THE INTERNATIONAL TERAZOSIN TRIAL - A MULTICENTER STUDY OF THE LONG-TERM EFFICACY AND SAFETY OF TERAZOSIN IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA

Objective: To evaluate the long-term efficacy and safety of terazosin in the treatment of benign prostatic hyperplasia (BPH); Methods: Thirt y-three sites in 13 countries enrolled men with BPH who had an Interna tional Prostate Symptom Score (IPSS) less than or equal to 12. After a 2-week, no-treatment lead-in period and a 26-week, single-blind treat ment period, patients responding to terazosin were randomly assigned t o receive either terazosin or placebo for a 24-week, double-blind with drawal period. Results: Of the initial 427 patients enrolled, 378 were evaluable, 273 of whom completed the single-blind period, of which 18 6 patients were randomized. During the single-blind treatment period, IPSS, quality-of-life score (QOL), peak flow rate (PFR), and nocturia score (NOC) improved significantly(p less than or equal to 0.05). Duri ng the double-blind withdrawal period, IPSS, QOL, PFR, and NOC deterio rated significantly in the placebo group compared with the terazosin g roup. The most common adverse event resulting in premature termination from the study was dizziness. There were no clinically important mean reductions in diastolic blood pressure (DBP) for patients normotensiv e at baseline. Terazosin significantly reduced mean DBP in hypertensiv e patients during the single-blind period and maintained the reduction during the double-blind period. Conclusion: Treatment with terazosin has a beneficial effect on BPH, continuing for at least 12 months, and can be safely considered for medium- to long-term use in those who be nefit.