Yesterday's session in 57th ADA convention.
Sustained-release naltrexone/bupropion (NB) is approved in the United States for chronic weight
management as an adjunct to diet and physical activity. Phase 3 studies demonstrated significantly greater weight loss with NB vs. placebo in the setting of both standard and intensive lifestyle modification counseling. The current study examined the effects of NB (32mg/360mg) combined with a commercially-available telephone/web-based lifestyle intervention program, compared with usual care (UC; periodic diet and exercise advice), in overweight/obese subjects. Consistent with prescribing information, this study prospectively required NB subjects to exhibit =5% weight loss at Week 16, with no sustained increase in blood pressure, to continue treatment. Analyses were performed on subjects who remained on treatment through Week 26 (per protocol [PP] population), and on subjects with =1 post-baseline visit (modified intent-to-treat [mITT] population) using mixed-model repeated measures. The primary endpoint was change in weight at Week 26 in PP subjects. The randomized population (NB N=153, UC N=89) was 84% female, 78% white, with mean (SD) baseline age of 47 y (9.8) and BMI of 36.3 (4.3) kg/m2. The mITT population consisted of NB n=152 and UC n=88, and the PP population consisted of NB n=71 and UC n=82. The primary reasons for NB discontinuation were adverse events (n=35) and not meeting the Week 16 criteria (n=32). At 26 weeks, PP NB subjects exhibited 8.5% greater least squares mean [SE] weight change compared with UC subjects (-9.5[0.5]% vs. -0.9[0.5]%; p<0.001). Weight change in mITT subjects, which included subjects discontinued from treatment, was NB: -6.2% (0.5) vs. UC: -1.1% (0.6) (p<0.001). More patients with NB vs. UC achieved 5%, 10%, and 15% weight loss. AE profile was similar to Phase 3 trials. NB, when combined with lifestyle modification and used as recommended in clinical practice (i.e., =5% loss at week 16), resulted in nearly a 10% mean weight loss at 26 weeks.
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The mission of the American Diabetes Association is to prevent and cure diabetes and to improve the lives of all people affected by diabetes.
Sustained-release naltrexone/bupropion (NB) is approved in the U.S. for chronic weight management as an adjunct to diet and physical activity. This analysis examined patient-reported outcomes (PROs) after 26 weeks of open-label treatment in subjects randomly assigned to NB plus a commercially-available telephone/web-based lifestyle intervention program (N=153), or usual care (UC; periodic diet/exercise advice; N=89). Consistent with prescribing information, this study prospectively required NB subjects to exhibit =5% weight loss at Week 16, with no sustained increase in blood pressure, to continue treatment. Impact of Weight on Quality of Life-Lite (IWQoL-Lite), the Binge Eating Scale (BES), and the Arizona Sexual Function Scale (ASEX) were assessed at baseline (BL) and Weeks 16 and 26. Analyses were performed on subjects who remained on treatment through Week 26 (per protocol [PP] population): NB n=71, UC n=82, 84% female, 80% white, 48 years, and 36 kg/m2. At Week 26, NB elicited greater weight change (-9.5% vs. -0.9%, p<0.001) and improvement in all 3 PROs vs. UC. IWQoL-Lite total score (BL: 67 NB, 64 UC) improved with NB (+16.4 [1.5]; least squares mean change [SE]) vs. UC (-1.0 [1.4]; p<0.001); significant improvement was also seen in all 5 subdomains. At BL, 34% of NB subjects and 44% of UC subjects met the ASEX criteria for sexual dysfunction; at Week 26, over half (58%) of these NB subjects no longer met such criteria, compared to 19% of UC subjects. BES total score (BL 15 NB; 16 UC) was also significantly improved with NB (-6.8 [0.7]) vs. UC (+1.1 [0.7]; p<0.001). In subjects with moderate/severe BES scores at BL (32% of NB, 41% of UC subjects), categorical improvement was observed in 91% of these NB subjects vs. 18% in UC. Treatment with NB in a manner consistent with clinical practice was associated with improved weight-related quality of life, control of eating, and sexual function. Larger studies to confirm these outcomes are warranted.
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