PURPOSE: We evaluated the long-term (up to 6 years) safety and efficacy of the selective alpha 1A-adrenoceptor antagonist tamsulosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 609 patients were enrolled in a 4-year multicenter open label extension study. Subjects entered the study after completion of a 1-year open label trial that included patients who previously completed up to 57 weeks of double-blind, placebo controlled studies. Maintenance doses (0.4 or 2 x 0.4 mg daily) established in the 1-year study were continued. Efficacy and safety were assessed every 3 months. Primary efficacy evaluations were changes from baseline maximum urine flow rate and total American Urological Association symptom index, and the responder rates for those 2 end points. Secondary end points were changes in American Urological Association subset scores, Boyarsky symptom scores, average urine flow rate, post-void residual urine volume, quality of life index and investigator global assessment. RESULTS: Of the 609 patients who entered the 4-year extension study 159 had a 2-year or greater prior experience with tamsulosin, yielding a potential 6-year experience on the medication. Of this 159 patient subset 109 completed the whole 6 years. Initial rapid improvements from baseline in primary and secondary end points were maintained each year throughout the duration of the study. Tamsulosin was well tolerated, confirming the safety profile demonstrated in earlier studies. Orthostatic hypotension was observed in 1.3% of the patients. CONCLUSIONS: This study demonstrates the sustained efficacy, safety and excellent long-term tolerability of tamsulosin for up to 6 years in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.
RCT Entities:
PURPOSE: We evaluated the long-term (up to 6 years) safety and efficacy of the selective alpha 1A-adrenoceptor antagonist tamsulosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 609 patients were enrolled in a 4-year multicenter open label extension study. Subjects entered the study after completion of a 1-year open label trial that included patients who previously completed up to 57 weeks of double-blind, placebo controlled studies. Maintenance doses (0.4 or 2 x 0.4 mg daily) established in the 1-year study were continued. Efficacy and safety were assessed every 3 months. Primary efficacy evaluations were changes from baseline maximum urine flow rate and total American Urological Association symptom index, and the responder rates for those 2 end points. Secondary end points were changes in American Urological Association subset scores, Boyarsky symptom scores, average urine flow rate, post-void residual urine volume, quality of life index and investigator global assessment. RESULTS: Of the 609 patients who entered the 4-year extension study 159 had a 2-year or greater prior experience with tamsulosin, yielding a potential 6-year experience on the medication. Of this 159 patient subset 109 completed the whole 6 years. Initial rapid improvements from baseline in primary and secondary end points were maintained each year throughout the duration of the study. Tamsulosin was well tolerated, confirming the safety profile demonstrated in earlier studies. Orthostatic hypotension was observed in 1.3% of the patients. CONCLUSIONS: This study demonstrates the sustained efficacy, safety and excellent long-term tolerability of tamsulosin for up to 6 years in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.