title: 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.
authors.affiliation: *Formerly of Shire, Lexington, MA; †McLean Hospital/Harvard Medical School, Belmont, MA; ‡Hospital Universitario Infanta Leonor, Madrid, Spain; §Lindner Center of HOPE, Mason; and ∥University of Cincinnati College of Medicine, Cincinnati, OH.
authors.forename: Maria
authors.initials: M
authors.lastname: Gasior
authors.forename: James
authors.initials: J
authors.lastname: Hudson
authors.forename: Javier
authors.initials: J
authors.lastname: Quintero
authors.forename: M Celeste
authors.initials: MC
authors.lastname: Ferreira-Cornwell
authors.forename: Jana
authors.initials: J
authors.lastname: Radewonuk
authors.forename: Susan L
authors.initials: SL
authors.lastname: McElroy
mesh_terms: D000293:Adolescent; D000328:Adult; D056912:Binge-Eating Disorder / Q000188:drug therapy*; D018765:Dopamine Uptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D055815:Young Adult
chemical_list: D018765:Dopamine Uptake Inhibitors; D000069478:Lisdexamfetamine Dimesylate