Adult patients with binge eating disorder who were treated for 12 weeks with lisdexamfetamine dimesylate reported having 4 fewer binge days per week, and also experienced improvements in weight and triglyceride levels.
Clinicians have noticed for several years that some drugs for treating attention deficit hyperactivity disorder also appear to be effective in the off-label treatment of adult binge eating disorder. Now, data from a two-arm study presented at the American Psychiatric Association’s 167th annual meeting in New York City on May 6, 2014, appeared to confirm those informal observations for one medication, lisdexamfetamine dimesylate (brand name: Vyvanse), which was approved by the FDA in 2007 for the treatment ADHD.
“People with binge eating disorder often have impulsivity,” explained lead author Susan L. McElroy, MD, who is a professor of psychiatry at the University of Cincinnati College of Medicine, and the chief research officer of the Lindner Center of Hope, a mental health clinic in Mason, OH.
“Since this drug has shown to be effective in improving patients’ impulsivity for ADHD, it might be effective for binge eating, too,” she added.
The study consisted of two identical randomized, placebo-controlled, double-blind, phase III trials, conducted in a total of 93 sites in the US and Europe. Nearly 800 patients were enrolled, ranging in age from 18 to 55. Demographically, they were mainly Caucasian overweight women.
All patients had moderate to severe binge-eating disorder, which was defined during the screening process as experiencing at least one episode of binge eating per day for at least three days per week, for a period of two weeks.
During the 12-week trial, the participants began at a once-daily dose of lisdexamfetamine dimesylate 30 mg, titrating after one week up to 50 mg and then, if tolerated, to 70 mg. Patients could be reduced down to 50 mg at the third week if the higher dosage was not tolerated.
The results were dramatic. Patients who received the study drug reported nearly 4 fewer binge days per week, while the control group reported a decline of only 2.26 to 2.51 days.
The trial did not compare the effectiveness of lisdexamfetamine dimesylate at 50 mg versus 70 mg, McElroy said, but she and her colleagues found that the mean effective dose was 56.9 mg in the first study and 57.6 mg in the other. A previous phase II trial had shown that a 30 mg formulation was not effective.
In addition, participants treated with lisdexamfetamine dimesylate exhibited significant improvements in weight and triglyceride levels compared with the control group. One of the cohorts receiving the medication lost an average of 6.25% of their body weight and the other medicated cohort lost 5.57%, while one of the groups on placebo lost only a minimal percentage (0.15%) and the other group reported a minimal weight gain (0.1%).
Obesity, high cholesterol, high blood pressure, heart disease, and diabetes are among the most serious potential complications from binge eating. The disorder itself is considered the most common eating problem among American adults, affecting 2.8% of adults, or almost twice the percentage for the related conditions of anorexia and bulimia combined.
McElroy said the next step is to monitor the participants to see if they maintain their progress, although she had no details on the plans for that follow-up.