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Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials.
Neuropsychopharmacology 2016; 41(5):1251-60N

Abstract

The efficacy and safety of lisdexamfetamine dimesylate (LDX) vs placebo in binge eating disorder (BED) was evaluated in two multicenter, double-blind, placebo-controlled trials. Adults (study 1, n=383; study 2, n=390) meeting DSM-IV-TR BED criteria were randomized (1:1) to placebo or LDX (50 or 70 mg/day) dose titration; optimized doses were maintained to the end of double-blind treatment (week 12/early termination). Change from baseline in binge eating days/week at weeks 11-12 (primary efficacy endpoint) was assessed with mixed-effects models for repeated measures. Secondary endpoints related to binge eating and medical parameters, safety, and treatment compliance were also assessed. Least squares mean (95% CI) treatment differences for change from baseline binge eating days/week at weeks 11-12 significantly favored LDX (study 1: -1.35 [-1.70, -1.01]; study 2: -1.66 [-2.04, -1.28]; both P<0.001). In both studies, treatment-emergent adverse events (TEAEs) reported by ⩾10% of LDX participants were dry mouth, insomnia, and headache. Serious TEAEs occurred in two (1.1%) placebo participants in each study and in three (1.6%) and one (0.6%) LDX participants in study 1 and study 2, respectively. Across studies, mean increases from baseline at week 12/early termination with LDX for pulse and systolic and diastolic blood pressure ranged from 4.41-6.31 b.p.m. and 0.2-1.45 and 1.06-1.83 mm Hg, respectively. LDX (50 and 70 mg/day) was superior to placebo in decreasing binge eating days/week from baseline and improving binge eating-related key secondary endpoints. Safety results appear consistent with the known safety profile of LDX.

Authors+Show Affiliations

Lindner Center of HOPE, Mason, OH, USA. Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.Biological Psychiatry Laboratory, McLean Hospital, Belmont, MA, USA. Department of Psychiatry, Harvard Medical School, Belmont, MA, USA.Global Clinical Development, Shire, Wayne, PA, USA.Clinical Development Operations & Biometrics, Shire, Wayne, PA, USA.Global Clinical Development, Shire, Wayne, PA, USA.Global Clinical Development, Shire, Wayne, PA, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26346638

Citation

McElroy, Susan L., et al. "Lisdexamfetamine Dimesylate for Adults With Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials." Neuropsychopharmacology : Official Publication of the American College of Neuropsychopharmacology, vol. 41, no. 5, 2016, pp. 1251-60.
McElroy SL, Hudson J, Ferreira-Cornwell MC, et al. Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials. Neuropsychopharmacology. 2016;41(5):1251-60.
McElroy, S. L., Hudson, J., Ferreira-Cornwell, M. C., Radewonuk, J., Whitaker, T., & Gasior, M. (2016). Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials. Neuropsychopharmacology : Official Publication of the American College of Neuropsychopharmacology, 41(5), pp. 1251-60. doi:10.1038/npp.2015.275.
McElroy SL, et al. Lisdexamfetamine Dimesylate for Adults With Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials. Neuropsychopharmacology. 2016;41(5):1251-60. PubMed PMID: 26346638.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials. AU - McElroy,Susan L, AU - Hudson,James, AU - Ferreira-Cornwell,M Celeste, AU - Radewonuk,Jana, AU - Whitaker,Timothy, AU - Gasior,Maria, Y1 - 2015/09/09/ PY - 2015/04/01/received PY - 2015/07/02/revised PY - 2015/07/07/accepted PY - 2015/9/9/entrez PY - 2015/9/9/pubmed PY - 2016/12/15/medline SP - 1251 EP - 60 JF - Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology JO - Neuropsychopharmacology VL - 41 IS - 5 N2 - The efficacy and safety of lisdexamfetamine dimesylate (LDX) vs placebo in binge eating disorder (BED) was evaluated in two multicenter, double-blind, placebo-controlled trials. Adults (study 1, n=383; study 2, n=390) meeting DSM-IV-TR BED criteria were randomized (1:1) to placebo or LDX (50 or 70 mg/day) dose titration; optimized doses were maintained to the end of double-blind treatment (week 12/early termination). Change from baseline in binge eating days/week at weeks 11-12 (primary efficacy endpoint) was assessed with mixed-effects models for repeated measures. Secondary endpoints related to binge eating and medical parameters, safety, and treatment compliance were also assessed. Least squares mean (95% CI) treatment differences for change from baseline binge eating days/week at weeks 11-12 significantly favored LDX (study 1: -1.35 [-1.70, -1.01]; study 2: -1.66 [-2.04, -1.28]; both P<0.001). In both studies, treatment-emergent adverse events (TEAEs) reported by ⩾10% of LDX participants were dry mouth, insomnia, and headache. Serious TEAEs occurred in two (1.1%) placebo participants in each study and in three (1.6%) and one (0.6%) LDX participants in study 1 and study 2, respectively. Across studies, mean increases from baseline at week 12/early termination with LDX for pulse and systolic and diastolic blood pressure ranged from 4.41-6.31 b.p.m. and 0.2-1.45 and 1.06-1.83 mm Hg, respectively. LDX (50 and 70 mg/day) was superior to placebo in decreasing binge eating days/week from baseline and improving binge eating-related key secondary endpoints. Safety results appear consistent with the known safety profile of LDX. SN - 1740-634X UR - https://www.unboundmedicine.com/medline/citation/26346638/Lisdexamfetamine_Dimesylate_for_Adults_with_Moderate_to_Severe_Binge_Eating_Disorder:_Results_of_Two_Pivotal_Phase_3_Randomized_Controlled_Trials_ L2 - http://dx.doi.org/10.1038/npp.2015.275 DB - PRIME DP - Unbound Medicine ER -