A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder

Abstract

Background: A 12-month, open-label extension study assessed the long-term safety and tolerability of lisdexamfetamine dimesylate (LDX) in adults with binge eating disorder (BED).

Methods: Adults (aged 18-55 y) with BED who completed 1 of 3 antecedent studies were enrolled in a 52-week, open-label extension study (dose optimization, 4 weeks [initial titration dose, 30-mg LDX; target doses, 50- or 70-mg LDX]; dose maintenance, 48 weeks). Safety evaluations included the occurrence of treatment-emergent adverse events (TEAEs), vital sign and weight assessments, and Columbia-Suicide Severity Rating Scale responses.

Results: Of the 604 enrolled participants, 599 (521 women and 78 men) comprised the safety analysis set, and 369 completed the study. Mean (SD) LDX exposure was 284.3 (118.84) days; cumulative LDX exposure duration was 12 months or longer in 344 participants (57.4%). A total of 506 participants (84.5%) reported TEAEs (TEAEs leading to treatment discontinuation, 54 [9.0%]; severe TEAEs, 42 [7.0%]; serious TEAEs, 17 [2.8%]). Treatment-emergent adverse events reported in greater than or equal to 10% of participants were dry mouth (27.2%), headache (13.2%), insomnia (12.4%), and upper respiratory tract infection (11.4%). Mean (SD) changes from antecedent study baseline in systolic and diastolic blood pressure, pulse, and weight at week 52/early termination (n = 597) were 2.19 (11.043) and 1.77 (7.848) mm Hg, 6.58 (10.572) beats per minute, and -7.04 (7.534) kg, respectively. On the Columbia-Suicide Severity Rating Scale, there were 2 positive responses for any active suicidal ideations; there were no positive responses for suicidal behavior or completed suicides.

Conclusions: In this 12-month, open-label, extension study, the long-term safety and tolerability of LDX in adults with BED were generally consistent with its established profile for attention-deficit/hyperactivity disorder.

Figures

FIGURE 1

Change from baseline (Note: For vital sign changes, baseline refers to the antecedent study baseline [if enrollment gap was †DBP baseline, 76.32 (7.725) mm Hg (n = 599). ‡Pulse baseline, 72.18 (9.637) beats per minute (n = 599). §For change in body weight and percentage change in body weight, n = 529 at week 12, n = 516 at week 16, n = 387 at week 44, and n = 458 at follow-up.

FIGURE 2

Percentage (95% confidence interval [CI]) of improved* participants by treatment week on the CGI-I, FAS. *Participants categorized as improved on the CGI-I had scores of 1 (very much improved) or 2 (much improved); those who discontinued from the study for any reason before week 52 were categorized as not improved, which accounted for study attrition in the most conservative fashion. †Number of participants with a CGI-I assessment at the given treatment week (FAS, n = 597).