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History of Cardiovascular Disease, Intensive Lifestyle Intervention, and Cardiovascular Outcomes in the Look AHEAD Trial
Author(s) -
Lewis Cora E.,
Bantle John P.,
Bertoni Alain G.,
Blackburn George,
Brancati Frederick L.,
Bray George A.,
Cheskin Lawrence J.,
Curtis Jeffrey M.,
Egan Caitlin,
Evans Mary,
Foreyt John P.,
Ghazarian Siran,
Barone Gibbs Bethany,
Glasser Stephen P.,
W. Gregg Edward,
Hazuda Helen P.,
Hesson Louise,
Hill James O.,
Horton Edward S.,
Hubbard Van S.,
Jakicic John M.,
Jeffery Robert W.,
Johnson Karen C.,
Kahn Steven E.,
Kitabchi Abbas E.,
Kitzman Dalane,
Knowler William C.,
Lipkin Edward,
Michaels Sara,
Montez Maria G.,
Nathan David M.,
Nyenwe Ebenezer,
Patricio Jennifer,
Peters Anne,
PiSunyer Xavier,
Pownall Henry,
Reboussin David M.,
Ryan Donna H.,
Wadden Thomas A.,
Wagenknecht Lynne E.,
Wyatt Holly,
Wing Rena R.,
Yanovski Susan Z.
Publication year - 2020
Publication title -
obesity
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.438
H-Index - 199
eISSN - 1930-739X
pISSN - 1930-7381
DOI - 10.1002/oby.22676
Subject(s) - medicine , hazard ratio , overweight , myocardial infarction , type 2 diabetes , diabetes mellitus , confounding , stroke (engine) , angina , statin , proportional hazards model , physical therapy , disease , obesity , confidence interval , endocrinology , mechanical engineering , engineering
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.