Gervasio A. Lamas, MD; Robin Boineau, MD, MA; Christine Goertz, DC, PhD; Daniel B. Mark, MD, MPH; Yves Rosenberg, MD; Mario Stylianou, PhD; Theodore Rozema, MD; Richard L. Nahin, PhD, MPH; Lauren Lindblad, MS; Eldrin F. Lewis, MD; Jeanne Drisko, MD; Kerry L. Lee, PhD; for the TACT (Trial to Assess Chelation Therapy) Investigators (*)
Note: Dr. Lamas had full access to all of the data in the study and had final responsibility for the decision to submit this article for publication.
Disclaimer: The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Heart, Lung, and Blood Institute; National Center for Complementary and Alternative Medicine; or National Institutes of Health.
Acknowledgment: The authors thank the TACT investigators (members are listed in the Appendix). They also thank Ana Mon, MPH, Project Leader at the Clinical Coordinating Center, for her organizational skills; Alyssa Cotler at the National Center for Complementary and Alternative Medicine, Susan Dambrauskas (formerly at the National Heart, Lung, and Blood Institute), and Vivian Thompson at the Duke Clinical Research Institute for their competent professional assistance; and the Florida Heart Research Institute for supporting the pilot study.
Grant Support: Grant U01HL092607 from the National Heart, Lung, and Blood Institute and grant U01AT001156 from the National Center for Complementary and Alternative Medicine of the National Institutes of Health.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-1530.
Reproducible Research Statement: Study protocol, statistical code, and data set: Not available.
Requests for Single Reprints: Gervasio A. Lamas, MD, Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL 33140; e-mail, email@example.com.
Current Author Addresses: Dr. Lamas: Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL 33140.
Drs. Boineau, Rosenberg, and Stylianou: National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, MSC 7956, Bethesda, MD 20892.
Dr. Goertz: Palmer Center for Chiropractic Research, 741 Brady Street, Davenport, IA 52804.
Drs. Mark and Lee and Ms. Lindblad: Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27705.
Dr. Rozema: Biogenesis Medical Center, 1000 East Rutherford Road, Landrum, SC 29356.
Dr. Nahin: National Center for Complementary and Alternative Medicine, 31 Center Drive, Room 2 B-11, Bethesda, MD 20892.
Dr. Lewis: Brigham and Women's Hospital and Harvard Medical School, 75 Francis Street, Boston, MA 02115.
Dr. Drisko: Integrative Medicine, University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 1017, Kansas City, KS 66160.
Author Contributions: Conception and design: G.A. Lamas, R. Boineau, C. Goertz, D.B. Mark, Y. Rosenberg, M. Stylianou, T. Rozema, R.L. Nahin, E.F. Lewis, J. Drisko, K.L. Lee.
Analysis and interpretation of the data: G.A. Lamas, R. Boineau, D.B. Mark, Y. Rosenberg, M. Stylianou, R.L. Nahin, L. Lindblad, E.F. Lewis, J. Drisko, K.L. Lee.
Drafting of the article: G.A. Lamas, R. Boineau, C. Goertz, M. Stylianou, L. Lindblad, J. Drisko, K.L. Lee.
Critical revision of the article for important intellectual content: G.A. Lamas, R. Boineau, D.B. Mark, Y. Rosenberg, M. Stylianou, R.L. Nahin, L. Lindblad, E.F. Lewis, J. Drisko, K.L. Lee.
Final approval of the article: G.A. Lamas, R. Boineau, C. Goertz, D.B. Mark, Y. Rosenberg, M. Stylianou, R.L. Nahin, L. Lindblad, E.F. Lewis, J. Drisko, K.L. Lee.
Provision of study materials or patients: G.A. Lamas, J. Drisko.
Statistical expertise: M. Stylianou, L. Lindblad, K.L. Lee.
Obtaining of funding: G.A. Lamas, R. Boineau, D.B. Mark.
Administrative, technical, or logistic support: G.A. Lamas, R. Boineau, Y. Rosenberg, T. Rozema.
Collection and assembly of data: D.B. Mark, E.F. Lewis, J. Drisko.
Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, et al. Oral High-Dose Multivitamins and Minerals After Myocardial Infarction: A Randomized Trial. Ann Intern Med. 2013;159:797-805. doi: 10.7326/0003-4819-159-12-201312170-00004
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Published: Ann Intern Med. 2013;159(12):797-805.
Whether high-dose multivitamins are effective for secondary prevention of atherosclerotic disease is unknown.
To assess whether oral multivitamins reduce cardiovascular events and are safe.
Double-blind, placebo-controlled, 2 × 2 factorial, multicenter, randomized trial. (ClinicalTrials.gov: NCT00044213)
134 U.S. and Canadian academic and clinical sites.
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.
Patients were randomly assigned to an oral, 28-component, high-dose multivitamin and multimineral mixture or placebo.
The primary end point was time to total death, recurrent MI, stroke, coronary revascularization, or hospitalization for angina.
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.
There was considerable nonadherence and withdrawal, limiting the ability to draw firm conclusions (particularly about safety).
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.
National Institutes of Health.
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Cardiology, Emergency Medicine, Acute Coronary Syndromes, Coronary Heart Disease.
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