You’re doing WHAT??

By: Lisa Moynihan   
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So my father informed me this past weekend that he was participating in a research study that involves an infusion a week for 40 weeks.  You’re doing WHAT??” I exclaimed!  For what?  Where?  What doctor?  Does he know what medications you’re on?  Did you sign anything? And my inquiries went on.

Unfortunately, my father had very little information to offer.  I was disappointed in both him (How could he not know more??) and his cardiologist (Does this doctor realize how ill informed his patient is?).

I immediately did some research.

Long story short my 69 year old, diabetic father is participating in a Phase 3 clinical research trial called TACT2, Trial to Assess Chelation Therapy. According to clinicaltrials.gov there are over 100 clinical research sites in the U.S. and Canada aiming to enroll 1,200 diabetic patients 50- years of age or older who have survived a prior heart attack.

I learned EDTA chelation is a therapy by which repeated administrations of a weak synthetic amino acid gradually reduces atherosclerotic plaque and other mineral deposits throughout the cardiovascular system by dissolving them.

TACT2 follows up on the positive results of TACT, an NIH-sponsored multicenter, double-blind safety and efficacy study, which took place from 2002- 2012. Approximately 2,000 heart attack patients were randomly assigned to receive 40 infusions of disodium EDTA or placebo plus an oral vitamin and mineral regimen, or an oral placebo.

TACT demonstrated an 18 percent reduction in recurrent heart events by chelation in patients who already had sustained a heart attack.  Recurrent heart events measured in the study were death, heart attack, stroke, heart bypass or stent, and hospitalization for angina.

In 633 diabetic patients, there was an even larger benefit with a 41 percent reduction in recurrent heart events and a 43 percent reduction in deaths. Based on these results, the Mount Sinai and Duke scientists who conducted the trial felt that a repeat study was important to carry out.

Disodium EDTA is thought to bind toxic metals in the body, including lead and cadmium that may contribute to the development of heart disease. The FDA approved EDTA use to bind metal ions for treating mercury and lead poisoning back in 1953. It has been used since by dentists, cosmetic companies and for various laboratory applications.

Although not approved by the FDA for treating heart disease, some practitioners have used chelation therapy as an “alternative medicine” for nearly 60 years in the absence of clinical trial data supporting its use.  Because of the lack of data, it has generally been believed by conventional medical practitioners and cardiologists to be without value, although TACT results suggest otherwise. A definitive answer on chelation therapy in diabetic patients that will be embraced by the cardiology community will require positive results from TACT2.

You’re doing WHAT??
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Lisa Moynihan
Our newest member of the editorial team, Lisa joined MLO in early 2015. She brings to the table over 15 years of pharmaceutical advertising management. Her industry experience includes developing marketing and educational campaigns for clinical research studies for both physicians and patients. Lisa is also a regular blogger, published freelance writer and social media guru.

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