary end point occurred in 230 (27%) patients in the vitamin group and 253 (30%) in the placebo group (hazard ratio, 0.89 [95% CI, 0.75 to 1.07]; P = 0.21). No evidence suggested harm from vitamin therapy in any category of adverse events.

LIMITATION

There was considerable nonadherence and withdrawal, limiting the ability to draw firm conclusions (particularly about safety).

CONCLUSION

High-dose oral multivitamins and multiminerals did not statistically significantly reduce cardiovascular events in patients after MI who received standard medications. However, this conclusion is tempered by the nonadherence rate.