Long-term (5-year)
multinational experience with finasteride 1 mg in the treatment of men with
androgenetic alopecia.
Eur J Dermatol. 2002 Jan-Feb
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.
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.
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.
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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