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TACT: High-dose vitamins plus chelation therapy may be beneficial
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SAN FRANCISCO — A combination of high-dose oral vitamins and minerals did not significantly reduce recurrent cardiac events for patients with a prior MI.
However, one component of the TACT study demonstrated that high-dose vitamins and minerals, in combination with active chelation therapy, may provide some additional benefit in this patient population.
The study tested the safety and effectiveness of ethylene diamine tetra-acetic chelation therapy and high-dose vitamin/mineral supplements in 1,708 patients with prior MIs. In the 2x2 factorial trial, patients were randomly assigned to four study groups:
- active oral vitamins plus active chelation therapy;
- placebo oral vitamins plus active chelation therapy;
- active oral vitamins plus placebo infusions; or
- placebo oral vitamins plus placebo infusions.
Patients received 40 intravenous chelation treatments, or placebo, each lasting about 3 hours during a year and a half. They were also assigned to take three pills twice daily, containing either high-dose vitamins and minerals or placebo, according to a press release. The active vitamins were a 28-component mixture, according to the researchers. Patients were followed for a mean of 55 months.
At a late-breaking clinical trials session, Gervasio A. Lamas, MD, chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla., said the researchers found no significant difference in the primary endpoint — a composite of recurrent MI, stroke, coronary revascularization, hospitalization, angina and death. The primary endpoint was 34% in the vitamin/mineral group vs. 37% in the placebo group. Analysis of the four study groups showed vitamins plus chelation therapy significantly reduced risk for the primary endpoint when compared with placebo/placebo (HR=0.74; 95% CI, 0.57-0.95).
Gervasio A. Lamas
“We did not see a significant benefit of vitamins alone for patients who had a MI,” Lamas stated in the press release. “Patients who received both high-dose vitamins and active chelation compared to placebo of both appeared to have additional benefit, but more research is needed to understand the results.”
About half of the patients enrolled in the trial stopped taking the vitamins or minerals during the study follow-up; researchers said patient preference was the primary reason.
“The message here is really a cautious one. We’ve moved something that has been an alternative medicine treatment into the realm of scientific inquiry and found some other results that merit further research. We don’t think the results of any single trial are enough to carry this novel hypothesis into daily use for patients who have acute MI,” Lamas said during a press conference.
Results of the TACT study were presented in November at the American Heart Association Scientific Sessions suggesting that chelation therapy, with or without supplements, provided a modest reduction in cardiac events as compared with placebo.
The double blind, controlled trial was conducted at 134 sites in the United States and Canada from 2002 to 2011. All patients were aged 50 years or older and had a MI at least 6 months prior to enrollment. Eighty-two percent of patients were men, 94% white and about half were obese. Thirty-two percent had diabetes, 68% had hypertension and 83% had previously undergone bypass surgery, stent implantation or balloon angioplasty. At baseline, many patients were already taking evidence-based medications: 84% aspirin, 72% beta-blockers and 73% statins.
– by Katie Kalvaitis
For more information:
Lamas GA. Late-breaking clinical trials III: Chronic CAD/stable ischemic heart disease and acute coronary syndromes. Presented at: American College of Cardiology Scientific Session; March 9-11, 2013; San Francisco.
Disclosure: Lamas reports no relevant financial disclosures.
Perspective
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Neal S. Kleiman, MD, FACC
Surprising to me was a very high noncompliance rate. I think if you ask any clinician, getting a patient to stop taking vitamins they bought as supplements is only slightly easier than getting them to lose weight and stop smoking.
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