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Cardiology Patient Page Chelation Therapy A New Look at an Old Treatment for Heart Disease, Particularly in Diabetics Gervasio A. Lamas, MD D on’t cringe when you hear the term chelation (key-LAY-shun) therapy. If you have heard about it at all, you may have heard that it is alternative medicine, quackery, expensive, and even dangerous. New research funded by the National Institutes of Health is suggesting that this old treatment has some real life in it and that it may particularly benefit patients with diabetes mellitus and prior heart attacks. What Is Chelation Therapy? Chelation therapy was first used in the early 20th century to treat metal poisoning. The treatment involves administering a drug called a chelator, which has a magnetically charged pocket that can “grab” a metal and hang onto it, kind of like a baseball mitt with a magnet in its pocket, allowing the metal to be excreted in the urine. One chelator, calcium ethylenediaminetetraacetic acid (EDTA), is approved by the US Food and Drug Administration to treat lead poisoning. Alternative medicine practitioners have been using a similar chelator, disodium EDTA, to treat heart disease, claiming to see benefits, since the 1950s. Disodium EDTA chelation therapy is usually administered intravenously each week for 20 to 40 sessions. Each intravenous infusion may last hours. In spite of the expense and tedium, the 2008 National Health Statistics Report stated that 111 000 people used chelation in 2007. What Does My Doctor Think About Chelation? Major cardiology organizations have published statements discouraging the use of chelation. These opinions were formed in the 1960s and 1970s, when the doses and rates of administration of EDTA chelation had not been standardized, and there were safety problems, including kidney problems and even deaths. These opinions were so strong that until 2002 no large-scale, clinical trial had been funded that could determine whether EDTA chelation harmed or benefitted cardiac patients. So What Is New About Chelation in 2015? There are reasons to think that chelation to remove metals might treat or prevent heart disease.1 Some complications of diabetes mellitus may be caused by chemical reactions that happen to the excess sugar in the blood. These reactions are catalyzed, or facilitated, by metals. The environment is polluted with metals that are toxic to our systems. Lead (gasoline, plumbing), arsenic (well water, rice, apple juice), mercury (many fish), and cadmium (from rechargeable batteries) are among the top 10 most toxic substances listed by the US government. EDTA chelates lead and cadmium. Concurrent with these conceptual developments and because of the large number of Americans receiving chelation therapy, in 2002, the National Center for Complementary and Alternative Medicine and the National Heart, Lung, and Blood Institute funded a $30 million clinical trial of chelation therapy in patients 50 years of age or older with a prior The information contained in this Circulation Cardiology Patient Page is not a substitute for medical advice, and the American Heart Association recommends consultation with your doctor or healthcare professional. From Columbia University Division of Cardiology, Mount Sinai Medical Center, Miami Beach, FL. Correspondence to Gervasio A. Lamas, MD, FAHA, Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Rd, Ste 2070A, Miami Beach, FL 33140. E-mail [email protected] (Circulation. 2015;131:e505-e506. DOI: 10.1161/CIRCULATIONAHA.114.010774.) © 2015 American Heart Association, Inc. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCULATIONAHA.114.010774 Downloaded from http://circ.ahajournals.org/ by guest on May 26, 2015 e505 e506 Circulation May 26, 2015 hospitalization for heart pains) by EDTA infusions above and beyond that provided by our effective treatments, including statins and aspirin.2 When the group who took the EDTA infusions plus oral vitamins was analyzed, the reduction was 26% compared with placebo.3 The effect was even more striking in patients with diabetes mellitus, in whom there was a 41% reduction in clinical events (Figure), including a 43% reduction in deaths over 5 years.4 There is nothing comparable in diabetes therapies. heart attack and good kidney function to finally understand whether EDTA chelation