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

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.

The relationship between early weight loss and weight loss at 1 year with naltrexone ER/bupropion ER combination therapy.

BACKGROUND/OBJECTIVES: Weight management medications increase the likelihood that patients will achieve clinically meaningful improvements in cardiovascular, metabolic and other weight-related measures of health. However, the weight loss achieved with any weight management intervention can vary widely among individuals, and patients who do not respond to pharmacotherapy by achieving clinically meaningful weight loss should discontinue therapy. We characterized 1-year weight loss in the phase 3 clinical trial program of the weight management medication, naltrexone/bupropion 32/360 mg (NB), as well as the relationship between early weight loss and long-term weight loss, particularly with respect to participants who achieved the clinically recommended threshold of ⩾5% weight loss by Week 16. PARTICIPANTS/METHODS: Data from participants from each of the four phase 3, randomized, placebo-controlled, 56-week clinical trials with NB were pooled (modified intent-to-treat population; NB N=2043, Placebo N=1319). This exploratory analysis examined the relationship between participant achievement of various weight loss thresholds early in treatment (at Week 8, 12 or 16) and the associated weight loss at Week 56 (Completers population; NB N=1310, Placebo N=763). RESULTS: In the NB participants who completed 1 year of treatment, weight loss of at least 5% at Week 16 (n=873) was associated with least-squares mean weight loss of 11.7% at Week 56 and 85% of these participants had Week 56 weight loss of ⩾5%. Eighty percent (95% confidence interval: 78-82%) of the participants who would, and would not, achieve ⩾5% weight loss at Week 56 were correctly identified using the clinically recommended threshold of ⩾5% at Week 16. Safety and tolerability of NB was similar to previously published reports. CONCLUSIONS: Participants who meet the Week 16 threshold of ⩾5% weight loss are likely to maintain clinically significant weight loss after 1 year of treatment. Further evaluations are required to evaluate improvements in measures of cardiovascular and metabolic risk.

Patient-reported quality of life in a randomized placebo-controlled trial of naltrexone/bupropion for obesity.

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 Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, in a pooled analysis of patient-level data from four randomized controlled Phase 3 studies of naltrexone/bupropion (NB32 or Contrave®). The total number of subjects was 3362 (NB32 = 2043; placebo = 1319; mean body mass index = 36.3 kg m(2); mean age = 46). Improvements in IWQOL-Lite Total Score were greater in subjects treated with NB32 (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 NB32 vs. placebo on all five subscale scores of the IWQOL-Lite. Fifty per cent of NB32-treated subjects achieved clinically meaningful improvements in IWQOL-Lite Total Score 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-Lite Total Score (19.3 points [SE 0.7] for NB32 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 NB32 than placebo.