PMID- 27489426
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160804
LR  - 20201001
IS  - 1013-9087 (Print)
IS  - 2005-3894 (Electronic)
IS  - 1013-9087 (Linking)
VI  - 28
IP  - 4
DP  - 2016 Aug
TI  - Safety and Tolerability of the Dual 5-Alpha Reductase Inhibitor Dutasteride in 
      the Treatment of Androgenetic Alopecia.
PG  - 444-50
LID - 10.5021/ad.2016.28.4.444 [doi]
AB  - BACKGROUND: After the approval of dutastride for androgenic alopecia (AGA) in 
      2009, Korean authority required a post-marketing surveillance to obtain further 
      data on its safety profile. OBJECTIVE: The objective was to monitor adverse 
      events (AEs) of dutasteride 0.5 mg in Korean AGA male patients in a clinical 
      practice environment. METHODS: Open label, multi-center, non-interventional 
      observational study was done from July 2009 to July 2013. AGA subjects (18~41 
      years of age) with no experience of dutasteride were enrolled. Dosage regimen was 
      recommended according to the prescribing information. The incidences of any AEs, 
      serious adverse events (SAEs), and adverse drug reactions (ADRs) were evaluated. 
      Multiple logistic regression method was used to identify risk factors related to 
      ADRs. Effectiveness was generally evaluated by physicians. RESULTS: During study 
      period, 712 subjects were enrolled. The subjects of 29.3+/-6.0 years old exposed to 
      dutasteride for 204.7+/-161.5 days. One hundred and ten (15.4%) of subjects 
      reported 138 AEs. Four subjects (0.6%) reported 5 SAEs (right radius fracture, 2 
      events of chronic follicular tonsillitis, influenza infection, and acute 
      appendicitis). Sixty-six subjects (9.3%) reported 80 ADRs. Most frequent ADRs 
      were libido decreased (9 subjects, 1.3%), dyspepsia (8 subjects, 1.1%), impotence 
      (7 subjects, 1.0%), and fatigue (5 subjects, 0.7%). Other interested ADRs were 
      sexual function abnormality (4 subjects, 0.6%), gynecomastia (2 subjects, 0.3%), 
      and ejaculation disorder (1 subject, 0.1%). Most subjects (78.6%) showed overall 
      improvement after treatment of dutasteride in the effectiveness. CONCLUSION: 
      Dutasteride 0.5 mg is to be well-tolerated in 18 to 41 years old AGA patients in 
      a clinical practice environment.
FAU - Choi, Gwang Seong
AU  - Choi GS
AD  - Department of Dermatology, Inha University College of Medicine, Incheon, Korea.
FAU - Kim, Joon Hyung
AU  - Kim JH
AD  - GlaxoSmithKline, Seoul, Korea.
FAU - Oh, Shin-Young
AU  - Oh SY
AD  - GlaxoSmithKline, Seoul, Korea.
FAU - Park, Jung-Min
AU  - Park JM
AD  - GlaxoSmithKline, Seoul, Korea.
FAU - Hong, Ji-Soo
AU  - Hong JS
AD  - GlaxoSmithKline, Seoul, Korea.
FAU - Lee, Yil-Seob
AU  - Lee YS
AD  - GlaxoSmithKline, Seoul, Korea.
FAU - Lee, Won-Soo
AU  - Lee WS
AD  - Department of Dermatology and Institute of Hair & Cosmetic Medicine, Yonsei 
      University Wonju College of Medicine, Wonju, Korea.
LA  - eng
PT  - Journal Article
DEP - 20160726
PL  - Korea (South)
TA  - Ann Dermatol
JT  - Annals of dermatology
JID - 8916577
PMC - PMC4969473
OTO - NOTNLM
OT  - Alopecia
OT  - Drug-related side effects and adverse reactions
OT  - Dutasteride
OT  - Product surveillance
OT  - Safety
OT  - Treatment outcome
OT  - postmarketing
COIS- Conflict of interest: Yil-Seob Lee and Joon Hyung Kim are employees of 
      GlaxoSmithKline and have stock/stock options in the company. Any other potential 
      conflict of interest relevant to this article was not reported.
EDAT- 2016/08/05 06:00
MHDA- 2016/08/05 06:01
PMCR- 2016/08/01
CRDT- 2016/08/05 06:00
PHST- 2014/06/23 00:00 [received]
PHST- 2015/05/29 00:00 [revised]
PHST- 2015/10/12 00:00 [accepted]
PHST- 2016/08/05 06:00 [entrez]
PHST- 2016/08/05 06:00 [pubmed]
PHST- 2016/08/05 06:01 [medline]
PHST- 2016/08/01 00:00 [pmc-release]
AID - 10.5021/ad.2016.28.4.444 [doi]
PST - ppublish
SO  - Ann Dermatol. 2016 Aug;28(4):444-50. doi: 10.5021/ad.2016.28.4.444. Epub 2016 Jul 
      26.