003   Long-Term (5 Years) Multinational Experience with Finasteride 1-mg in the Treatment of Men with Androgenetic Alopecia (Male Pattern Hair Loss)

Keith D. Kaufman, for The Finasteride Male Pattern Hair Loss Study Group, Merck Research Laboratories, Rahway, NJ, USA

We previously demonstrated the safety and efficacy of finasteride in the treatment of men with male pattern hair loss based on pooled 2-year data from two large, replicate, double-blind, placebo-controlled Phase III studies. The present analysis assessed the pooled long-term, placebo-controlled safety and efficacy data through 5 years in these studies. In two 1-year Phase III trials, 1553 men aged 18 to 41 years with male pattern hair loss were randomized to receive oral finasteride 1 mg/day or placebo for 1 year, and 1215 men continued in up to 4 consecutive, 1-year, placebo-controlled, blinded extension studies. Efficacy was evaluated by scalp hair counts, patient and investigator assessments, and global photographic assessment by an expert panel. Finasteride treatment led to improvements in scalp hair compared to baseline and placebo by all evaluation techniques during 5 years of treatment (p < 0.001 vs. placebo). Improvements in hair count (baseline = 876 hairs), measured in a 1-inch diameter circular area (5.1 cm 2 ) of balding vertex scalp, were observed with finasteride compared with placebo (difference of 126, 171, 183, 219 and 277 hairs at 1, 2, 3, 4 and 5 years, respectively; p < 0.001 for all between-group comparisons). Treatment with placebo led to progressive hair loss over 5 years. Patient self-assessment demonstrated that finasteride treatment led to improvements in hair growth, appearance of hair, and satisfaction with appearance of hair. These improvements were corroborated by the investigators’ assessments of patients. Global photographic assessments demonstrated the superiority of finasteride over placebo and confirmed that, without treatment, progressive visible hair loss occurs. Finasteride was generally well tolerated in the studies. Side effects were minimal and no new side effects were observed with increasing duration of exposure to finasteride. In men with male pattern hair loss, treatment with finasteride 1 mg/day was generally well tolerated and led to a durable reduction in the progression of hair loss and improvements in hair growth over 5 years.