PMID- 23890583
OWN - NLM
STAT- MEDLINE
DCOM- 20140513
LR  - 20201206
IS  - 1573-2517 (Electronic)
IS  - 0165-0327 (Linking)
VI  - 151
IP  - 2
DP  - 2013 Nov
TI  - Placing transdermal selegiline for major depressive disorder into clinical 
      context: number needed to treat, number needed to harm, and likelihood to be 
      helped or harmed.
PG  - 409-417
LID - S0165-0327(13)00507-7 [pii]
LID - 10.1016/j.jad.2013.06.027 [doi]
AB  - BACKGROUND: This is a quantitative review of existing studies of transdermal 
      selegiline for major depressive disorder. METHODS: Data for dichotomous outcomes 
      were extracted from the five 6-8 week studies of transdermal selegiline. Number 
      needed to treat (NNT) vs. placebo was calculated for response and remission using 
      standard definitions. Number needed to harm (NNH) vs. placebo for commonly 
      encountered adverse events (AEs), AEs associated with sexual function, incidence 
      of weight gain >/=5% from baseline, and discontinuation due to an AE, were also 
      calculated. Data was pooled as appropriate and likelihood to be helped or harmed 
      (LHH) ratios contrasting remission with selected tolerability outcomes were 
      determined. RESULTS: When pooling together the two pivotal trials as identified 
      in product labeling, NNT for response was 11 (95% CI 6-109) and for remission, 9 
      (95% CI 6-28). Pooling all trials, NNH for application site reaction was 7 (95% 
      CI 6-10) and for insomnia, 19 (95% CI 12-41). There were no clinically relevant 
      differences from placebo regarding weight gain or impairment in sexual 
      functioning. NNH for discontinuation due to an AE was 32 (95% CI 19-132). LHH for 
      remission vs. discontinuation from treatment due to an AE was 3.6. LIMITATIONS: 
      The studies included were not identical in design. The studies were 
      registrational in nature and thus not necessarily generalizable. CONCLUSIONS: NNT 
      for transdermal selegiline for efficacy is similar to that for other 
      antidepressant regimens for which similar analyses have been published. There 
      appear to be no clinically relevant effects of selegiline on weight or sexual 
      functioning.
CI  - (c) 2013 Elsevier B.V. All rights reserved.
FAU - Citrome, Leslie
AU  - Citrome L
AD  - New York Medical College, Valhalla, NY, USA. Electronic address: 
      nntman@gmail.com.
FAU - Goldberg, Joseph F
AU  - Goldberg JF
AD  - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
FAU - Portland, Kimberly Blanchard
AU  - Portland KB
AD  - Mylan Specialty L.P., Basking Ridge, NJ, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20130724
PL  - Netherlands
TA  - J Affect Disord
JT  - Journal of affective disorders
JID - 7906073
RN  - 0 (Antidepressive Agents)
RN  - 2K1V7GP655 (Selegiline)
SB  - IM
MH  - Administration, Cutaneous
MH  - Antidepressive Agents/*administration & dosage
MH  - Biomedical Research
MH  - Depressive Disorder, Major/*drug therapy
MH  - Humans
MH  - Randomized Controlled Trials as Topic
MH  - Research Design
MH  - Selegiline/*administration & dosage
OTO - NOTNLM
OT  - Evidence-based medicine
OT  - Major depressive disorder
OT  - Number needed to harm
OT  - Number needed to treat
OT  - Selegiline
OT  - Transdermal
EDAT- 2013/07/31 06:00
MHDA- 2014/05/14 06:00
CRDT- 2013/07/30 06:00
PHST- 2013/04/11 00:00 [received]
PHST- 2013/05/13 00:00 [revised]
PHST- 2013/06/14 00:00 [accepted]
PHST- 2013/07/30 06:00 [entrez]
PHST- 2013/07/31 06:00 [pubmed]
PHST- 2014/05/14 06:00 [medline]
AID - S0165-0327(13)00507-7 [pii]
AID - 10.1016/j.jad.2013.06.027 [doi]
PST - ppublish
SO  - J Affect Disord. 2013 Nov;151(2):409-417. doi: 10.1016/j.jad.2013.06.027. Epub 
      2013 Jul 24.