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Lisdexamfetamine bimesylate comparable to placebo for binge eating disorder
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Compared with placebo, participants with binge eating disorder demonstrated comparable clinical characteristics and responses to dose-optimized lisdexamfetamine bimesylate across age and gender subgroups, according to findings published in Journal of Clinical Psychiatry.
In previous placebo-controlled trials, lisdexamfetamine bimesylate (LDX) resulted in statistically superior decreases in binge eating days per week compared with placebo in adults with binge eating disorder (BED), Susan G. Kornstein, MD, department of psychiatry and Institute for Women’s Health, Virginia Commonwealth University, and colleagues wrote.
“Although previous studies have not examined the effects of gender or age on treatment response to pharmacotherapy for BED, it has been reported that younger age and female gender are moderators of treatment response to pharmacotherapy in adults diagnosed with BED,” they wrote. “Examination of clinical characteristics and treatment responses as a function of gender and age may further our understanding of BED and identify factors impacting the clinical outcomes of pharmacotherapy.”
In their post-hoc analyses, researchers reported the clinical characteristics and LDX treatment effects, based on gender and age in adults with moderate to severe binge eating disorder randomized to receive 12 weeks of dose-optimized LDX (50 mg or 70 mg) or placebo in two studies.
Results from the pooled safety analysis and full analysis sets included 745 participants from the first study (640 women; 398 aged younger than 40 years) and 724 participants from the second (627 women; 386 aged younger than 40 years).
Analyses revealed a comparable number of binge eating days per week at baseline across gender (4.6 to 4.7 days) and age (4.6 to 4.9 days), as well as a comparable Yale-Brown Obsessive-Compulsive Scale modified for Binge Eating (Y-BOCS-BE) total score by gender (20.42 to 21.7) and age (21.4 to 21.63).
The results showed that dose-optimized LDX resulted in nominally superior reductions in binge eating days per week and Y-BOCS-BE total scores at week 12 compared with placebo and was linked to nominally greater percentages of participants showing improvement on the Clinical Global Impressions–Improvement scale in both gender and age subgroups (all P < .001). Furthermore, there was no evidence of statistically significant interactions by gender or age subgroup, according to Kornstein and colleagues.
Across all subgroups, the researchers found that LDX was tied to more treatment-emergent adverse events than placebo and with increases in blood pressure and pulse.
“This article focused on the influence of gender and age, but the influence of other factors, including the duration of BED diagnosis or of race or ethnicity on BED characteristics and treatment response, are also of interest,” they wrote. “Therefore, it is important to further examine these factors in future studies.” – by Savannah Demko
Disclosures: Kornstein reports support from Allergan, Marinus, Palatin, Pfizer and Takeda as well as royalties from Guilford Press. She also reports consulting for Alkermes, Allergan, Lilly, Palatin, Pfizer, Shire, Sunovion and Takeda. Please see the study for all other authors’ relevant financial disclosures.