MIAMI — In two randomized controlled trials in adults with binge eating disorder (BED), lisdexamfetamine (Vyvanse, Shire) (LDX) acted faster and achieved superior improvement in binge eating behavior, body weight, and psychopathology related to the obsessive-compulsive features of BED compared with placebo.

"LDX should be tried in people who suffer from this disorder," lead author Susan McElroy, MD, from the Lindner Center of Hope, in Mason, Ohio, and the University of Cincinnati, told Medscape Medical News.

"LDX is the first drug to be approved by the FDA for the treatment of binge eating disorder, and I hope that more people with the disorder will feel comfortable talking about their symptoms with their healthcare providers and that they will get treatment. Binge eating disorder is an important health problem. It can cause chronic illness, such as diabetes, so I hope these results will help increase awareness that treatment is possible," Dr McElroy said here at the American Society of Clinical Psychopharmacology (ASCP) 2015 Annual Meeting.

The two studies included a total of 724 adults meeting DSM-IV-TR criteria for BED. In study 1, 184 participants were randomly assigned to receive placebo, and 190 participants received LDX. In study 2, 176 participants were randomly assigned to receive placebo, and 174 participants received LDX.

The dose of LDX ranged from 50 to 70 mg/day in both studies, which lasted 12 weeks.

The patients were assessed with the Clinical Global Impressions–Improvement (CGI-I) scale, a clinician-rated measure of global improvement in disease severity relative to baseline, in which 1 equals very much improved and 7 = very much worse. Assessments with the CGI-I were made at each visit after study entry.

The number of binge eating episodes per week was determined from diaries that were kept by the participants.

Body weight was measured at each visit, and the Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCES-BE), a 10- item clinician-rated scale assessing the obsessiveness of binge eating thoughts and compulsiveness of binge eating behaviors, was administered at baseline and at weeks 4, 8, and 12, or if the patient terminated the study early.

A greater percentage of patients receiving LDX showed improvement on the CGI-I score at weeks 1 to 10 compared with those receiving placebo in both studies (1.23% for placebo vs 47.9% for LDX in study 1, and 21.8% for placebo vs 39.3% for LDX in study 2).

By week 12, the difference was statistically significant for LDX-treated patients in both studies (47.3% for placebo vs 82.1% for LDX in study 1, and 42.9% for placebo vs 86.2% for LDX in study 2; P < .001 for both studies).

Weekly episodes of binge eating were also less in patients receiving LDX compared with those receiving placebo from week 1 through weeks 11 to 12 in both studies. For study 1, the least square mean difference (LSMD) was -1.77 (95% confidence interval [CI], -2.24 to -1.30); and for study 2, the LSMD was -2.23 (95% CI, -2.77 to -1.69; P < .001 for both).

Patients receiving LDX lost more weight than those receiving placebo during weeks 1 to 2; this loss achieved statistical significance by week 12.

The LSMD in percent change from baseline body weight was -6.35 (95% CI, -7.17 to -5.54) in study 1, and -5.41 (95% CI -6.39 to - 4.44) in study 2 (P < .001 for both).

Binge eating thoughts and compulsiveness, as measured by the Y-BOCS-BE scale, were also reduced more when for patients receiving LDX than for those receiving placebo.

The LSMD by week 12 was -7.40 (95% CI, -8.93 to -5.88) for study 1, and -7.94 (95% CI, -9.51 to -6.36) for study 2 (P < .001 for both studies).

"We got drug placebo separation on all of the important endpoints. We started to see improvement and reductions in binge eating behavior, body weight, and obsessive compulsive features of binge eating as early as the first week with lisdexamfetamine, and this better result was maintained throughout the duration of both of the studies," Dr McElroy said.

"Clearly, this is an effective drug for some people with BED. It has been problematic to treat these patients in the past because it is a secret condition. People are profoundly ashamed of binge eating. They feel powerless to control it, and so the diagnosis of BED is underrecognized. Yet it is the most common eating disorder; it is more common than anorexia and bulimia combined. Treatment of BED has also not been well studied, and while cognitive-behavioral therapy is effective for some, many patients will require pharmacotherapy," she said.

A Word of Caution

Commenting on this study for Medscape Medical News, Alan J. Gelenberg, MD, professor emeritus of psychiatry at the University of Arizona, in Tucson, noted a word of caution about interpreting the results.

Dr Alan Gelenberg

"This poster presents a secondary analysis of combined data from two positive trials of this industry-funded trial of a medication, the first approved by FDA for BED," Dr Gelenberg said. "The two studies were straightforward."

"When there is only one approved treatment, and it is a proprietary agent, I believe psychiatry must be cautious about declaring a new diagnosis a big public health problem with an unmet need. It may be, but to be sensitive to public perceptions, we must await studies of BED by independent investigators unaffiliated with commercial entities," he said.

The study was funded by Shire Development LLC. Dr McElroy reports financial relationships with Bracket, F. Hoffmann-La Roche, MedAvante, Naurex, Novo Nordisk, Shire, Sunovion, the Agency for Healthcare Research and Quality, Alkermes, Cephalon, Forest, Marriott Foundation, National Institute of Mental Health, Naurex, Orexigen Therapeutics, Shire, Takeda Pharmaceutical Company Limited, United States patent no. 6,323,236 B2 for use of sulfamate derivatives for treating impulse control disorders, and Johnson & Johnson Pharmaceutical Research and Development LLC. Dr Gelenberg reports financial relationships with Allergan, Forest, Pfizer, and Healthcare Technology Systems.

American Society of Clinical Psychopharmacology (ASCP) 2015 Annual Meeting. Abstract 3000237. Presented June 24, 2015.


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