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NIH Report: EDTA Chelation Therapy Modestly Reduces Cardiovascular Events

Alternative medicine not approved for heart disease in U.S. (Mar. 26)

Chelation therapy, an unproven alternative medicine in the treatment of heart disease, modestly reduced cardiovascular events in adults aged 50 years and older who had experienced a prior heart attack, according to new research supported by the National Institutes of Health (NIH).

Results from the chelation arm of the Trial to Assess Chelation Therapy (TACT), which were published in the March 27 issue of JAMA, showed that infusions of a form of chelation therapy using disodium ethylene diamine tetra-acetic acid (EDTA) reduced cardiovascular events by 18% compared with placebo. The investigators stated that more research is needed before clinicians can consider routine use of chelation therapy for all heart attack patients. The EDTA-based chelation solution also contained high doses of vitamin C, B vitamins, and other components.

Between 2002 and 2007, the use of chelation therapy to treat heart disease and other diseases grew in the U.S. by nearly 68% to 111,000 people, according to the 2008 National Health Statistics Report. Chelation therapy removes heavy metals and minerals — such as lead, iron, copper, and calcium — from the blood. Disodium EDTA is not approved by the FDA to treat heart disease, the leading cause of death for both men and women in the U.S.

“This study sheds light on a scientific controversy that has previously been untested,” said Gary H. Gibbons, MD, Director of the NIH’s National Heart, Lung, and Blood Institute (NHLBI). “We now know more about the safety and efficacy of this therapy than we did before the study. Further research is needed to fully understand these results before this treatment can be applied to the routine clinical care of heart attack patients. We do not yet know whether this therapy can be applied to most people with heart disease, which patients may potentially benefit from it, or how it may work.”

From 2003 to 2010, the TACT investigators enrolled 1,708 adults aged 50 years and older in the U.S. and Canada. Study participants had suffered a heart attack 6 weeks or more before enrollment (average: 4.5 years). They were randomly assigned to receive 40 infusions of either the disodium EDTA chelation solution or a placebo solution. The patients also were randomly assigned to receive high doses of oral vitamins and minerals or an identical oral placebo. In addition, most of the participants were treated with standard medicines for heart attack survivors, such as aspirin, beta blockers, and statins. The patients were followed for a minimum of 1 year and up to 5 years, with follow-up ending in October 2011.

The study assessed a composite primary endpoint that included death, recurrent heart attack, stroke, hospitalization for angina, and coronary revascularization. The TACT investigators reported a clinically modest, but statistically significant, benefit of chelation therapy compared with placebo infusions. Fewer participants in the chelation group (26%) experienced cardiovascular events than did participants in the placebo group (30%). The study was not designed to include enough patients to detect a difference in mortality.

Some subgroups of study participants appeared to receive particular benefit from chelation therapy, specifically adults with diabetes, who constituted almost a third of the study population.

The TACT study was not designed to discover how or why chelation might benefit heart attack patients, which limits the potential clinical application of these results.

Source: NIH; March 26, 2013.

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