These findings, published today in JAMA Psychiatry, provide the first evidence of lisdexamfetamine’s effectiveness as a maintenance therapy for BED.
The safety and tolerability profiles of lisdexamfetamine were favorable as well, noted lead author James Hudson, M.D., Sc.D., of Harvard Medical School and colleagues. “Overall, there was no evidence of new trends in the safety profile of lisdexamfetamine following long-term treatment or abrupt discontinuation,” they wrote.
For this study, 418 adults with moderate to severe BED (defined as at least three binge eating days per week and Clinical Global Impression-Severity [CGI-S] scores of 4 or higher) were recruited at 49 sites across the globe. All the participants initially received 12 weeks of lisdexamfetamine therapy (50 mg or 70 mg once daily); the 275 responders were then randomized to continue lisdexamfetamine therapy or placebo for 26 weeks.
Lisdexamfetamine also outperformed placebo on secondary measures, including total binge eating days per week, CGI-S scores, and obsessive-compulsive symptom scores.
“Although the clinical significance of the findings is unclear, a large proportion of participants in the placebo group failed to relapse,” the authors wrote. “This is an important issue because it could have implications for how recommendations about the need for long-term lisdexamfetamine use in individuals with BED who respond to lisdexamfetamine acutely are made.”
This study was supported by Shire Development LLC, manufacturer of lisdexamfetamine (Vyvanase).
To read more about this topic, see the Psychiatric News articles “FDA Approves First Drug for Binge-Eating Disorder” and “New DSM Guide Describes Changes to Eating, Elimination, Sleep Disorders Criteria.”
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