Impact of baseline symptom severity on future risk of benign prostatic hyperplasia-related outcomes and long-term response to finasteride

Objectives. To evaluate the long-term effects of finasteride on symptoms, a cute urinary retention (AUR), and the need for benign prostatic hyperplasia (BPH)-related surgery in relationship to baseline symptom severity. Methods. A total of 3040 men with BPH were treated for 4 years with finaste ride or placebo. The changes from baseline in symptoms and the incidence of BPH-related surgery and AUR were determined in men with mild (less than 8) , low-moderate (8 to 12), high-moderate (13 to 19), and severe (greater tha n 19) baseline quasi-American Urological Association symptoms for all patie nts and for the subgroup with a baseline prostate-specific antigen (PSA) le vel of 1.4 ng/mL or greater. Results. In patients who completed the 4-year study, the change in symptom score, stratified by baseline symptom severity, was +1.4 +/- 0.5 (mild), -0 .8 +/- 0.3 (low-moderate), -3.6 +/- 0.3 (high-moderate), and -7.7 +/- 0.5 ( severe) in finasteride-treated patients and, respectively, +3.4 +/- 0.5, +0 .7 +/- 0.3, -1.4 +/- 0.3, and -5.3 +/- 0.6 in placebo-treated patients (bet ween-group P <0.01). The between-group differences were greater in the subg roup of patients with a baseline PSA of 1.4 ng/mL or greater. The risk of B PH-related surgery increased among placebo patients with increasing baselin e symptom severity to a greater extent than the risk of AUR. Finasteride re duced the risk of AUR or the need for BPH-related surgery in all subgroups (P <0.001), especially in men with a baseline PSA of 1.4 ng/mL or greater. Conclusions. Compared with placebo, finasteride had a beneficial effect on symptoms, AUR, and BPH-related surgery in all symptom categories. BPH-relat ed surgery, but not AUR, occurred more commonly in placebo-treated men with more severe baseline symptoms. The greatest absolute benefit of finasterid e on symptoms and the reduction in risk of AUR and surgery was in men with higher baseline symptom scores and a baseline PSA level of 1.4 ng/mL or gre ater. UROLOGY 56: 610-616, 2000. (C) 2000, Elsevier Science Inc.