Abstract
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 α1-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 (≥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.
| Original language | English |
|---|---|
| Pages (from-to) | 159-165 |
| Number of pages | 7 |
| Journal | International Journal of Urology |
| Volume | 12 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 2005 Feb 1 |
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All Science Journal Classification (ASJC) codes
- Urology
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Doxazosin for benign prostatic hyperplasia : An open-label, baseline-controlled study in Korean general practice. / Chung, Byung Ha; Hong, Sung Joon; Lee, Moo Sang.
In: International Journal of Urology, Vol. 12, No. 2, 01.02.2005, p. 159-165.Research output: Contribution to journal › Article
TY - JOUR
T1 - Doxazosin for benign prostatic hyperplasia
T2 - An open-label, baseline-controlled study in Korean general practice
AU - Chung, Byung Ha
AU - Hong, Sung Joon
AU - Lee, Moo Sang
PY - 2005/2/1
Y1 - 2005/2/1
N2 - 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 α1-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 (≥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.
AB - 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 α1-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 (≥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.
UR - http://www.scopus.com/inward/record.url?scp=16244389702&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=16244389702&partnerID=8YFLogxK
U2 - 10.1111/j.1442-2042.2005.00998.x
DO - 10.1111/j.1442-2042.2005.00998.x
M3 - Article
C2 - 15733110
AN - SCOPUS:16244389702
VL - 12
SP - 159
EP - 165
JO - International Journal of Urology
JF - International Journal of Urology
SN - 0919-8172
IS - 2
ER -