Combined Analysis of Two Multicenter Studies of Finasteride 5 mg in the Treatment of Symptomatic Benign Prostatic Hyperplasia

The document summarizes the results of two multicenter studies involving over 4500 men, which demonstrated that finasteride 5 mg is an effective and well-tolerated treatment for symptomatic benign prostatic hyperplasia (BPH). The studies, which lasted about 12 months, showed that finasteride significantly reduced urinary symptoms and prostate-specific antigen (PSA) levels across different age groups and ethnicities, with median PSA levels at the end of treatment being approximately half of the baseline values. The incidence of drug-related sexual adverse experiences was low, with 1.8% of patients withdrawing due to these effects. The incidence of prostate cancer and the need for surgical intervention were similar between the finasteride and placebo groups. The studies suggest that PSA values should be doubled after several months of finasteride therapy for accurate comparison to normal ranges in untreated men. However, the sample sizes for Black and Hispanic men were not large enough to draw definitive conclusions for these subgroups. The research was funded by Merck & Co., Inc.