Safety assessment of terazosin in the treatment of patients with symptomatic benign prostatic hyperplasia: a combined analysis.

This study reviews and assesses the safety of terazosin for the treatment of symptomatic benign prostatic hyperplasia (BPH). Six placebo-controlled trials (including two unpublished series) involving 996 patients provide the database for this evaluation. Six hundred thirty-six patients received terazosin from 1 to 20 mg daily for a total of 229 patient-years of exposure to terazosin. The most common final dose of terazosin was 10 mg once daily. Side effects were generally mild or moderate in severity and resolved following cessation of therapy. Side effects resulted in premature withdrawal in 9% of terazosin-treated patients and 7% of placebo-treated patients (difference not significant). Dizziness (2.0%) and headache (1.1%) were the most common symptoms leading to premature withdrawal from the studies. Although postural symptoms and dizziness were slightly more common in those terazosin-treated patients 65 or more years old compared with patients less than 65 years old, this difference was not statistically significant. Only 4 of the 636 patients (0.6%) had syncopal episodes; 2 of these occurred at initiation of terazosin therapy or at dose escalation. Minimal reductions in blood pressure were observed in normotensive patients and patients with hypertension controlled by concomitant medication, whereas patients with untreated hypertension had substantial decreases in both systolic and diastolic blood pressures. Statistically significant increases in high density lipoprotein to cholesterol ratio and reductions in total cholesterol, low density lipoprotein, and triglycerides were also seen. This combined analysis suggests that terazosin can be safely administered to both normotensive and hypertensive patients with symptomatic BPH.