Multivitamins After Myocardial Infarction in Patients With Diabetes
Authors: Francisco Ujueta, Gervasio A. Lamas, Kevin J. Anstrom, Ana Navas-Acien, Robin Boineau, Yves Rosenberg, Mario Stylianou, Teresa L. Z. Jones, Bonnie R. Joubert, Qilu Yu, Jun Wen, Hayley Nemeth, Zhen Huang, Vivian Fonseca, David M. Nathan, Gabriel Uwaifo, Ivan A. Arenas, Lan Luo, Jeffrey Baker, Diana Visentin, Andre Paixao, John F. Schmedtje, Daniel B. Mark, Philip Bear, Donna Prouty, Jodi Baxter, Jonathan Ehrman, Heather Golden, Vikrant Katoch, Raffi Krikorian, Andre Paixao, Fujiko Anazawa, Leybi Ramirez-Kelly, Abby Nolen, Venus Barney, Gerald Natzke, Rodica Pop-Busui, Cindy Plunkett, Laura Meyer, James Roberts, Scott Rollins, Tamra Hollis, Nampalli Vijay, Melinda Washam, David Zidar, Terence Semenec, Lauren Huntington, Amanda Klumpp, Matthew Scott Doughty, Jeffrey Baker, Joseph Allen, Rebecca Cortez, Bhaskar Purushottam, Kirstin Stauffacher, Kelly Airey, Elena Christofides, Jordyn Conway, David Hoffman, Patty Schuler, Ronald Solbrig, Loni Chacon, Phillip Levy, Linda Gojcevic, Roy Collins, John Miles McClure II, Ellen Mook, Christopher DeFilippi, Wendy Sheaffer, Antoinette Bonaccorso, Daniel Donovan, Julee Hartwell, Andrew Garner, Dawn Kalbfliesh, David Hsi, Maryanne Ducey, Paula Trump, Urs Leuenberger, Katie Loffredo, Betty Persico, Allan Magaziner, Dennis Goodman, Michela Garabedian, Jane Coates, Jeanne Wingo, Sheldon Gottlieb, Michael Schachter, Sally Minniefield, Olakunle Akinboboye, Kazi Ullah, Karen Wolske, Dennis Friedman, Daniel Lorber, Mari Tsovian, Regina Druz, Patricia Hodnett, Stephanie Meller, Maria Bartolome, Giselle Cortez Vargas, Ian Ergui, Francisco Ujueta, Priscilla Valls, Marnie Lozada, Raul Blanco, Ivan Arenas, Esteban Escolar, Xiaoou Pan, Ilana Seidel, Melisa Corado-Williams, Ana Lamas, Mariana Viera-Navarro, Miguel Trevino, Kimberly Mai, Rachel Eidelman, Gabriela Reyes, Kelly Brown, Ricardo Yaryura, Amy Little, Heber Varela, Malu Bienes, Robert Jeanfreau, Paul Neff, Mark Thompson, Melody Lineberger-Moore, Donna Miller, Rakesh Prashad, John Schmedtje Jr, Melissa Shelton, Charles Treasure II, Ashley Freel, Gerardo Rojas, Damaris Bruceles, Gabriel Uwaifo, Veronica Hixon- Calliet, Amber Passini, Stacey Melton, Denise Moreno, Antonio Blanco, Anisia Otero, Mayra Rodriguez, Felix Sogade, Simisola Oludare, Vivian Fonseca, Cynthia Moreau, Sofia Marquez, Phillip Duncan, Unice Davis, Steven Tang, Bonnie DeMuth, Donovan Christie, Lorin Roberts, Amanda Martin, Lan Luo, Summer Waddle, Shameka Brown, Salvatore Bianco, Helmut Steinberg, Amy Bell, Dharmendra Patel, Alison Bailey, Michelle Rice, David Herrington, Karen Blinson, Lynda Doomy, David Smith, Jenny Norton, Suvi Gross, Assad Mouhaffel, Clinton Guillory, Samantha Korn, Yamil Wady Aude, Yirsa Esparza, Sonia Leal, Leidy Abreu, Eric Auerbach, Cindy Huff, Miriam Brooks, Marina Johnson, Tammy Allen, Arthur Berkson, Krystal McAuliffe, Holly Little, Raymond Little, Jalal Abbas, Christina Collard, Jamie Foreman, Shelby Richardson, Andre Desire, Ayham Shneker, Omar Cordero, Piotr Kunik, Radoslav Kiesz, Kathy Sasser, Patrick Golden, Renee Garden, Allen Green, Gordon Fung, Keith Uyemura, Sajad Hamal, Matthew