Efficacy, Safety and Tolerability of Lisdexamfetamine Dimesylate Treatment Compared With Placebo in Adults With Binge-Eating Disorder: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

INTRODUCTION

Binge-Eating Disorder (BED) causes significant psychosocial impairment and comorbidities like obesity, depression, and anxiety. Given the limited effectiveness of current treatments, Lisdexamfetamine dimesylate (LDX), approved for Attention-Deficit/Hyperactivity Disorder- ADHD and BED in the U.S., may provide a promising alternative by enhancing impulse control and targeting reward pathways.

OBJECTIVE

This study aims to assess the efficacy, safety, and tolerability of LDX compared with placebo in adults with BED.

METHODS

We systematically searched PubMed, Embase and Cochrane databates for randomised controlled trials (RCTs). We used a random-effects model with a 95% confidence interval (CI) to pool the data. Outcomes analysed included binge-eating frequency, Yale-Brown Obsessive-Compulsive Scale for Binge-Eating (Y-BOCS-BE), weight change, treatment-emergent adverse events (TEAEs), and discontinuation rates. Sensitivity analyses were performed to assess heterogeneity. This systematic review and meta-analysis was prospectively registered in PROSPERO (CRD42024619617).

RESULTS

Five RCTs were included in this meta-analysis, encompassing a total of 988 participants. LDX significantly reduced binge-eating days per week by an average of 1.29 days and decreased obsessive-compulsive behaviours by 6.16 points on the Y-BOCS-BE scale, compared with placebo. Additionally, LDX led to a significant weight reduction with an average decrease of 1.31 standardised mean differences (SMD). Diarrhoea was identified as a significant side effect not previously acknowledged in guidelines (RR = 4.06). Discontinuation rates were comparable between LDX and placebo.

CONCLUSION

LDX demonstrates significant efficacy in reducing binge-eating behaviours and associated obsessive-compulsive symptoms in patients with BED, with a tolerable safety profile. These findings support the clinical use of LDX for managing BED.