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Patient‐reported quality of life in a randomized placebo‐controlled trial of naltrexone/bupropion for obesity
Author(s) -
Kolotkin R. L.,
Chen S.,
Klassen P.,
Gilder K.,
Greenway F. L.
Publication year - 2015
Publication title -
clinical obesity
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 12
eISSN - 1758-8111
pISSN - 1758-8103
DOI - 10.1111/cob.12108
Subject(s) - medicine , bupropion , naltrexone , placebo , randomized controlled trial , obesity , quality of life (healthcare) , physical therapy , alternative medicine , smoking cessation , opioid , receptor , nursing , pathology
Summary Weight loss is associated with improved quality of life in some, but not all, weight loss trials. We evaluated changes at 56 weeks in quality of life, measured by the I mpact of W eight on Q uality of L ife‐ L ite ( IWQOL ‐ L ite) questionnaire, in a pooled analysis of patient‐level data from four randomized controlled Phase 3 studies of naltrexone/bupropion ( NB 32 or C ontrave®). The total number of subjects was 3362 ( NB 32 = 2043; placebo = 1319; mean body mass index = 36.3 kg m 2 ; mean age = 46). Improvements in IWQOL ‐ L ite Total Score were greater in subjects treated with NB 32 (11.9 points [ SE 0.3]) vs. placebo (8.2 points [ SE 0.3]; P < 0.001), corresponding to weight reductions of 7.0% ( SE 0.2) and 2.3% ( SE 0.2), respectively. Greater improvements were also observed for NB 32 vs. placebo on all five subscale scores of the IWQOL ‐ L ite. Fifty per cent of NB 32‐treated subjects achieved clinically meaningful improvements in IWQOL ‐ L ite T otal S core vs. 32.3% of placebo‐treated subjects (odds ratio, 95% confidence interval; 2.09, 1.79–2.44). Subjects losing the most weight (≥15% of baseline weight) experienced the greatest improvement in IWQOL ‐ L ite Total Score (19.3 points [ SE 0.7] for NB 32 and 18.7 points [ SE 1.3] for placebo; P = 0.624). Improved quality of life was associated with weight reduction and was achieved in more subjects treated with NB 32 than placebo.