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Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial.
JAMA Psychiatry 2015; 72(3):235-46JP

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 PARTICIPANTS

We 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 MEASURES

We 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 RELEVANCE

The 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 attention-deficit/hyperactivity disorder. Further investigation of lisdexamfetamine in BED is ongoing.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01291173.

Authors+Show Affiliations

Research Institute, Lindner Center of HOPE, Mason, Ohio2Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.Department of Psychiatry, McLean Hospital/Harvard Medical School, Belmont, Massachusetts.Neuropsychiatric Research Institute, Fargo, North Dakota5Department of Neuroscience, University of North Dakota School of Medicine, Fargo.Department of Psychology, Washington University School of Medicine, St Louis, Missouri.Shire, Wayne, Pennsylvania.Shire, Wayne, Pennsylvania.Shire, Wayne, Pennsylvania8currently with CSL Behring, King of Prussia, Pennsylvania.Shire, Wayne, Pennsylvania.Shire, Wayne, Pennsylvania9currently with Sage Therapeutics, Cambridge, Massachusetts.Shire, Wayne, Pennsylvania.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25587645

Citation

McElroy, Susan L., et al. "Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-eating Disorder: a Randomized Clinical Trial." JAMA Psychiatry, vol. 72, no. 3, 2015, pp. 235-46.
McElroy SL, Hudson JI, Mitchell JE, et al. Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry. 2015;72(3):235-46.
McElroy, S. L., Hudson, J. I., Mitchell, J. E., Wilfley, D., Ferreira-Cornwell, M. C., Gao, J., ... Gasior, M. (2015). Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry, 72(3), pp. 235-46. doi:10.1001/jamapsychiatry.2014.2162.
McElroy SL, et al. Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-eating Disorder: a Randomized Clinical Trial. JAMA Psychiatry. 2015;72(3):235-46. PubMed PMID: 25587645.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. AU - McElroy,Susan L, AU - Hudson,James I, AU - Mitchell,James E, AU - Wilfley,Denise, AU - Ferreira-Cornwell,M Celeste, AU - Gao,Joseph, AU - Wang,Jiannong, AU - Whitaker,Timothy, AU - Jonas,Jeffrey, AU - Gasior,Maria, PY - 2015/1/15/entrez PY - 2015/1/15/pubmed PY - 2015/6/9/medline SP - 235 EP - 46 JF - JAMA psychiatry JO - JAMA Psychiatry VL - 72 IS - 3 N2 - 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 PARTICIPANTS: We 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 MEASURES: We 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 RELEVANCE: The 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 attention-deficit/hyperactivity disorder. Further investigation of lisdexamfetamine in BED is ongoing. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01291173. SN - 2168-6238 UR - https://www.unboundmedicine.com/medline/citation/25587645/full_citation L2 - https://jamanetwork.com/journals/jamapsychiatry/fullarticle/10.1001/jamapsychiatry.2014.2162 DB - PRIME DP - Unbound Medicine ER -