Lisdexamfetamine was shown to reduce the risk of relapse in participants with moderate to severe binge-eating disorder over a 26-week period, according to a study published in JAMA Psychiatry.
In this multinational phase 3 study, the safety and efficacy of lisdexamfetamine was evaluated in adults with moderate to severe binge-eating disorder, defined as >3 binge-eating days per week for 14 days prior to baseline and Clinical Global Impressions-Severity scores >4. Researchers randomly assigned lisdexamfetamine responders to placebo or continued lisdexamfetamine 50 mg or 70 mg following a 12-week open-label phase (dose optimization, 4 weeks; dose maintenance, 8 weeks).
A total of 418 participants were enrolled in the open-label phase; 411 were included in the safety analysis, and 275 lisdexamfetamine responders were randomly assigned to receive either placebo (mean age 40.1; 85.5% women; mean body mass index [BMI] 34.8) or continued lisdexamfetamine (mean age 37.3; 89.7% women; mean BMI 33.06).
Fewer participants receiving lisdexamfetamine in the randomized-withdrawal phase met relapse criteria (n=5/136, 3.7%) compared with participants receiving placebo (n=42/131, 32.1%; hazard ratio [HR], 0.09 [95% CI, 0.04-0.23]). Furthermore, lisdexamfetamine was superior to placebo for time to relapse, measured with the log-rank test (χ12, 40.37; P <.001).
Treatment-emergent adverse events were more common in the lisdexamfetamine group. Most adverse events were mild or moderate and consistent with the known side effect profile of lisdexamfetamine, according to the researchers.
The study investigators concluded that “the relapse risk with lisdexamfetamine was markedly lower than placebo, with the estimated hazard for relapse during lisdexamfetamine therapy being 11 times lower than with placebo.”
Hudson JI, McElroy SL, Ferreira-Cornwell C, Radewonuk J, Gasior M. Efficacy of lisdexamfetamine in adults with moderate to severe binge-eating disorder: A randomized clinical trial [published online July 12, 2017]. JAMA Psychiatry. doi:10.1001/jamapsychiatry.2017.1889