Study Finds Lisdexamfetamine Dimesylate Decreases Binge-Eating Episodes

A recent study found that treatment with lisdexamfetamine dimesylate led to a decrease in binge-eating days for patients with binge-eating disorder (BED) compared with placebo [JAMA Psychiatry. 2015; DOI:10.1001/jamapsychiatry.2014.2162].

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BED is gaining recognition as a serious public health problem that is associated with obesity and psychiatric comorbidities, including depression, and may be predictive of metabolic syndrome.

BED is characterized by recurrent episodes of excessive food consumption accompanied by a sense of loss of control and psychological distress but without the compensatory weight loss behaviors of bulimia.

Many patients remain undertreated for BED. When this study was conducted, no treatments were FDA-approved to treat BED.

This multicenter, randomized, double-blind, parallel-group, forced dose titration, placebo-controlled clinical trial was conducted to examine the efficacy and safety of lisdexamfetamine to treat moderate to severe BED.

The study took place at 28 sites between May 10, 2011, and January 30, 2012. Patients were included in the study if they were 18 to 55 years of age and met the criteria for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition. Patients also needed to have a body mass index between 25 kg/m2 and 45 mg/m2. Patients were excluded from the study if they had bulimia, anorexia, attention deficit/hyperactivity disorder, or another psychiatric disorder.

The primary efficacy measure was the number of binge-eating days per week based on clinician interview and confirmation of identified binge-eating episodes via a self-reported diary. The primary end point was the change from baseline to week 11 on binge-eating days per week.

Safety and intention-to-treat analyses included 259 and 255 adults with BED, respectively.

Patients were randomized to receive placebo or lisdexamfetamine 30 mg, 50 mg, or 70 mg. Lisdexamfetamine doses were titrated across 3 weeks and then maintained for 8 weeks. Patients were followed-up for a mean of 7 days after the final dose of treatment.

After 11 weeks, a decrease in binge-eating days per week was seen in the 50 mg lisdexamfetamine group (least squares mean change, –1.49; P=.008) and the 70 mg lisdexamfetamine group (least squares mean change, –1.57; P<.001), though no change was seen in the 30 mg lisdexamfetamine group (least squares mean change, –1.24; P<.88) compared with placebo.

Nontransformed mean days per week decreased for placebo and the 30 mg, 50 mg, and 70 mg cohorts by –3.33, –3.5, –4.1, and –4.1, respectively.

The percentage of patients achieving 4-week binge-eating cessation was lower in the placebo group (21.3%) compared with the lisdexamfetamine 50 mg and 70 mg treatment groups (42.2%, P=.01 and 50%, P<.001, respectively).

The incidence of treatment-emergent adverse events was 58.7% in the placebo group and 84.7% for the lisdexamfetamine cohorts. The researchers noted that adverse events with a frequency of at least 5% and changes in heart rate were generally consistent with the known safety profile of lisdexamfetamine.

The researchers noted that lisdexamfetamine is a schedule 2 drug that carries a Black Box Warning indicating the potential for abuse and dependence.

The researchers also noted study limitations, including that most participants were female, white, non-Hispanic, and overweight or obese. In addition, patients with comorbid illnesses were excluded, all of which limits the generalizability of the study’s findings.

The researchers concluded that lisdexamfetamine is “a treatment option for decreasing binge-eating behavior and the binge-eating associated obsessive compulsive features in adults with moderate to severe BED.”—Kerri Fitzgerald