Budoff, Dinh Dinh, Jenny Nguyen, Ashwini Erande, Kelly Brink, Shaista Malik, Nicolas Chronos, Nicole Maslanka, Philip O'Donnell, Margaret Ann Bittorf, Rajesh Garg, Della Matheson, Aldo Martinez, Yasiel Hernandez, Walter Herbert Haught, Lisa Eskridge, Naseem Jaffrani, Melissa Trimble, James (Jamie) Powell, Winifred Bryant, Nakeydia Bryant, Shmuel Bergman, Rezelle Libuit, Angelica Bringas, Diana Visentin, Lori Murphy, Adrienne Junek, Shadi Nahas, Joseph Berlingieri, Caroline Urso, Alireza Moshiri, Thomas Elliott, Marla Inducil, Wanda Parker, Ryan Stults, Hwasoon Kim, Beatriz Acevedo, Nancy LoIacono
Journal: JAMA Internal Medicine (2025)

Importance In 2013, the Trial to Assess Chelation Therapy (TACT) reported that in 1708 patients with stable coronary disease and prior myocardial infarction (MI), oral multivitamins and multiminerals (OMVMs), in a factorial design with edetate disodium (EDTA) chelation therapy, did not reduce cardiovascular events relative to placebo OMVMs, but active EDTA combined with active OMVMs was superior to placebo OMVM/placebo EDTA. Objective To compare OMVM vs placebo in terms of efficacy for reducing major adverse cardiovascular events in patients with diabetes and prior MI. Design, Setting, and Participants The TACT2 randomized, multicenter double-masked 2 × 2 factorial clinical trial took place across 88 sites in the US and Canada. Participants were 50 years or older, had diabetes, and had an MI 6 weeks ago or more. TACT2 participants were enrolled between September 2016 and December 2020. Data were collected between October 2016 and June 2023. Interventions Six caplets daily of a 28 component OMVM or matching OMVM placebo, and 40 weekly infusions of an EDTA-based chelation solution or matching placebo, in a 1:1:1:1 allocation ratio. Main Outcomes and Measures The primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. Results A total of 1000 participants were randomized (500 in the active OMVM group and 500 in the placebo group). The median (IQR) age was 67 (60-72) years, and 730 (73%) were male. Median (IQR) follow-up was 48 (34-58) months. The primary end point occurred in 175 participants (35%) in the active OMVM group and 175 (35%) in the placebo group (hazard ratio [HR], 0.99 [95% CI, 0.80-1.22]; P = .92). The 5-year event rate for the primary end point in the EDTA chelation + active OMVM group was 34.0%; in the EDTA chelation + placebo OMVM group, 35.7%; in the placebo infusion + active OMVM group, 36.0%; and in the placebo infusion + placebo OMVM group, 34.3%. The comparison of the active infusion + active OMVM with the placebo infusion + placebo OMVM was not significant (HR, 0.91 [95% CI, 0.67-1.23]; P = .54). Although nonsignificant, there was a numerically higher event rate of MI, stroke, mortality from cardiovascular causes in the active OMVM compared to placebo OMVM group. Conclusions and Relevance The results of this randomized clinical trial demonstrated that, for participants with chronic coronary disease, diabetes, and a previous MI, high-dose OMVM alone or in conjunction with EDTA-based chelation did not reduce cardiovascular events. Trial Registration ClinicalTrials.gov Identifier: NCT02733185