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J Clin Psychiatry. 2019 Feb 26;80(2). pii: 18m12378. doi: 10.4088/JCP.18m12378.

Clinical Characteristics and Treatment Response to Lisdexamfetamine Dimesylate Versus Placebo in Adults With Binge Eating Disorder: Analysis by Gender and Age.

Author information

1
Department of Psychiatry and Institute for Women's Health, Virginia Commonwealth University, PO Box 980710, Richmond, VA 23298-0710. susan.kornstein@vcuhealth.org.
2
Department of Psychiatry and Institute for Women's Health, Virginia Commonwealth University, Richmond, Virginia, USA.
3
Biostatistics, Shire, Lexington, Massachussetts, a member of the Takeda group of companies.
4
Global Medical Affairs, Shire, Lexington, Massachussetts, a member of the Takeda group of companies.

Abstract

OBJECTIVE:

To describe clinical characteristics and lisdexamfetamine dimesylate (LDX) treatment effects, based on gender and age, in adults diagnosed with moderate to severe binge eating disorder (BED).

METHODS:

Adults diagnosed with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision-defined BED of moderate to severe severity were randomized to 12 weeks of dose-optimized LDX (50 or 70 mg) or placebo in 2 studies (conducted from November 26, 2012, to September 25, 2013 [study 1] and from November 26, 2012, to September 20, 2013 [study 2]). These post hoc analyses pooled data by gender (men vs women) and age (< 40 vs ≥ 40 years) across studies; reported P values are nominal (descriptive and unadjusted).

RESULTS:

The pooled safety analysis and full analysis sets included 745 and 724 participants, respectively (men, n = 105 and n = 97; women, n = 640 and n = 627; < 40 years, n = 398 and n = 386; ≥ 40 years, n = 347 and n = 338). Across subgroups, most participants had a body mass index ≥ 30 kg/m² (63.0%-75.5%). The mean baseline number of binge eating days/wk was comparable across gender (4.6-4.7) and age (4.6-4.9), as was Yale-Brown Obsessive Compulsive Scale modified for Binge Eating (Y-BOCS-BE) total score (gender, 20.42-21.70; age, 21.40-21.63). Least squares mean (95% CI) treatment differences nominally favored LDX in all subgroups (all P < .001) for changes from baseline in binge eating days/wk at weeks 11-12 and in Y-BOCS-BE total score at week 12; no interactions by gender or age were reported. Consistent with the overall profile of LDX, across all subgroups LDX was associated with higher frequencies of treatment-emergent adverse events than placebo and with increases in blood pressure and pulse.

CONCLUSIONS:

Across gender and age, participants exhibited comparable clinical characteristics and responses to dose-optimized LDX compared with placebo.

TRIAL REGISTRATION:

ClinicalTrials.gov identifiers: NCT01718483 and NCT01718509.

PMID:
30817099
DOI:
10.4088/JCP.18m12378
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