Finasteride is a standard medical treatment for androgenetic alopecia; however, no long-term study of up to 10 years has been performed in Japan. Therefore, we evaluated the efficacy and safety of 1 mg/day finasteride in 532 Japanese men who were treated for androgenetic alopecia for 10 years. We performed subjective evaluations, using questionnaires administered to patients, in addition to the objective evaluation by doctors. The efficacy was assessed using the Norwood-Hamilton scale and modified global photographic assessment score, the standardized 7-point rating score using scalp photographs. For the Norwood-Hamilton classifications, stages IIa and IIv were combined as II, IIIa and IIIv were combined as III, IVa was combined as IV, and Va was combined as V. The proportions of patients with improvement (score ≥ 5) and prevention of disease progression (score ≥ 4) were 91.5% and 99.1%, respectively. The Norwood-Hamilton classification grading improved by approximately 1 grade from 3.35 ± 1.11 to 2.55 ± 1.30 after the 10-year treatment. The groups that showed Norwood-Hamilton: I/II/III and IV/V/VI/ VII at the first visit showed statistically significant differences in the modified global photographic assessment score at the 10-year treatment subjective evaluation (6.27 ± 0.62 vs 5.52 ± 0.78, P<0.001). Furthermore, the quantitative analysis of the objective evaluation using the questionnaire was also significantly different (P<0.001). During the study period, no serious adverse reaction was recognized. Long-term (10-year) treatment with 1 mg/day finasteride in Japanese men with androgenetic alopecia showed high efficacy in subjective and objective evaluations.
Introduction: Finasteride has been the standard medical treatment for androgenetic alopecia (AGA) for over 20 years. We started AGA treatment with finasteride in 1999 in Japan, and have demonstrated 3 investigations as long-term and/or largescale studies (3,177 cases in 2.5 years, 801 cases in 5 years, 532 cases in 10 years, respectively). The objective of this study is to summarize the three investigations, and to consider it as a base for future studies over the next 20 to 30 or more years.Methods: Vertex photographs and/or forehead photographs were taken and recorded for every patient at each examination and used for evaluation for more than 20 years. Efficacy was assessed using the Norwood-Hamilton scale (N-H) and the modified global photographic assessment (MGPA) score, which is the standardized 7-point rating score using scalp photographs. Adverse reactions were assessed through self-reported evaluations by patients in two investigationsResults: All three of the investigations demonstrated high evaluations of improvement (MGPA≧5; 87.1%, 99.4%, and 91.5%, respectively), and higher evaluations of prevention of disease progression (MGPA≧4; 99.6%, 100%, and 99.1%, respectively). Furthermore, the early-stage AGA group (N-H I-III at first visit) and the younger group (less than 40 years of age at first visit) showed more improvement with long-term AGA treatment with finasteride than the other groups did. Two of the investigations showed safety of long-term AGA treatment with finasteride, revealing the low onset rates of adverse reactions (adverse reactions: 0.7% in 2.5 years and 6.8% in 10 years, respectively). Neither of the two investigations recognized Post Finasteride Syndrome adverse reaction at all.Conclusion: Long-term (greater than 10 years) AGA treatment with finasteride 1mg/day demonstrated a high efficacy and safety based on large-scale studies in Japanese men. For patients at the early stage of classification of AGA (within N-H I-III or earlier) and/or younger than 40 years of age, we recommend starting treatment with 1mg/day finasteride.
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