Efficacy of Low-Dose Tamsulosin in Chinese Patients with Symptomatic Benign Prostatic Hyperplasia
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Objective: To determine the efficacy and tolerability of low-dose tamsulosin 0.2 mg/day in Chinese patients with symptomatic benign prostatic hyperplasia (BPH).
Methods: 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 (Qmax) and average urinary flow rate (Qave) were the efficacy parameters. Adverse events and variations in blood pressure and heart rate were also monitored.
Results: 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 Qmax and Qave 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 Qmax 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.
Conclusions: 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.
KeywordsBenign Prostatic Hyperplasia Finasteride International Prostate Symptom Score Tamsulosin Terazosin
This study was supported by Yamanouchi Pharmaceutical Co., Ltd. The authors have provided no information on conflicts of interest directly relevant to the content of this study.
Participating investigators: Peking University First Hospital: Kan Gong, Zhisong He, Ningchen Li, Yanqun Na, Jianfeng Yuan, Gang Wang; Peking University People’s Hospital: Xiaobo Huang; Peking University Third Hospital: Zhongxin Chen; Beijing Jishuitan Hospital: Liu Liu; Beijing Chao Yang Hospital: Xiao Chen, Tongwen Ou, Yong Wang, Jianjn Xu, Junhui Zhang; Beijing Friendship Hospital: Lindong Du, Yuwen Guo, Qiang Shao; Beijing Ton Ren Hospital: Shan Chen, Yuexin Liu, Guangyin Zhang; Beijing Tian Tan Hospital: Yong Su; Beijing Xuan Wu Hospital: Zin Cui, Wei Gao, Xinzhou He, Jin Li, Yucheng Sun, Jain Wang, Yi Zhang; Beijing An Zhen Hospital: Zhu Hou, Qing Li, Yunhua Lin, Junsheng Wang, Xuemin Xu, Jian Xue, Hongyu Zhuang; Peking Union Medical College Hospital: Quanzong Mao, Shi Rong; Post and Telecommunication’s Hospital of Beijing: Su Yan; China-Japan Friendship Hospital: Jianxing Wang, Zhao Zhang; Beijing Hospital: Jingping Deng, Shumin Deng, Ming Liu, Hongxue Su, Ben Wan, Jianye Wang, Dong Wei, Jin Xu, Liqing Zhang, Yaoguang Zhang, Chenyang Zhong; General Hospital of PLA: Jinshan Lu; Navy General Hospital of PLA: Weimin Guan; General Hospital of Air Force: Xianchu Li, Bin Sun; No. 304 Hospital of PLA: Han Ma, Hualiang Yu; No. 309 Hospital of PLA: Chunbai Mo; General Hospital of Beijing Military Region: Fengling Sun, Xuehui Yang; General Hospital of Chinese People’s Armed Police Forces: Bing Gao, Xiangfu Zeng; The Second Artillery General Hospital of PLA: Dezhong Liu, Xiaoyi Zhang, Ziliang Zhang, Lian Zou; Beijing Chuiyangliu Hospital: Xianen Gu, Zhian Yan; Beijing Municipal No. 6 Hospital: Lin Chen, Lian Liu; Beijing Hepingli Hospital: Jian Liu, Huizhi Zu; Beijing Fu Xing Hospital: Tiezhu Ge, Yuan Qu, Qian Zhang, Weiri Zhang; General Hospital Under the Beijing Railway Administration: Yan Bai, Haitao Wang, Hang Yin, Weiji Zhang; No. 402 Hospital, Ministry of Electronics Industry: Haichang Li, Zeng Yan; Beijing Jiuxianqiao Hospital, Ministry of Electronics Industry: Yuelin Gao, Qiang Li, Jinghua Shen, Qishan Sun, Shiqi Yan, Weidong Zhang; General Hospital of Coal Industry Ministry of China: Wei Zhong.
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