Efficacy of low-dose tamsulosin in chinese patients with symptomatic benign prostatic hyperplasia

• Published in: Clinical drug investigation Vol. 23; no. 12; pp. 781 - 787
• Main Authors: Li, Ning-Chen, Chen, Shan, Yang, Xue-Hui, Du, Lin-Dong, Wang, Jian-Ye, Na, Yan-Qun
• Format: Journal Article
• Language: English
• Published: New Zealand Wolters Kluwer Health, Inc 01.01.2003
• ISSN: 1173-2563; 1179-1918
• DOI: 10.2165/00044011-200323120-00003

To determine the efficacy and tolerability of low-dose tamsulosin 0.2 mg/day in Chinese patients with symptomatic benign prostatic hyperplasia (BPH). A total of 505 patients were enrolled in a 6-week nonblind, multicentre study, and 499 patients were followed for the entire 6-week treatment period. After a 2-week washout period, patients with confirmed symptomatic BPH were treated with tamsulosin 0.2mg daily. International Prostate Symptom Score (I-PSS), quality-of-life (QOL) index, maximum urinary flow rate (Q(max)) and average urinary flow rate (Q(ave)) were the efficacy parameters. Adverse events and variations in blood pressure and heart rate were also monitored. Total I-PSS and QOL index scores were improved from baseline with an average score reduction of 7.50 and 1.40, respectively (p < 0.01). Mean Q(max) and Q(ave) were increased by an average of 4.33 mL/sec (p < 0.01) and 2.04 mL/sec, respectively (p < 0.01). A subgroup analysis showed that total I-PSS, QOL index and Q(max) were significantly improved irrespective of baseline I-PSS, age, duration of BPH, comorbid conditions, or the use of concomitant antihypertensive agents. A positive correlation was noted between improvement in total I-PSS and QOL index (r = 0.70). Relative to baseline, systolic and diastolic blood pressure decreased by a mean of 3.35mm Hg and 2.74mm Hg, respectively (p < 0.01). A total of 28 treatment-related adverse reactions were reported in 24 patients (4.75%), the majority of which were mild dizziness and headache. Low-dose tamsulosin 0.2 mg/day has a favourable efficacy and tolerability profile in Chinese patients with symptomatic BPH irrespective of the baseline characteristics of these patients. No serious, unexpected adverse effects were identified.