Benign prostatic hyperplasia (BPH) is a disease diagnosed by the prese
nce of prostatic enlargement and lower-tract urinary obstruction. Fina
steride (Proscar(R)), is a potent and specific inhibitor of 5 alpha-re
ductase, which inhibits the conversion of testosterone (T) to dihydrot
estosterone (DHT) an important promoter of prostatic growth. It has pr
ovided a new therapeutic alternative for the treatment of BPH. The saf
ety and efficacy of finasteride in the treatment of symptomatic BPH ha
ve been demonstrated by two multicenter placebo-controlled studies. Af
ter 12 months of treatment with 5 mg finasteride daily, prostate volum
e, DHT and prostate-specific antigen (PSA) levels were reduced and max
imum urinary flow rates and symptom scores were improved. Finasteride
was well-tolerated. Upon completion of the controlled studies, patient
s were eligible to enter an open-label extension study in which all pa
tients received 5 mg finasteride. Approximately half of the 543 patien
ts randomized to the 5 mg finasteride group in the controlled studies
have now been treated with 5 mg finasteride continuously for 3 years.
The data provided by this group of patients on the long-term safety an
d efficacy of finasteride in the treatment of symptomatic BPH are revi
ewed. (C) 1996 Wiley-Liss, Inc.