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Presented Data Confirm That RAPAFLO(TM) (silodosin) Provides Rapid, Highly Effective, Symptom Relief for Benign Prostatic Hyperplasia (BPH) Patients
Date:4/28/2009

reason patients visit urologists and is characterized by urination problems, including decreased urine flow, more frequent urination and nocturia.

AUA Data Results

The first abstract was a post-hoc analysis of two randomized, placebo-controlled, double-blind clinical trials involving 923 men ages 50 or older with signs and symptoms of BPH, including a peak urine flow rate (Qmax) between 4 and 15 mL/sec (mean of 8.7 to 8.9) and International Prostate Symptom Score (IPSS) greater than or equal to 13 (mean of 21.3). Patients were randomized to either 8 mg RAPAFLO(TM) once daily (n=466) or placebo (n=457) for 12 weeks. In this analysis, researchers assessed changes in IPSS subscales by evaluating seven questions related to irritative symptoms (frequency, urgency and nocturia) and obstructive symptoms (incomplete emptying, intermittency, weak stream and straining). Mean baseline scores for all seven measures were very similar between the two groups.

At the last observation, patients treated with RAPAFLO(TM) versus placebo experienced significantly greater changes in all IPSS subscales from baseline measures. The differences in all symptoms except nocturia were statistically significantly better for RAPAFLO(TM) versus placebo within three to four days (p<0.001). Improvements in nocturia were more significant with RAPAFLO(TM) versus placebo at week one (p=0.0091). Statistically significant differences were maintained throughout the remainder of the 12 weeks (p<0.0001; p=0.0037 for nocturia).

The second abstract -- another post-hoc analysis of the two RAPAFLO(TM) clinical trials -- examined whether retrograde ejaculation might be associated with treatment efficacy. Among the 466 men treated with RAPAFLO(TM) in the two trials, a total of 131 men (28.1 percent) experienced retrograde ejaculation. Overall, baseline IPSS and Qmax scores were comparable in
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SOURCE Watson Pharmaceuticals, Inc.
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