Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Retrospective Pharmacotherapeutic Evaluation of Dutasteride not Approved by US FDA for Androgenetic Alopecia in Korea

미국 식품의약국 미승인 두타스테라이드의 국내 남성형 탈모증 약물요법 적용에대한 후향적 평가

  • Cheon, Young Ju (College of Pharmacy, The Catholic University of Korea) ;
  • Kim, Jung Tae (Department of Pharmacy, Kyunghee University Hospital at Gang-dong) ;
  • Lim, Sung Cil (College of Pharmacy, The Catholic University of Korea)
  • 천영주 (가톨릭대학교 약학대학) ;
  • 김정태 (강동경희대학교병원 약제부) ;
  • 임성실 (가톨릭대학교 약학대학)
  • Received : 2015.07.17
  • Accepted : 2015.09.03
  • Published : 2015.09.30
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Abstract

Background: Androgenetic alopecia (AGA), one of alopecias, requires continuous treatment in order to prevent or stop it, and patient's compliance is very important. Currently, only two drugs (finasteride, minoxidil) have been approved for AGA by Food and Drug Administration of United States (US FDA). However, another ${\alpha}-2$ reductase inhibitor, dutasteride, is approved by Korea Ministry of Food and Drug Safety (MFDS) through a phase III trial. For treatment, pharmacotherapy of AGA usually combines topical minoxidil 7% with one of oral <${\alpha}-2$ reductase inhibitor. Objectives: We evaluated the comparative efficacy and adverse effect between topical minoxidil 7%/finasteride 1 mg and topical minoxidil 7%/dutasteride 0.5 mg pharmacotherapy for outpatients with AGA. Also we evaluated the relationship between therapeutic effect and regular hospital visit. Method: This study was performed retrospectively based on electronic medical record (EMR) data of total 98 patients (topical minoxidil 7% with dutasteride 0.5 mg ($Avodart^{(R)}$) or finasteride 1 mg ($Alopecia^{(R)}$, $Propecia^{(R)}$) with diagnosis of AGA from department of dermatology at a secondary hospital from January $1^{st}$, to May $31^{st}$, 2014. Results: The efficacy and adverse event of topical minoxidil 7%/dutasteride 0.5 mg (DUTA group) were 100% and 45.7%, and of topical minoxidil 7%/finasteride 1 mg (FINA group) were 92.1% and 33.3%, respectively. The mean onset time of responses and adverse events in the FINA group were 3.86 months and 4.43 months. Those in the DUTA group were 3.97 months and 5.06 months. Conclusion: Both FINA and DUTA group were highly effective, but the DUTA group showed higher efficacy and adverse effects than those in the FINA group. Dutasteride may be another alternative in AGA treatment.

Keywords

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