Doxazosin in the treatment of benign prostatic hyperplasia (bph): an open, baseline-controlled study in korean general urology practice

There are very few studies reporting the treatment of BPH in the developing countries of Asia. This study set out to investigate the safety and efficacy of doxazosin treatment in symptomatic patients with BPH in Korea. A total of 237 male patients aged 50 or over with clinical evidence of BPH were enrolled into this 12-week, open, baseline-controlled, dose-response study. A run-in period of 2 weeks placebo treatment was followed by 10 weeks of doxazosin treatment. The initial dose was 1 mg per day which, at 2-week intervals, could have been titrated to 2, 4, or 8 mg per day. Efficacy, in terms of International Prostate Symptom Score (I-PSS) and blood pressure (BP), was assessed from Week 6 onwards. A total of 180 patients (mean age 65.3 years) completed the study, with the most common reason for withdrawal being lost to follow-up (35 patients); four patients were withdrawn due to adverse events. Mean I-PSS score was reduced by 48.8% (from 21.5 at baseline to 11 at completion). Subset analysis of normo- and hypertensive patients showed that in the 26 hypertensive patients mean systolic BP was reduced by 12.3% (-19 mm Hg) and mean diastolic BP by 13.7% (-14 mm Hg ), whereas in normotensive patients the reductions were 4.0% (-5 mm Hg) and 1.9% (-1.5 mm Hg), respectively. No differences in I-PSS improvements were seen between these two groups. The effects of age were also investigated and showed no significant differences in the changes in blood pressure for older patients (>65 years; n=91 ) compared with younger patients (7.5/5.8 mm Hg compared with 6.5/5.0 mm Hg). There were no differences in I-PSS improvement. Twenty-eight adverse events were reported by 16 patients, with the most commonly reported events being dizziness, postural hypotension, and headache. The effectiveness and safety of doxazosin in the treatment of BPH was confirmed in this Asian population, with significant improvements in I-PSS regardless of patient age and blood pressure at baseline. The baseline I-PSS was higher than is commonly seen in European populations, indicating a greater disease severity.