Long-term safety and efficacy of XXXX for the treatment of lower urinary tract symptoms associated with @entity1067 .

@entity1 @entity1067 @entity551 @entity13365 @entity9940
PURPOSE: We evaluated the long-term (up to 6 years) safety and efficacy of the selective @entity13365 antagonist @entity9940 in @entity1 with lower urinary tract symptoms associated with @entity1067 . MATERIALS AND METHODS: A total of 609 @entity1 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 @entity1 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 @entity1 who entered the 4-year extension study 159 had a 2-year or greater prior experience with @entity9940 , yielding a potential 6-year experience on the medication. Of this 159 @entity1 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. @entity9940 was well tolerated, confirming the safety profile demonstrated in earlier studies. @entity551 was observed in 1.3% of the @entity1 . CONCLUSIONS: This study demonstrates the sustained efficacy, safety and excellent long-term tolerability of @entity9940 for up to 6 years in @entity1 with lower urinary tract symptoms associated with @entity1067 .
