Robert T. Rubin, MD, PhD.Dr. Rubin has disclosed that he has no relevant financial or other interests in any commercial companies pertaining to this educational activity.
Review of: Hudson JI et al, JAMA Psychiatry 2017;74(9):903–910.
Lisdexamfetamine (Vyvanse) is an extended release amphetamine-based stimulant that is approved for both ADHD and binge eating disorder (BED). To refresh your memory, BED is defined as recurrent episodes (at least once a week over 3 months) of binge eating without compensatory weight loss behaviors, such as purging or excessive exercise. Vyvanse was approved for BED in 2015, and it’s currently the only medication approved for this indication. The approval was based on the results of two 12-week randomized controlled trials, in which the stimulant (at doses of 50–70 mg/day) was more effective than placebo at reducing binge frequency. (See TCPR June 2015 for more details.)
This study, funded by Shire, Vyvanse’s manufacturer, was designed to test Vyvanse’s efficacy over the long term for patients with more severe BED. The study included 411 patients from 49 centers in North America and Europe who were binging at least 3 times per week. They were initially treated for 12 weeks with Vyvanse (50–70 mg per day) in an open-label study, and 270 of these patients responded, as defined by no more than 1 binge per week for 4 consecutive weeks. The responders then were randomized, in double-blind fashion, to continued Vyvanse at the same dose, or to placebo for another 6 months.
Patients assigned to continue Vyvanse did markedly better—only 3.7% of these patients relapsed vs 32% of the patients switched to placebo. Among the 32% of placebo-treated patients, half of them relapsed within the first month. Side effects in both groups were mild; there were modest increases in blood pressure and pulse in the Vyvanse group, as well as some weight loss.
TCPR’s Take This study shows that Vyvanse is effective for BED over the long term, but patients who are reluctant to take a stimulant for BED can be reassured that once they get better, they most likely can taper off the Vyvanse without relapsing. It would be nice if we could predict which patients can successfully be weaned from Vyvanse, but this study didn’t examine that issue. Based on this study, you can tell your BED patients that—if they come off the stimulant—they have about a 66% chance of maintaining their response.