Background: In a previous study, dasotraline, a long-acting dopamine/norepinephrine reuptake inhibitor, demonstrated significant efficacy in treatment of binge-eating disorder (BED). We now report an analysis from this study of the effect of dasotraline on body weight.
Method: Patients with a DSM-5 diagnosis of BED were randomized to 12 weeks of double-blind, flexible-dose treatment with dasotraline (4-8 mg/d) vs. placebo. The primary efficacy outcome was number of binge-eating (BE) days/week. Mean change in weight at week 12 was analyzed by baseline BMI category.
Results: The safety population consisted of 317 patients. At baseline, the proportions of patients in each BMI category were as follows: normal ( < 25 kg/m2: 5.7%), overweight (25 to < 30 kg/m2: 18.3%), obesity class I (30 to < 35 kg/m2: 24.9%), class II (35 to < 40 kg/m2: 29.3%), and class III (≥40 kg/m2: 21.8%). For the overall patient sample, treatment with dasotraline significantly reduced the number of binge-eating days per week vs. placebo (-3.74 vs. -2.75; P < 0.0001; effect size = 0.74). In patients with obesity (classes I-III, combined), mean week 12 change in weight for completers treated with dasotraline vs. placebo was -6.2 vs. +0.3 kg, with ≥5% weight reduction observed in 59.3% vs. 4.2.1% of patients at week 12. Weight-related adverse events, for dasotraline vs. placebo, consisted of decreased appetite (19.7% vs. 6.9%) and decreased weight (12.1% vs. 0%).
Conclusion: Among BED patients treated with dasotraline, weight reduction ≥5% was observed in 45% of obese patients by week 12. The most frequent weight-related adverse event was decreased appetite.
This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.