Efficacy and safety of long-term administration of tamsulosin hydrochloride in patients with LUTS suggestive of BPH / 中华泌尿外科杂志

ABSTRACT

Objective To evaluate the efficacy and safety of long-term administration of tamsulosin hydrochloride 0.2 mg once daily in patients with LUTS of BPH. Methods Patients with LUTS of BPH enrolled in a 4-week placebo run-in period, then 60-week open-label study. Tamsulosin hydrochloride 0.2 mg was administered before breakfast every day during the period of the study. The efficacy and safety parameters were evaluated at the end of treatment period Ⅰ (0-12 weeks). If IPSS was improved by 25% or more, the administration of tamsulosin hydrochloride was continued during treatment period Ⅱ (13-60 weeks). If the improvement rate less than 25%, the patients received concomitant medication of finasteride 5 mg once daily during treatment period Ⅱ. The primary parameters assessed to determine efficacy were the International Prostate Symptom Score(IPSS) and maximum urinary flow rate(Qmax). Results A total of 113 patients were recruited in the study, and 111 patients completed treatment period Ⅰ , and 95 patients completed treatment period Ⅱ. After treatment period Ⅰ , average IPSS was decreased by 4.1 and average Qmax was increased by 1.7 ml/s(P＜0.05). Tamsulosin hydrochloride produced a great improvement in average Qmax (3.0 ml/s, 27.7%)and a significant decrease in average IPSS (6.4,30.3%) after 60-week treatment. Significant improvements were also produced in average urinary flow rate and average residual urine volume. There was no significant difference in changes in IIEF-5 score and the prostate volume after treatment with tamsulosin hydrochloride. During the study period, 13 patients experienced 24 adverse events, and the incidence of adverse event was 11.5%. No serious adverse event and significant changes of the data of laboratory examination were recorded during the study. Conclusions Long-term tamsulosin hydrochloride therapy is a safe, effective and well-tolerated method in improving symptoms and quality of life in patients with LUTS of BPH. Tamsulosin hydrochloride can be used as the conventional drug in the patients with LUTS suggestive of BPH.