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| | | ![]() Silodosin Provides Rapid, Effective Relief of Urinary Symptoms in Men With Benign Prostatic Hyperplasia: Presented at AUA By Bruce Sylvester CHICAGO -- April 30, 2009 -- Silodosin produces fast and significant improvements in urinary symptoms associated with benign prostatic hyperplasia (BPH), according to an analysis of pooled data from 2 clinical trials presented here at the 2009 American Urological Association (AUA) Annual Meeting. "In these phase 3 trials, silodosin provided rapid and effective relief of all irritative and obstructive symptoms," said presenter and lead investigator Leonard Marks, MD, University California Los Angeles School of Medicine, Los Angeles, California, on April 29. The study was a post hoc analysis of pooled data from 2 identically designed, randomised, placebo-controlled, double-blind trials in which a total of 923 men, aged 50 years and older, with signs and symptoms of BPH were randomised to either silodosin 8 mg/day (n = 466) or a placebo (n = 457) for 12 weeks. The men had a peak urine flow rate (Qmax) of between 4 and 15 mL/second, with a mean rate of 8.7 to 8.9, and an International Prostate Symptom Score (IPSS) >=13 (mean, 21.3). For the post hoc analysis, the investigators assessed changes in IPSS subscales measuring irritative symptoms (frequency, urgency, and nocturia) and obstructive symptoms of BPH (incomplete emptying, intermittency, weak stream, and straining). They reported that, from baseline, men treated with silodosin achieved statistically significant changes in all IPSS subscales, with the exception of nocturia. Notably, the improvements in symptoms, except for nocturia, were rapidly and statistically significantly better for silodosin-treated patients than for placebo subjects, within 3 to 4 days of first treatment (P < .001). These significant differences lasted throughout 12 weeks of treatment. (P < .0001; P = .0037 for nocturia). Funding for this study was provided by Watson Pharmaceuticals.
[Presentation title: Rapid Response of Irritative and Obstructive Urinary Symptoms of Benign Prostatic Hyperplasia to Treatment With Silodosin in 2 Randomized Studies. Abstract 1921]
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