Quality of life, binge eating and sexual function in participants treated for obesity with sustained release naltrexone/bupropion

Abstract

Objective: This multicenter, randomized, controlled, open-label trial examined weight-related quality of life, control over eating behaviour and sexual function after 26 weeks of treatment with either 32 mg naltrexone sustained release (SR)/360 mg bupropion SR plus a comprehensive lifestyle intervention program (NB + CLI, N = 153) or usual care (UC, N = 89), which included minimal lifestyle intervention.

Methods: Impact of Weight on Quality of Life-Lite, Binge Eating Scale and Arizona Sexual Experiences Scale were assessed at baseline (BL) and weeks 16 and 26.

Results: NB + CLI and UC participants lost 9.46 and 0.94% respectively of initial body weight at week 26 (P < 0.0001). NB + CLI participants had greater improvements in Impact of Weight on Quality of Life-Lite total score than UC participants (P < 0.0001). In participants with moderate/severe Binge Eating Scale scores at BL, 91% of NB + CLI and 18% of UC participants experienced categorical improvements. In participants with Arizona Sexual Experiences Scale-defined sexual dysfunction at BL, 58% of NB + CLI and 19% of UC participants no longer met dysfunction criteria at week 26. The most frequent adverse events leading to discontinuation before week 26 in NB + CLI included nausea (10.5%); anxiety (3.3%); and headache, hypertension, insomnia and palpitations (1.3% each).

Conclusion: Compared with UC, participants treated with NB + CLI experienced greater improvements in weight-related quality of life, control over eating behaviour, and sexual function.

Keywords: Binge Eating Scale; Contrave®; IWQOL‐Lite; Mysimba®.

Figure 1

Participants and group assignments. A total of 242 intent‐to‐treat participants were randomly assigned 1.75:1 to NB + CLI and UC groups. AE, adverse event; LTFU, lost to follow‐up; Other, protocol deviation or withdrawal of consent; N/A, not applicable; CLI, comprehensive lifestyle intervention; NB, sustained release combination of naltrexone and bupropion; Wk 16, evaluation to continue treatment at week 16 visit.

Figure 2

Change in Impact of Weight on Quality of Life‐Lite (IWQOL‐Lite). (a) Change in total score from baseline at weeks 16 and 26. (b) Change in IWQOL‐Lite subscale scores from baseline to week 26. Change in score was greater in NB + CLI than UC for all subscales. (c) Change in total score from baseline to week 26 by weight loss category. Change in IWQOL‐Lite total score was significantly greater in NB + CLI than UC for weight loss categories of 0 to 5% (P = 0.0004) and 10 to <15% (P = 0.0384). For all panels, points represent least square means and error bars are standard error, *P < 0.05, ***P < 0.001 (NB + CLI vs. UC).

Figure 3

Binge Eating Scale. (a) Change in total BES from baseline. (b) Total score over time for NB participants with and without significant binge eating problem at baseline (dashed lines provide reference to cut‐off thresholds for binge eating). Total score ≤17 indicates no significant binge eating problem, scores from 18 to 26 indicate moderate binge eating and scores ≥27 indicate severe binge eating. (c) Participants with moderate or severe binge eating at baseline (i.e. BES score >17). Proportion of participants with improvement in Binge Eating Scale categorization from baseline to week 26. A greater proportion of NB + CLI (91.3%) than UC (17.6%) participants improved in BES categorization from baseline to week 26 (P < 0.001). For all panels, points represent least square means and error bars are standard error, ***P < 0.001 when UC is compared with NB + CLI for the same time point.

Figure 4

Arizona Sexual Experiences Scale. (a) Change in total ASEX from baseline. Results are displayed for the entire PP population (groups ‘NB + CLI PP’ and ‘UC PP’) as well as those participants who were classified as having sexual dysfunction at baseline (groups ‘NB + CLI dysfunction’ and ‘UC dysfunction’). (b) Proportion of participants with improvement in ASEX categorization from baseline to week 26 in the population of participants with baseline scores indicative of dysfunction. A greater proportion of NB + CLI (58.3%) than UC (19.4%) participants improved in ASEX categorization from baseline to week 26 (P < 0.002). 2 participants did not have data at week 26 so were excluded. For all panels, points represent least square means and error bars are standard error, *P < 0.05 when UC PP is compared with NB PP for the same timepoint, ***P < 0.001 when UC dysfunction is compared with NB + CLI dysfunction for the same time point.