PMID- 25752762
OWN - NLM
STAT- MEDLINE
DCOM- 20161108
LR  - 20220316
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Linking)
VI  - 69
IP  - 4
DP  - 2015 Apr
TI  - Lisdexamfetamine for binge eating disorder in adults: a systematic review of the 
      efficacy and safety profile for this newly approved indication - what is the 
      number needed to treat, number needed to harm and likelihood to be helped or 
      harmed?
PG  - 410-21
LID - 10.1111/ijcp.12639 [doi]
AB  - OBJECTIVE: To describe the efficacy and safety of lisdexamfetamine dimesylate 
      (LDX) for the treatment of binge eating disorder (BED). DATA SOURCES: The pivotal 
      registration trials were accessed by querying 
      http://www.ncbi.nlm.nih.gov/pubmed/, http://www.clinicaltrials.gov and 
      http://www.clinicaltrialsregister.eu for the search terms 'lisdexamfetamine' and 
      'binge', and by also querying the Web of Science (Thomson Reuters) and Embase 
      (Elsevier) commercial databases, and by asking the manufacturer for copies of 
      posters presented at congresses. Product labelling provided additional 
      information. STUDY SELECTION: All available clinical reports of studies were 
      identified. DATA EXTRACTION: Descriptions of the principal results and 
      calculation of number needed to treat (NNT) and number needed to harm (NNH) for 
      relevant dichotomous outcomes were extracted from the available study reports and 
      other sources of information. DATA SYNTHESIS: LDX is a central nervous system 
      stimulant indicated for the treatment of moderate to severe BED. The recommended 
      dose range is 50-70 mg/day. Approval for the treatment of BED was based on a 
      clinical development programme that included an 11-week Phase II 
      proof-of-concept, placebo-controlled study, testing fixed doses of LDX 30, 50 and 
      70 mg/day, and two 12-week Phase III placebo-controlled studies examining LDX 
      50-70 mg/day. Statistically significant reductions in binge eating days/week, the 
      primary outcome measure, were observed for LDX doses of 50 and 70 mg/day, with 
      effect sizes in the Phase III trials ranging from 0.83 to 0.97. The pooled NNT 
      for response across all trials (as defined by a Clinical Global 
      Impressions-Improvement score of 'very much improved' or 'much improved') for LDX 
      vs. placebo was 3 (95% CI 3-4), and NNT for remission (as defined by 4-week 
      cessation of binge eating) for LDX vs. placebo was 4 (95% CI 4-6). Reductions in 
      weight ranged between 5.2% and 6.25% for LDX 50 or 70 mg/day. Discontinuation 
      rates because of adverse events (AEs) were low; NNH for discontinuation because 
      of an AE for LDX vs. placebo was 44 (95% CI 23-1971). The most commonly 
      encountered AEs (incidence >/= 10% and greater than the rate for placebo) were dry 
      mouth, decreased appetite, insomnia and headache, with NNH values vs. placebo of 
      4 (95% CI 3-5), 11 (95% CI 8-17), 11 (95% CI 8-18) and 19 (95% CI 11-75), 
      respectively. CONCLUSIONS: LDX is the first pharmacological agent that has 
      received regulatory approval for the treatment of BED. LDX 50 or 70 mg/day 
      significantly reduced BED symptoms as measured by the number of binge eating days 
      per week. Effect sizes were highly robust. Pending clinical trials include a 
      long-term study examining maintenance of efficacy.
CI  - (c) 2015 John Wiley & Sons Ltd.
FAU - Citrome, L
AU  - Citrome L
AD  - Department of Psychiatry & Behavioral Sciences, New York Medical College, 
      Valhalla, NY, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20150306
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Dopamine Uptake Inhibitors)
RN  - SJT761GEGS (Lisdexamfetamine Dimesylate)
SB  - IM
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Binge-Eating Disorder/*drug therapy
MH  - Central Nervous System Stimulants/adverse effects/*therapeutic use
MH  - Clinical Trials as Topic
MH  - Dopamine Uptake Inhibitors/adverse effects/*therapeutic use
MH  - Humans
MH  - Lisdexamfetamine Dimesylate/adverse effects/*therapeutic use
MH  - Numbers Needed To Treat
EDAT- 2015/03/11 06:00
MHDA- 2016/11/09 06:00
CRDT- 2015/03/11 06:00
PHST- 2015/01/31 00:00 [received]
PHST- 2015/02/10 00:00 [accepted]
PHST- 2015/03/11 06:00 [entrez]
PHST- 2015/03/11 06:00 [pubmed]
PHST- 2016/11/09 06:00 [medline]
AID - 10.1111/ijcp.12639 [doi]
PST - ppublish
SO  - Int J Clin Pract. 2015 Apr;69(4):410-21. doi: 10.1111/ijcp.12639. Epub 2015 Mar 
      6.