BACKGROUND:Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia (BPH) symptoms after the first dose and achieve long-term efficacy in European and American populations; however, the corresponding studies from China are rarely seen. The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms (LUTS) suggestive of BPH in China. METHODS:Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study. Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study. The efficacy and safety parameters were evaluated at the end of treatment period I (0 - 12 weeks) and period II (13 - 60 weeks). The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. RESULTS:A total of 113 patients were recruited to the study. Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period II. Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate (Q(max)) (1.7 ml/s, 3 ml/s) and a significant decrease in mean international prostate symptom score (IPSS) (4.1, 6.4) after 12-week and 60-week treatments, respectively. At the end of treatment period II, there were significant improvement in IPSS, quality of life (QOL) score, Q(max) and average flow rate (Q(ave)) for combination therapy group compared with the treatment period I (all P < 0.05). No serious adverse events (SAE) were recorded during the study. CONCLUSION: Long-term tamsulosin hydrochloride therapy is a safe, effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China.
RCT Entities:
BACKGROUND:Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia (BPH) symptoms after the first dose and achieve long-term efficacy in European and American populations; however, the corresponding studies from China are rarely seen. The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms (LUTS) suggestive of BPH in China. METHODS: Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study. Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study. The efficacy and safety parameters were evaluated at the end of treatment period I (0 - 12 weeks) and period II (13 - 60 weeks). The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. RESULTS: A total of 113 patients were recruited to the study. Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period II. Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate (Q(max)) (1.7 ml/s, 3 ml/s) and a significant decrease in mean international prostate symptom score (IPSS) (4.1, 6.4) after 12-week and 60-week treatments, respectively. At the end of treatment period II, there were significant improvement in IPSS, quality of life (QOL) score, Q(max) and average flow rate (Q(ave)) for combination therapy group compared with the treatment period I (all P < 0.05). No serious adverse events (SAE) were recorded during the study. CONCLUSION: Long-term tamsulosin hydrochloride therapy is a safe, effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China.