The safety, efficacy and compliance of terazosin therapy for benign prostatic hyperplasia.

The primary objective of the present interim analysis of an open label study initiated in December 1988 is to provide further insight into the long-term safety, efficacy and compliance of terazosin, a long-acting selective alpha 1-blocker, for the treatment of symptomatic benign prostatic hyperplasia (BPH). A total of 45 normotensive patients with symptomatic BPH was enrolled into this study. The dose of terazosin was titrated to 5 mg. during a 1-month period provided adverse reactions and orthostatic hypotension were not observed. The subjects were maintained on 5 mg. terazosin throughout the 24-month followup. The peak and mean urinary flow rates, obstructive and irritative Boyarsky symptom scores, and systolic and diastolic blood pressures were evaluated at 2, 6, 12, 18 and 24 months after initiation of therapy. Of the 45 subjects 21 (47%) exhibited a durable clinical response with no significant adverse events during the 24-month followup. The obstructive and irritative symptom scores decreased by 63% and 35%, respectively, after 2 months of terazosin therapy. These improvements in obstructive and irritative symptom scores were maintained throughout the 2-year followup. The peak and mean urinary flow rates improved by 42% and 48%, respectively, after 2 months of terazosin therapy. The changes in mean urinary flow rate increased, whereas the changes in peak urinary flow rate decreased during followup. Of the patients 6 (13%) were withdrawn from the study due to an adverse event. Our study demonstrates the safety, efficacy and compliance of terazosin therapy for BPH during a 2-year followup.