One Year Long-term Evaluation of Tamsulosin HCl(0.2 mg) in Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Obstruction: Analysis of a Korean, Multicenter, Single-Blind Study

ABSTRACT

PURPOSE: To evaluate the long-term efficacy and safety of tamsulosin 0.2 mg once daily in Korean patients with lower urinary tract symptoms(LUTS) suggestive of benign prostatic obstruction(BPO) treated for up to 1 year. MATERIALS AND METHODS: Two hundred eleven patients were enrolled from 6 centers and 146 patients were included in the analysis. The primary efficacy parameters were improvements in the total, obstructive and irritative International Prostate Symptom Score(IPSS) and maximal urinary flow rate(Qmax). The secondary efficacy parameters were a decrease of >or=30% in IPSS and an increase of >or=30% in Qmax from baseline. Changes in parameters between baseline and 52 weeks were assessed using Student's paired t-test. RESULTS: Statistically significant, gradual improvements in all efficacy parameters were observed over the 1-year period. Tamsulosin 0.2 mg/day produced progressive improvements in total IPSS(41.1%) and Qmax(39.6%, 4.56 ml/sec)(p<0.001). Tamsulosin was well tolerated. The incidence of adverse events was only 6.2%. And There were no withdrawals as a result of adverse events. There were no significant changes in blood pressure or pulse rate during the study. CONCLUSION: Long-term 1-year treatment with tamsulosin 0.2 mg once daily in Korean BPO patients is safe, well tolerated and effective in improving LUTS and urinary flow. The effect on symptoms was apparent after 12 weeks of treatment, and symptom improvement was achieved for up to 1 year at every follow-up period respectively.