Cora E Lewis1, John P Bantle2, Alain G Bertoni3, George Blackburn4, Frederick L Brancati5, George A Bray6, Lawrence J Cheskin5, Jeffrey M Curtis7, Caitlin Egan8, Mary Evans9, John P Foreyt10, Siran Ghazarian11, Bethany Barone Gibbs12, Stephen P Glasser1, Edward W Gregg13, Helen P Hazuda14, Louise Hesson15, James O Hill16, Edward S Horton17, Van S Hubbard9, John M Jakicic12, Robert W Jeffery2, Karen C Johnson18, Steven E Kahn19, Abbas E Kitabchi18, Dalane Kitzman3, William C Knowler20, Edward Lipkin19, Sara Michaels21, Maria G Montez14, David M Nathan22, Ebenezer Nyenwe18, Jennifer Patricio23, Anne Peters11, Xavier Pi-Sunyer23, Henry Pownall10, David M Reboussin3, Donna H Ryan6, Thomas A Wadden15, Lynne E Wagenknecht3, Holly Wyatt16, Rena R Wing8, Susan Z Yanovski9. 1. University of Alabama at Birmingham, Birmingham, Alabama, USA. 2. University of Minnesota, Minneapolis, Minnesota, USA. 3. Wake Forest University, Winston-Salem, North Carolina, USA. 4. Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. 5. Johns Hopkins University, Baltimore, Maryland, USA. 6. Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA. 7. Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA. 8. The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA. 9. National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA. 10. Baylor College of Medicine, Houston, Texas, USA. 11. University of Southern California, Los Angeles, California, USA. 12. University of Pittsburgh, Pittsburgh, Pennsylvania, USA. 13. Centers for Disease Control and Prevention, Atlanta, Georgia, USA. 14. University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA. 15. University of Pennsylvania, Philadelphia, Pennsylvania, USA. 16. University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA. 17. Joslin Diabetes Center, Boston, Massachusetts, USA. 18. The University of Tennessee Health Science Center, Memphis, Tennessee, USA. 19. US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA. 20. Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona, USA. 21. Southwestern American Indian Center, Shiprock, New Mexico, USA. 22. Massachusetts General Hospital, Boston, Massachusetts, USA. 23. St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.
Abstract
OBJECTIVE: To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]). METHODS: This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes. RESULTS:Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group. CONCLUSIONS: Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design.
RCT Entities:
OBJECTIVE: To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]). METHODS: This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes. RESULTS: Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group. CONCLUSIONS: Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design.
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