title: Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia.
abstract: Androgenetic alopecia is an androgen-induced pattern of progressive hair loss, which occurs in genetically predisposed people. This study aimed to determine long-term safety, tolerability and efficacy of dutasteride 0.5 mg, an inhibitor of 5-α-reductase, in Japanese male patients with androgenetic alopecia. This was a multicenter, open-label, prospective outpatient study (clinicaltrials.gov NCT01831791, GSK identifier ARI114264) in which patients took dutasteride 0.5 mg p.o. once daily for 52 weeks. Primary end-points included adverse event assessment, incidence of drug-related adverse event and premature discontinuations. Secondary end-points included hair growth, hair restoration and global improvement in hair. A total of 120 patients were enrolled, of whom 110 completed 52 weeks of treatment. Nasopharyngitis, erectile dysfunction and decreased libido were the most frequently reported adverse events and most adverse events were mild. Drug-related adverse events were reported with an incidence of 17%, none of which led to study withdrawal. Hair growth (mean target area hair count at week 52), hair restoration (mean target area hair width at week 52) and global appearance of hair (mean of the median score at week 52) improved from baseline during the study. As a potential future treatment option for male androgenetic alopecia, dutasteride 0.5 mg exhibited long-term safety, tolerability and efficacy within this study population.
authors.affiliation: Yaesu Sakura-dori Clinic, Tokyo, Japan.|Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Tsunemi
authors.affiliation: ToCROM Clinic, Tokyo, Japan.|Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
authors.forename: Ryokichi
authors.initials: R
authors.lastname: Irisawa
authors.affiliation: PS Clinic, Fukuoka, Japan.|Akasaka Clinic, Fukuoka, Japan.
authors.forename: Hiromu
authors.initials: H
authors.lastname: Yoshiie
authors.affiliation: GlaxoSmithKline Research & Development, Research Triangle Park, North Carolina, USA.
authors.forename: Betsy
authors.initials: B
authors.lastname: Brotherton
authors.affiliation: GlaxoSmithKline Research & Development, Tokyo, Japan.
authors.forename: Hisahiro
authors.initials: H
authors.lastname: Ito
authors.affiliation: Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
authors.forename: Ryoji
authors.initials: R
authors.lastname: Tsuboi
authors.affiliation: Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Kawashima
authors.affiliation: GlaxoSmithKline Research & Development, Research Triangle Park, North Carolina, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Manyak
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000284:Administration, Oral; D000328:Adult; D000505:Alopecia / Q000188:drug therapy*; D000068538:Dutasteride / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006197:Hair / Q000187:drug effects* / Q000254:growth & development; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D000069451:Long Term Adverse Effects / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D058891:5-alpha Reductase Inhibitors; D000068538:Dutasteride
keywords: 5-alpha-reductase inhibitor; dihydrotestosterone; dutasteride; male androgenetic alopecia; safety