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Long-term safety, tolerability, and efficacy of fesoterodine treatment in men and women with overactive bladder symptoms.
MedLine Citation:
PMID:  21355814     Owner:  NLM     Status:  Publisher    
Abstract Objective: To evaluate long-term safety, tolerability, and efficacy of fesoterodine for men and women with overactive bladder (OAB) symptoms. Research design and methods: This was a post hoc analysis of data pooled from two open-label extensions (NCT00220402, NCT00220376) of double-blind studies. All subjects began open-label treatment with fesoterodine 8?mg once daily, with voluntary dose reduction to 4?mg and re-escalation to 8?mg each permitted once annually. Maximum allowable duration of open-label treatment ranged from 24 to 36 months. Main outcome measures: Safety and discontinuations were assessed throughout treatment; subject-reported treatment tolerability and 3-day bladder diaries were evaluated at open-label baseline and months 1, 4, 8, 12, and 24. Results: A total of 185 men and 705 women enrolled; 83 men (45%) and 356 women (50%) continued open-label treatment for ?24 months. Most men (84%) and women (75%) remained on fesoterodine 8?mg throughout open-label treatment. No new or unexpected safety signals were observed. Dry mouth was the most common treatment-emergent adverse event (men, 24%; women, 32%), rates of discontinuation due to dry mouth were low (men, 1%; women, 2%). Most men and women (?91%) reported at least ?good? tolerance. For men and women, statistically significant improvements in urgency urinary incontinence episodes, micturitions, urgency episodes, and mean voided volume per micturition achieved between double-blind baseline and open-label baseline were sustained or further improved through month 24; significant improvements in most OAB symptoms were observed between double-blind baseline and month 24 when subjects were stratified by double-blind treatment (placebo, tolterodine extended release 4?mg, fesoterodine 4?mg, fesoterodine 8?mg). Limitations include the lack of a placebo control and that subjects completing double-blind treatment may have been more likely to tolerate or respond to long-term fesoterodine treatment. Conclusions: Long-term fesoterodine treatment was well tolerated and associated with sustained improvements in OAB symptoms in men and women.
Harriette Scarpero; Peter K Sand; Con J Kelleher; Sandra Berriman; Tamara Bavendam; Martin Carlsson
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-3-1
Journal Detail:
Title:  Current medical research and opinion     Volume:  -     ISSN:  1473-4877     ISO Abbreviation:  -     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-3-1     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Associated Urologists, Nashville, TN, USA.
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