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| Long-term (5-year) multinational
experience with finasteride 1 mg in the treatment of men
with androgenetic alopecia. |
- Eur J Dermatol 2002 Jan-Feb;12(1):38-49 (ISSN: 1167-1122)
Collective Name: The Finasteride Male Pattern Hair Loss Study
Group.
- BACKGROUND: Finasteride 1 mg (Propecia) is indicated
for the treatment of men with androgenetic alopecia (male
pattern hair loss, MPHL). However, the long-term (> 2 years)
efficacy and safety of finasteride in this population has
not been previously reported. Objectives. To assess the efficacy
and safety of finasteride in men with MPHL compared to treatment
with placebo over five years.
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- METHODS: In two 1-year, Phase III trials, 1,553 men
with MPHL were randomized to receive finasteride 1 mg/day
or placebo, and 1,215 men continued in up to four 1-year,
placebo-controlled extension studies. Efficacy was evaluated
by hair counts, patient and investigator assessments, and
panel review of clinical photographs.
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- RESULTS: Treatment with finasteride led to durable
improvements in scalp hair over five years (p 3/4 0.001 versus
placebo, all endpoints), while treatment with placebo led
to progressive hair loss. Finasteride was generally well tolerated
and no new safety concerns were identified during long-term
use.
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- CONCLUSIONS: In men with MPHL, long-term treatment
with finasteride 1 mg/day over five years was well tolerated,
led to durable improvements in scalp hair growth, and slowed
the further progression of hair loss that occurred without
treatment.
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