DOXAZOSIN IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA IN NORMOTENSIVE PATIENTS - A MULTICENTER STUDY

A 16-week, double-blind, placebo controlled, dose titration study was done on 100 normotensive patients age 45 years or older to determine t he efficacy and safety of doxazosin, a selective alpha 1-adrenoceptor antagonist, in the treatment of benign prostatic hyperplasia (BPH). Of the 41 efficacy evaluable patients 88% underwent dose titration to a maximum of 8 mg. doxazosin once daily. Maximum and average urinary flo w rates increased significantly above baseline with doxazosin (2.9 ml. per second and 1.4 ml. per second, respectively) compared with placeb o (0.7 ml. per second and 0.3 ml. per second, respectively). A signifi cant effect on maximum flow rate was noted as early as week 2 of doubl e-blind treatment at the initial efficacy evaluation. Doxazosin was su perior to placebo in patient and investigator assessments of total, ob structive and irritative BPH symptoms. The onset of efficacy for total patient-assessed symptoms was significant for doxazosin compared to p lacebo 4 weeks after the start of the treatment regimen. Statistically significant decreases in mean blood pressure of 4 to 6 mm. Hg were no ted with doxazosin compared with placebo. Adverse events, primarily mi ld to moderate in severity, were reported in 44% of patients given dox azosin and 30% of those given placebo. Our results strongly demonstrat e that doxazosin is significantly superior to placebo in the treatment of BPH in normotensive patients, with the patient experiencing signif icant relief early after initiation of therapy.