for coronary disease was safe and effective. So, the Trial to Assess Chelation Therapy (TACT) was born. TACT enrolled 1708 patients who were at least 50 years old and had had a prior heart attack. The proposed treatment was intensive: 40 intravenous infusions, 3 hours each, all given over a little more than a year. Half of the patients received EDTA chelation; the other half received a saltwater placebo. Overall, patients received 55 222 intravenous infusions in 134 offices and hospitals across the United States and Canada. Nearly a decade later, on August 15, 2012, we learned the results of our work. Did chelation work to reduce heart events in a vulnerable population with a prior heart attack? It turns out that it did. And it was safe. I Had a Heart Attack and I Have Diabetes Mellitus; Should I Receive Chelation? The landscape for chelation therapy has changed, and environmental toxins may emerge as a modifiable risk factor for heart disease. The US Food and Drug Administration reviewed the TACT in a positive light but encouraged us to carry out another study to confirm these results (TACT2 is being planned). The American Heart Association, in its latest guidelines, has upgraded chelation Results of TACT Overall, there was an 18% reduction in heart events (death, another heart attack, stroke, stenting or bypass, and TACT EDTA:Placebo Hazard Ratio 95% CI P-value (log-rank) 0.59 0.44, 0.79 .0002 Adj. 0.39, 0.88 .002 Event Rate Placebo EDTA Chelation 0.3 0.2 0.1 0.0 6 12 18 24 30 36 42 48 54 157 116 126 94 60 Months since randomization Number at Risk EDTA Chelation Placebo 322 311 286 270 262 235 243 214 217 187 198 168 Disclosures References 0.4 0 Sources of Funding The National Heart, Lung, and Blood Institute and the National Center for Complementary and Integrative Health provided funding and oversight (grants U01AT001156 and U01HL092607). None. Kaplan-Meier Estimates of the Primary Composite Endpoint EDTA Chelation Therapy vs. Placebo Subset of Patients with Diabetes: Hx, Med Use or Baseline Glucose>=126 0.5 from Class III (never ever do) to Class IIb (probably not effective). So, the “official” answer is no. However, this is an emerging technology, and I believe our data. Clinicians sometimes race ahead of official guidelines. When asked, I recommend that patients seek their doctor’s advice after their doctor has read the TACT articles referenced here. If patients with diabetes mellitus and a prior heart attack want chelation, I do not discourage them like I used to. And for high-risk patients in hospitals that offer chelation as a therapeutic choice like mine, I recommend it. Finally, if your hospital is participating in the upcoming TACT2, currently in the very early planning phase, please get involved in the research. We still have a lot to learn. 187 155 177 134 74 63 Figure. Risk of death, heart attack, stroke, stenting, bypass, or hospitalization for angina in patients with or without chelation therapy. CI indicates confidence interval; and EDTA, ethylenediaminetetraacetic acid. Reproduced from Escolar et al.4 1.Solenkova NV, Newman JD, Berger JS, Thurston G, Hochman JS, Lamas GA. Metal pollutants and cardiovascular disease: mechanisms and consequences of exposure. Am Heart J. 2014;168:812–822. doi: 10.1016/j. ahj.2014.07.007. 2. Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT Investigators. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013;309:1241–1250. doi: 10.1001/jama.2013.2107. 3.Lamas G, Boineau R, Goertz C, Mark DB Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Chappell LT, Lindblad L, Lewis EF, Drisko J, Lee KL. EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: the factorial group results of the Trial to Assess Chelation Therapy. Am Heart J. 2014;168:37–44. 4. Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTAbased chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014;7:15–24. doi: 10.1161/CIRCOUTCOMES.113.000663. Downloaded from http://circ.ahajournals.org/ by guest on May 26, 2015 Chelation Therapy: A New Look at an Old Treatment for Heart Disease, Particularly in Diabetics Gervasio A. Lamas Circulation. 2015;131:e505-e506 doi: 10.1161/CIRCULATIONAHA.114.010774 Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2015 American Heart Association, Inc. All rights reserved. Print ISSN: 0009-7322. 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