Abstract | UNLABELLED: OBJECTIVE: SUBJECTS AND METHODS: • This was a double-blind, 12-week, flexible-dose trial. • Men with persistent storage symptoms (≥ 8 micturitions and ≥ 3 urgency episodes per 24 h) after receiving an α-blocker for ≥ 6 weeks were randomized to add-on fesoterodine 4 mg or placebo, with optional dose escalation to 8 mg at week 4 and reduction back to 4 mg at week 8 (or matching placebo adjustments). • Subjects completed 3-day diaries, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) at baseline and weeks 4 and 12. RESULTS: • A total of 943 men were randomized and received at least one dose of study treatment ( fesoterodine, n= 471; placebo, n= 472). • Among these, 251 (53%) in the fesoterodine group and 300 (64%) in the placebo group requested dose escalation at week 4 and 35 (7%) and 15 (3%) requested dose reduction at week 8. Changes from baseline to week 12 in urgency episodes (primary endpoint) in the fesoterodine (-3.2) and placebo (-2.9) groups were not significantly different (P= 0.196), but improvements in micturitions (P= 0.009) and OAB-q symptom bother score (P= 0.007) were significantly greater with fesoterodine. • At week 4, significantly greater improvements in micturitions (P= 0.006), severe urgency episodes (P= 0.006), IPSS storage score (P= 0.022), OAB-q symptom bother score (P= 0.004), and OAB-q health-related quality of life (P= 0.041), but not urgency episodes (P= 0.062), were observed with add-on fesoterodine. • Dry mouth ( fesoterodine, 21%; placebo, 6%) and constipation ( fesoterodine, 6%; placebo, 2%) were the most common adverse events. Dysuria and urinary retention were reported by 3% and 2% of subjects, respectively, in the fesoterodine add-on group vs 1% and <1% of subjects, respectively in the placebo add-on group. One subject in each group had acute urinary retention requiring catheterization. CONCLUSIONS: • Flexible-dose fesoterodine was well tolerated as an add-on treatment in men with persistent storage symptoms. • Changes in urgency episodes at week 12 (primary endpoint) and many secondary endpoints were not significantly different between fesoterodine and placebo add-on treatment; however, improvements in frequency and symptom bother were significantly greater with fesoterodine. • These data suggest that there remains a limited understanding of the optimal evaluation and treatment of men with LUTS.
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Authors | Steven A Kaplan, Claus G Roehrborn, Jason Gong, Franklin Sun, Zhonghong Guan |
Journal | BJU international
(BJU Int)
Vol. 109
Issue 12
Pg. 1831-40
(Jun 2012)
ISSN: 1464-410X [Electronic] England |
PMID | 21966995
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL. |
Chemical References |
- Adrenergic alpha-Antagonists
- Benzhydryl Compounds
- Muscarinic Antagonists
- fesoterodine
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Topics |
- Adrenergic alpha-Antagonists
(administration & dosage)
- Adult
- Aged
- Aged, 80 and over
- Benzhydryl Compounds
(administration & dosage)
- Double-Blind Method
- Drug Therapy, Combination
- Humans
- Male
- Middle Aged
- Muscarinic Antagonists
(administration & dosage)
- Prostatic Hyperplasia
(complications)
- Treatment Outcome
- Urinary Bladder, Overactive
(drug therapy)
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