Abstract | PURPOSE: MATERIALS AND METHODS: Men 50 years or older with an International Prostate Symptom Score of 13 or greater and peak urinary flow rate of 4 to 15 ml per second received placebo or 8 mg silodosin daily with breakfast for 12 weeks. The primary end point was International Prostate Symptom Score change from baseline to last observation. Change in peak urinary flow rate was a secondary end point. Differences in treatment efficacy were assessed by ANCOVA. RESULTS: Of 923 patients (mean age 65 years) 466 received silodosin and 457 placebo. After 0.5 week (range 3 to 4 days) of treatment patients receiving silodosin vs placebo achieved significant improvement in total International Prostate Symptom Score (difference -1.9, p <0.0001) and irritative (-0.5, p = 0.0002) and obstructive (-1.4, p <0.0001) subscores. The mean +/- SD change from baseline in total International Prostate Symptom Score was -4.2 +/- 5.3 for silodosin vs -2.3 +/- 4.4 for placebo. Differences ( silodosin vs placebo) in International Prostate Symptom Score and subscores increased by week 12 (p <0.0001). Mean change from baseline in peak urinary flow rate (ml per second) 2 to 6 hours after initial dose was greater (p <0.0001) with silodosin (2.8 +/- 3.4) than placebo (1.5 +/- 3.8). Differences remained significant (p <0.001) through week 12. The most common treatment emergent adverse event was (mostly mild) retrograde ejaculation ( silodosin 28.1% of patients, placebo 0.9%). Few patients receiving silodosin (2.8%) discontinued because of retrograde ejaculation. Proportions of patients with treatment emergent orthostatic hypotension were similar for silodosin (2.6%) and placebo (1.5%). CONCLUSIONS:
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Authors | Leonard S Marks, Marc C Gittelman, Lawrence A Hill, Weining Volinn, Gary Hoel |
Journal | The Journal of urology
(J Urol)
Vol. 181
Issue 6
Pg. 2634-40
(Jun 2009)
ISSN: 1527-3792 [Electronic] United States |
PMID | 19371887
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adrenergic alpha-1 Receptor Antagonists
- Indoles
- silodosin
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Topics |
- Adrenergic alpha-1 Receptor Antagonists
- Adult
- Aged
- Aged, 80 and over
- Double-Blind Method
- Humans
- Indoles
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Prostatic Hyperplasia
(diagnosis, drug therapy)
- Time Factors
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