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Heterogeneity of Treatment Effects From an Intensive Lifestyle Weight Loss Intervention on Cardiovascular Events in Patients With Type 2 Diabetes: Data From the Look AHEAD Trial.

Authors
  • de Vries, Tamar I1
  • Dorresteijn, Jannick A N1
  • van der Graaf, Yolanda2
  • Visseren, Frank L J1
  • Westerink, Jan3
  • 1 Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands. , (Netherlands)
  • 2 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. , (Netherlands)
  • 3 Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands [email protected] , (Netherlands)
Type
Published Article
Journal
Diabetes care
Publication Date
Oct 01, 2019
Volume
42
Issue
10
Pages
1988–1994
Identifiers
DOI: 10.2337/dc19-0776
PMID: 31416897
Source
Medline
Language
English
License
Unknown

Abstract

To explore the presence of heterogeneity of treatment effect (HTE) of an intensive lifestyle intervention on the occurrence of major cardiovascular events (MACE) in overweight or obese patients with type 2 diabetes, and to identify patient characteristics associated with individual treatment effect. In 4,901 participants from the Action for Health in Diabetes (Look AHEAD) trial, a penalized Cox regression model to predict treatment effect of intensive lifestyle intervention for the risk of MACE was derived, including all possible treatment-by-covariate interaction terms. The ability of the model to predict HTE was confirmed by calculating hazard ratios (HRs) and absolute risk change in quartiles of predicted treatment effect, and baseline patient characteristics were compared between quartiles. In quartile 1 of predicted treatment effect, with the highest predicted risk reduction, there was a significant treatment benefit of intensive lifestyle intervention (HR 0.64 [95% CI 0.49-0.83]), whereas there was no effect from treatment in quartiles 2 and 3 (HR 0.81 [95% CI 0.58-1.14] and 1.13 [95% CI 0.80-1.60], respectively) and a detrimental effect in quartile 4 (HR 1.37 [95% CI 1.09-1.73]). Several patient characteristics in demographics, medical history, physical examination, and laboratory values were associated with the level of treatment effect. This post hoc analysis of the Look AHEAD trial showed that an intensive lifestyle intervention aimed at weight loss may reduce cardiovascular events in selected patients but may have a detrimental treatment effect in others. © 2019 by the American Diabetes Association.

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