Treating benign prostatic hyperplasia with finasteride in Chinese men: one-year experience.

To evaluate the long-term efficacy and safety of finasteride in the treatment of symptomatic benign prostatic hyperplasia (BPH), 50 patients with symptomatic BPH were initially evaluated in a double blind, placebo-controlled study for 6 months. The patients were then treated with finasteride in an open extension study in which all received the same dose of finasteride (5 mg/day) for another 6 months. Among the patients (n = 23) who completed the extension study, prostate volume was significantly reduced from baseline by 15%, maximum urine flow rate improved by 1.9 mL/second, symptom scores improved by 37% and serum prostatic specific antigen (PSA) level decreased by 1.34 ng/mL. Other than serum PSA level, these data differed insignificantly from data at the end of the first 6 months. The adverse events observed at the end of the first 6 months (two patients with decreased sexual libido and two with impotency) persisted throughout the study extension period. At the end of the 12 months study, one more patient reported decreased libido. The sustained clinical efficacy and low incidence of side-effects of daily treatment with finasteride 5 mg for 1 year indicate that finasteride is safe and effective for managing symptomatic BPH in Chinese men.

RCT Entities:   Population Interventions Outcomes