Doxazosin in the Symptomatic Treatment of Benign Prostatic Hyperplasia / 대한비뇨기과학회지

ABSTRACT

PURPOSE: This study set out to investigate the safety and efficacy of doxazosin treatment in symptomatic patients with benign prostatic hyperplasia(BPH) in Korea. MATERIALS AND METHODS: 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 1mg per day which, at 2-week intervals, could have been titrated up to 2, 4, or 8mg per day. Efficacy, in terms of International Prostate Symptom Score(I-PSS) and blood pressure(BP), was assessed from Week 6 onwards. RESULTS: 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completed the study, with the most common reason for withdrawal being lost to follow-up(35 cases); four patients were withdrawn due to adverse events.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- or hypertensive patients showed that in the 26 hypertensive patients mean systolic BP was reduced by 12.3%(-19mmHg) and mean diastolic BP by 13.7%(-14mmHg), whereas in normotensive patients the reductions were 4.0%(-5mmHg) and 1.9%(-1.5mmHg), 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(> or =65 years; n=91 ) compared with younger patients(7.5/5.8mmHg compared with 6.5/5.0mmHg). There were no differences in I-PSS improvement. Twenty eight adverse events were reported by 16 patients, the most commomly reported events being dizziness, postural hypotension, and headache. CONCLUSIONS: The effectiveness and safety of doxazosin in the treatment of BPH was confirmed in this Korean 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.