Binge-Eating Medication Found Effective as Maintenance Therapy
Abstract
A six-month maintenance study found that only 3 percent of patients relapsed if they continued taking Vyvansase (lisdexamfetamine) after their acute symptoms had been controlled.
A multinational clinical study of adults with binge-eating disorder (BED) has found that Vyvanase (lisdexamfetamine) is significantly more effective than placebo at preventing relapse of binge-eating symptoms over a six-month period. Only 3.7 percent of the participants taking lisdexamfetamine experienced relapse during the study period compared with about 32 percent of patients taking placebo.
“This is a striking maintenance effect,” said lead study author James Hudson, M.D., Sc.D., head of the Biological Psychiatry Laboratory at McLean Hospital in Boston. “Not only for how few people relapsed on medication, but also for the large degree of separation between the drug and placebo groups; this is far greater than typically seen in neuropsychiatric studies,” he told Psychiatric News.
This first-ever controlled trial of maintenance lisdexamfetamine involved 418 adults with moderate-to-severe BED, defined as at least three binge-eating days per week, and a Clinical Global Impression-Severity (CGI-S) score of 4 or higher. All the participants received 12 weeks of lisdexamfetamine therapy (50 mg or 70 mg once daily, depending on the patient’s ability to tolerate the dose) to control their acute symptoms.
Participants who responded to lisdexamfetamine—defined as having one or fewer binge-eating days per week for at least four weeks and a CGI-S score of 2 or lower—were then moved to the maintenance phase. They were then randomly assigned to continue the lisdexamfetamine regimen or receive placebo for 26 more weeks to assess relapse.
Relapse was defined as the occurrence of two or more binge-eating days per week for two consecutive weeks and a 2 or more point increase in CGI-S scores. A total of 42 of 131 participants on placebo met relapse criteria compared with 5 of 136 participants in the lisdexamfetamine group.
“Individuals with BED who respond initially to lisdexamphetamine and stop using the medication following symptom resolution appear to have a 32 percent risk of relapse,” said Evelyn Attia, M.D., director of the Center for Eating Disorders at New York Presbyterian Hospital. Attia was not involved with the study.
“It remains notable that two-thirds of the sample who initially responded to, and then discontinued the medication, remain improved following medication discontinuation,” she continued. “This is consistent with the high placebo response rates reported in many previous BED treatment studies, and suggests that non-specific factors appear to contribute significantly to good outcome in BED.”
Knowing the best time to discontinue treatment for BED once symptoms subside can be challenging, as much like depression, BED comes and goes in terms of symptomatic episodes, Hudson explained. These episodes are disruptive and distressing to the patient, and Hudson said that he believes it is prudent to be over-cautious and maximize the chance of stability.
“The symptoms of BED go away quickly, but it takes a while for a patient to feel normal again,” he said. “The binge eating is just the tip of the iceberg; these patients feel a true loss of control over themselves.”
Hudson said that once symptoms are managed, BED patients need time to see their life in a healthy manner and reorganize their eating habits with the aid of psychological tools.
While the current analysis was limited to a six-month follow-up, the results of a year-long open-label study suggest the benefits of maintenance lisdexamfetamine may last longer.
This study was supported by Shire Development LLC, manufacturer of Vyvanase. The study authors have financial ties to the company. ■
