Effects of doxazosin in patients with mild, intermediate, and severe benign prostatic hyperplasia.

Traditionally, drug therapy for benign prostatic hyperplasia (BPH) has been reserved for patients with mild or moderate symptoms. The objective of this analysis was to compare responses to an alpha 1-adrenergic receptor blocker, doxazosin, in patients with severe, intermediate, and mild disease. Data were analyzed from patients with symptomatic BPH who were enrolled in two 16-week, double-masked, placebo-controlled studies of doxazosin. In study 1, 163 hypertensive patients were stratified according to baseline maximum (Qmax) and mean (Qmean) urinary flow rate as having severe, intermediate, or mild disease. In study 2, 82 normotensive patients were stratified according to their baseline American Urological Association (AUA) BPH symptom severity score and modified Boyarsky symptom bothersomeness score. Overall, doxazosin was significantly more effective than placebo in improving Qmax and Qmean in study 1 and in improving the AUA-derived and modified Boyarsky scores in study 2. There were statistically significant differences in the response to treatment, as represented by Qmax' Qmean, and modified Boyarsky score, between patients with severe, intermediate, and mild disease. There were no significant differences in the AUA-derived scores of patients in the three severity groups. These results have important clinical implications, suggesting that the majority of BPH patients are candidates for a course of drug therapy, regardless of baseline disease status.