Title: Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial

Hudson, JI et al.


What You Need to Know:

Results of a multinational phase 3 study found that for patients with moderate to severe binge-eating disorder, continued treatment with lisdexamfetamine dimesylate reduced the risk of relapse over 6 months compared to placebo.

Trial Design:

  • Randomized, double-blind, placebo-controlled, phase 3 study evaluated the efficacy of lisdexamfetamine dimesylate in adult patients with “moderate to severe binge-eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions−Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline)”
  • 12-week open-label phase: included a 4-week dose optimization period (50 or 70mg of lisdexamfetamine dimesylate) and an 8-week dose maintenance period; 418 patients enrolled
  • 26-week, double-blind, randomized withdrawal phase: included 275 “lisdexamfetamine responders” from the open-label phase (patients who had 4 consecutive weeks with ≥1 binge eating day/week and CGI-S scores ≥2 at week 12); patients were randomized to receive continued lisdexamfetamine (n=137) or placebo (n=138)
  • Primary endpoint: time to relapse (defined as 2 consecutive weeks of ≥2 binge-eating days/week and ≥2-point increase in the CGI-S score from withdrawal baseline)
  • Treatment-emergent adverse events were also assessed

Key Outcomes:

  • Proportion of lisdexamfetamine responders who met relapse criteria: 3.7% in the lisdexamfetamine group (5/136) versus 32.1% in the placebo group (42/131)
  • “Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37; P<.001) for time to relapse; the hazard ratio, based on a Cox proportional hazards model for lisdexamfetamine vs placebo, was 0.09 (95% CI, 0.04-0.23)”
  • Treatment-emergent adverse events: consistent with previously reported data