Long-term (5-year) multinational experience with
finasteride 1 mg in the treatment of men with androgenetic alopecia.
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. 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.
PMID: 11809594 [PubMed - in process]