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History of cardiovascular disease, intensive lifestyle intervention, and cardiovascular outcomes in the Look AHEAD Trial
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2 2020
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Source: Obesity (Silver Spring). 28(2):247-258
Details:
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Alternative Title:Obesity (Silver Spring)
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Description:OBJECTIVE-
To examine intensive lifestyle intervention (ILI) effects on cardiovascular disease (CVD), Look AHEAD randomized 5145 participants with Type 2 diabetes and overweight/obesity to ILI or Diabetes Support and Education (DSE). While the primary outcome did not differ, there was suggestive evidence of heterogeneity for pre-specified baseline CVD history subgroups (interaction p=0.063). Event rates were higher in ILI among those with CVD history (hazard ratio [HR] 1.13 [95% CI 0.90-1.41]) and lower without CVD (HR, 0.86 [95% CI 0.72-1.02]).
METHODS-
Post-hoc analyses of rates of primary composite outcome and components: adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina; and three secondary composite 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 non-fatal 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 CVD history, statin use was high and similar by group. In those without, LDL-C levels were higher (p=0.003) and statin use lower (p=<0.001) in ILI.
CONCLUSIONS:
Intervention response heterogeneity was significant for non-fatal MI. Response heterogeneity may need consideration in CVD outcome trial design.
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Pubmed ID:31898874
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Pubmed Central ID:PMC6980987
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Volume:28
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Issue:2
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