Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder

Abstract

IMPORTANCE Binge-eating disorder (BED), a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome, lacks approved pharmacotherapies.OBJECTIVE To examine the efficacy and safety of lisdexamfetamine dimesylate, a dextroamphetamine prodrug, to treat moderate to severe BED. DESIGN, SETTING, AND PARTICIPANTSWe performed a randomized, double-blind, parallel-group, forced dose titration, placebo-controlled clinical trial at 30 sites from May 10, 2011, through January 30, 2012. Safety and intention-to-treat analyses included 259 and 255 adults with BED, respectively.INTERVENTIONS Lisdexamfetamine dimesylate at dosages of 30, 50, or 70 mg/d or placebo were provided to study participants (1:1:1:1). Dosages were titrated across 3 weeks and maintained for 8 weeks. We followed up participants for a mean (SD) of 7 (2) days after the last dose. MAIN OUTCOMES AND MEASURESWe assessed the change in binge-eating (BE) behaviors measured as days per week (baseline to week 11) with a mixed-effects model using transformed log (BE days per week) + 1. Secondary measures included BE cessation for 4 weeks. Safety assessments included treatment-emergent adverse events, vital signs, and change in weight. RESULTS At week 11, log-transformed BE days per week decreased with the 50-mg/d (least squares [LS] mean [SE] change, −1.49 [0.066]; P = .008) and 70-mg/d (LS mean [SE] change, −1.57 [0.067]; P < .001) treatment groups but not the 30-mg/d treatment group (LS mean [SE]change, −1.24 [0.067]; P = .88) compared with the placebo group. Nontransformed mean (SD) days per week decreased for placebo and the 30-, 50-, and 70-mg/d treatment groups by −3.3 (2.04), −3.5 (1.95), −4.1 (1.52), and −4.1 (1.57), respectively. The percentage of participants achieving 4-week BE cessation was lower with the placebo group (21.3%) compared with the 50-mg/d (42.2% [P = .01]) and 70-mg/d (50.0% [P < .001]) treatment groups. The incidence of any treatment-emergent adverse events was 58.7% for the placebo group and 84.7% for the combined treatment group. In the treatment groups, 1.5% of participants had serious treatment-emergent adverse effects. Events with a frequency of at least 5% and changes in heart rate were generally consistent with the known safety profile. The mean (SD) change in body weight was −0.1 (3.09), −3.1 (3.64), −4.9 (4.43), −4.9 (3.93), and −4.3 (4.09) kg for the placebo group, the 30-, 50-, and 70-mg/d treatment groups, and the combined treatment groups, respectively (P < .001 for each dose vs placebo group comparison in post hoc analysis). CONCLUSIONS AND RELEVANCEThe 50-and 70-mg/d treatment groups demonstrated efficacy compared with the placebo group in decreased BE days, BE cessation, and global improvement. The safety profile was generally consistent with previous findings in adults with attentiondeficit/hyperactivity disorder. Further investigation of lisdexamfetamine in BED is ongoing. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01291173

Horizons in the Pharmacotherapy of Obesity

“…Lisdexamfetamine was already used for the treatment of attention deficit hyperactivity disorder. Weight loss in an 8-week study was 4.2 kg higher in subjects treated with lisdexamfetamine than in those treated with placebo [48]. Eleven-and twelve-week studies have recorded weight losses of between 5.2 and 6.25% [49].…”

Methylphenidate treatment for binge-eating disorder in a 12-year-old boy

“…Stimulants were also used for BED. In a study conducted by McElroy et al, the use of lisamfetamine has been shown to reduce the frequency of exacerbations in adults with binge-eating disorders [8]. There are case reports about methylphenidate use for bulimia nervosa (but not for BED) in adults [9][10][11][12], but to our knowledge, to date, no case has been reported methylphenidate use for BED in children and adolescents in the literature.…”

Normalizing the Neural Correlates of Binge-Eating Disorder with Lisdexamfetamine: A Case Report and Literature Review

“…Further analysis shows that the change in theta power is driven primarily by a decrease of power in the right inferior frontal gyrus after treatment (BA 47 or F8 electrode) as shown in with BED, also listed on the LDX prescription insert, include: dry mouth, headache, insomnia, decreased appetite, feeling jittery, anxiety, and increased heart rate and blood pressure [1] [7] [19].…”

“…It was initially specified for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), and later was proven to also have efficacy in limiting the occurrence of binge-eating behaviours [1] [4] [5] [6] [7].…”