Doxazosin for benign prostatic hyperplasia: an open-label, baseline-controlled study in Korean general practice.

BACKGROUND

Few studies have reported the treatment of benign prostatic hyperplasia (BPH) in Asian patients. We assessed the safety and efficacy of doxazosin, a selective alpha1-adrenoceptor antagonist, in the treatment of Korean patients with symptomatic BPH.

METHODS

Two hundred and ninety-five men, aged 48 years or older with clinical BPH, were enrolled in a 12-week, open-label, baseline-controlled, dose-titration, multicenter study. A 2-week, single-blind, placebo run-in was followed by 10 weeks of doxazosin treatment, initially administered at 1 mg/day, with upward titrations (2, 4, or 8 mg/day) at 2-week intervals. The international prostate symptom score (IPSS) was used to assess efficacy after 4, 6, and 10 weeks of active treatment.

RESULTS

The intent-to-treat (ITT) population comprised 249 patients (mean age 63.6 years). Doxazosin significantly reduced the mean total IPSS by 48%; similarly, the obstructive and irritative subscores were reduced from baseline by 51% and 39%, respectively (P < 0.001 for all scores: Wilcoxon rank sum test). In a subset analysis of 170 normotensive and 78 hypertensive patients, significant reductions in mean systolic and diastolic blood pressures relative to baseline were observed only in the hypertensive subset (P < 0.01). Similar results in mean IPSS were observed in older (> or =65 years, n = 100) and younger (45-64 years, n = 140) patients, as well as between normotensive and hypertensive patients. Thirty-nine patients reported adverse events: The most frequent were dizziness, dyspepsia, asthenia, somnolence, and dry mouth.

CONCLUSIONS

The efficacy and safety of doxazosin treatment for BPH were confirmed in this Asian population. Significant improvements in total IPSS, as well as obstructive and irritative subscores, were observed.