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, that inhibits the conversion of testosterone (T) to dihydrote
stosterone (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 finasteride 5 mg, prostate volume, DHT
and prostate specific antigen (PSA) levels were reduced and maximum u
rinary flow rates and symptom scores were improved. Finasteride was we
ll tolerated. Upon completion of the controlled studies patients were
eligible to enter an open-label extension study in which all patients
received finasteride 5 mg. Approximately half of the 543 patients rand
omized to the finasteride 5 mg group in the controlled studies have no
w been treated with finasteride 5 mg continuously for 3 years. The dat
a provided by this group of patients on the long-term safety and effic
acy of finasteride in the treatment of symptomatic BPH are reviewed.