PMID- 25587645
OWN - NLM
STAT- MEDLINE
DCOM- 20150608
LR  - 20220409
IS  - 2168-6238 (Electronic)
IS  - 2168-622X (Linking)
VI  - 72
IP  - 3
DP  - 2015 Mar
TI  - Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to 
      severe binge-eating disorder: a randomized clinical trial.
PG  - 235-46
LID - 10.1001/jamapsychiatry.2014.2162 [doi]
AB  - IMPORTANCE: Binge-eating disorder (BED), a public health problem associated with 
      psychopathological symptoms and obesity and possibly with metabolic syndrome, 
      lacks approved pharmacotherapies. OBJECTIVE: To examine the efficacy and safety 
      of lisdexamfetamine dimesylate, a dextroamphetamine prodrug, to treat moderate to 
      severe BED. DESIGN, SETTING, AND PARTICIPANTS: We performed a randomized, 
      double-blind, parallel-group, forced dose titration, placebo-controlled clinical 
      trial at 30 sites from May 10, 2011, through January 30, 2012. Safety and 
      intention-to-treat analyses included 259 and 255 adults with BED, respectively. 
      INTERVENTIONS: Lisdexamfetamine dimesylate at dosages of 30, 50, or 70 mg/d or 
      placebo were provided to study participants (1:1:1:1). Dosages were titrated 
      across 3 weeks and maintained for 8 weeks. We followed up participants for a mean 
      (SD) of 7 (2) days after the last dose. MAIN OUTCOMES AND MEASURES: We assessed 
      the change in binge-eating (BE) behaviors measured as days per week (baseline to 
      week 11) with a mixed-effects model using transformed log (BE days per week) + 1. 
      Secondary measures included BE cessation for 4 weeks. Safety assessments included 
      treatment-emergent adverse events, vital signs, and change in weight. RESULTS: At 
      week 11, log-transformed BE days per week decreased with the 50-mg/d (least 
      squares [LS] mean [SE] change, -1.49 [0.066]; P = .008) and 70-mg/d (LS mean [SE] 
      change, -1.57 [0.067]; P < .001) treatment groups but not the 30-mg/d treatment 
      group (LS mean [SE] change, -1.24 [0.067]; P = .88) compared with the placebo 
      group. Nontransformed mean (SD) days per week decreased for placebo and the 30-, 
      50-, and 70-mg/d treatment groups by -3.3 (2.04), -3.5 (1.95), -4.1 (1.52), and 
      -4.1 (1.57), respectively. The percentage of participants achieving 4-week BE 
      cessation was lower with the placebo group (21.3%) compared with the 50-mg/d 
      (42.2% [P = .01]) and 70-mg/d (50.0% [P < .001]) treatment groups. The incidence 
      of any treatment-emergent adverse events was 58.7% for the placebo group and 
      84.7% for the combined treatment group. In the treatment groups, 1.5% of 
      participants had serious treatment-emergent adverse effects. Events with a 
      frequency of at least 5% and changes in heart rate were generally consistent with 
      the known safety profile. The mean (SD) change in body weight was -0.1 (3.09), 
      -3.1 (3.64), -4.9 (4.43), -4.9 (3.93), and -4.3 (4.09) kg for the placebo group, 
      the 30-, 50-, and 70-mg/d treatment groups, and the combined treatment groups, 
      respectively (P < .001 for each dose vs placebo group comparison in post hoc 
      analysis). CONCLUSIONS AND RELEVANCE: The 50- and 70-mg/d treatment groups 
      demonstrated efficacy compared with the placebo group in decreased BE days, BE 
      cessation, and global improvement. The safety profile was generally consistent 
      with previous findings in adults with attention-deficit/hyperactivity disorder. 
      Further investigation of lisdexamfetamine in BED is ongoing. TRIAL REGISTRATION: 
      clinicaltrials.gov Identifier: NCT01291173.
FAU - McElroy, Susan L
AU  - McElroy SL
AD  - Research Institute, Lindner Center of HOPE, Mason, Ohio2Department of Psychiatry 
      and Behavioral Neuroscience, University of Cincinnati College of Medicine, 
      Cincinnati, Ohio.
FAU - Hudson, James I
AU  - Hudson JI
AD  - Department of Psychiatry, McLean Hospital/Harvard Medical School, Belmont, 
      Massachusetts.
FAU - Mitchell, James E
AU  - Mitchell JE
AD  - Neuropsychiatric Research Institute, Fargo, North Dakota5Department of 
      Neuroscience, University of North Dakota School of Medicine, Fargo.
FAU - Wilfley, Denise
AU  - Wilfley D
AD  - Department of Psychology, Washington University School of Medicine, St Louis, 
      Missouri.
FAU - Ferreira-Cornwell, M Celeste
AU  - Ferreira-Cornwell MC
AD  - Shire, Wayne, Pennsylvania.
FAU - Gao, Joseph
AU  - Gao J
AD  - Shire, Wayne, Pennsylvania.
FAU - Wang, Jiannong
AU  - Wang J
AD  - Shire, Wayne, Pennsylvania8currently with CSL Behring, King of Prussia, 
      Pennsylvania.
FAU - Whitaker, Timothy
AU  - Whitaker T
AD  - Shire, Wayne, Pennsylvania.
FAU - Jonas, Jeffrey
AU  - Jonas J
AD  - Shire, Wayne, Pennsylvania9currently with Sage Therapeutics, Cambridge, 
      Massachusetts.
FAU - Gasior, Maria
AU  - Gasior M
AD  - Shire, Wayne, Pennsylvania.
LA  - eng
SI  - ClinicalTrials.gov/NCT01291173
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JAMA Psychiatry
JT  - JAMA psychiatry
JID - 101589550
RN  - 0 (Dopamine Uptake Inhibitors)
RN  - SJT761GEGS (Lisdexamfetamine Dimesylate)
RN  - TZ47U051FI (Dextroamphetamine)
SB  - IM
MH  - Adult
MH  - Binge-Eating Disorder/*drug therapy
MH  - Dextroamphetamine/administration & dosage/adverse effects/*pharmacology
MH  - Dopamine Uptake Inhibitors/administration & dosage/adverse effects/*pharmacology
MH  - Double-Blind Method
MH  - Humans
MH  - Lisdexamfetamine Dimesylate
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2015/01/15 06:00
MHDA- 2015/06/09 06:00
CRDT- 2015/01/15 06:00
PHST- 2015/01/15 06:00 [entrez]
PHST- 2015/01/15 06:00 [pubmed]
PHST- 2015/06/09 06:00 [medline]
AID - 2089519 [pii]
AID - 10.1001/jamapsychiatry.2014.2162 [doi]
PST - ppublish
SO  - JAMA Psychiatry. 2015 Mar;72(3):235-46. doi: 10.1001/jamapsychiatry.2014.2162.