| Long-term safety, tolerability and efficacy of fesoterodine in subjects with overactive bladder symptoms stratified by age: pooled analysis of two open-label extension studies. | |
| | |
MedLine Citation:
|
PMID: 22276958 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
|
Background: Previous work has demonstrated the efficacy and safety of fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term fesoterodine treatment in different age groups has not been assessed. Objective: The aim was to determine the impact of age on the safety, tolerability and efficacy of long-term treatment with fesoterodine 8 mg in subjects with OAB syndrome. Methods: This was a pooled analysis of two identically designed open-label extensions of 12-week, randomized, double-blind, placebo-controlled studies. The setting was urology and general practice offices. Subjects who participated in the 12-week, double-blind studies and opted to continue long-term, open-label treatment with fesoterodine were included. Subjects were initiated on fesoterodine 8 mg/day at open-label baseline. After 1 month, subjects could elect dose reduction to 4 mg/day and subsequent re-escalation to 8 mg; each was permitted once annually. Maximal duration of open-label treatment ranged from 24 to 36 months. Discontinuations, subject-reported treatment tolerance, and efficacy (3-day diaries) were assessed at open-label baseline and months 1, 4, 8, 12 and 24. Results: A total of 890 subjects were treated (age <45 years, n = 140; 45-64 years, n = 444; 65-74 years, n = 208; ≥75 years, n = 98); 49% continued treatment for ≥24 months (age <45 years, 43%; 45-64 years, 54%; 65-74 years, 50%; ≥75 years, 37%). Seventy-seven percent of subjects remained on fesoterodine 8 mg throughout treatment; this rate was highest among subjects aged ≥75 years (age <45 years, 72%; 45-64 years, 77%; 65-74 years, 73%; ≥75 years, 87%). Approximately 80% of continuing subjects were receiving fesoterodine 8 mg at each visit after open-label baseline up to 36 months. No new or unexpected safety signals were observed in any age group. Most subjects reported 'good' or 'excellent' treatment tolerance throughout the study (age <45 years, ≥90%; 45-64 years, ≥93%; 65-74 years, ≥85%; ≥75 years, ≥86%). Dry mouth, the most commonly reported treatment-emergent adverse event, was lowest among subjects aged ≥75 years (age <45 years, 31%; 45-64 years, 30%; 65-74 years, 32%; ≥75 years, 26%). Rates of discontinuation due to dry mouth were low in all age groups. Significant improvements in all diary variables, including urgency urinary incontinence episodes per 24 hours, micturitions per 24 hours, urgency episodes per 24 hours, and mean voided volume per micturition, observed between double-blind baseline and open-label baseline were sustained or increased during open-label treatment in the overall population and all age groups. Conclusions: Long-term fesoterodine (administered primarily as 8 mg) was well tolerated and associated with sustained improvements in OAB symptoms, irrespective of age. |
| | |
Authors:
|
Peter K Sand; John Heesakkers; Stephen R Kraus; Martin Carlsson; Zhonghong Guan; Sandra Berriman |
Related Documents
:
|
21508958 - Enterotypes of the human gut microbiome. 21424788 - Interaction between age of irradiation and age of testing in the disruption of operant ... 21316878 - Very preterm children free of disability or delay at age 2: predictors of schooling at ... 21222288 - Strategy selection and aging: impact of item concreteness in paired-associate task. 10087628 - Wing-size heritability in a natural population of drosophila subobscura. 9232978 - Injuries in australian army recruits. part iii: the accuracy of a pretraining orthopedi... |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: Drugs & aging Volume: 29 ISSN: 1170-229X ISO Abbreviation: Drugs Aging Publication Date: 2012 Feb |
Date Detail:
|
Created Date: 2012-01-26 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 9102074 Medline TA: Drugs Aging Country: New Zealand |
Other Details:
|
Languages: eng Pagination: 119-31 Citation Subset: IM |
Affiliation:
|
NorthShore University HealthSystem, University of Chicago, Pritzker School of Medicine, Chicago, IL, USA. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Er:YAG laser treatment in supportive periodontal therapy.
Next Document: Associations between Drug Burden Index and Mortality in Older People in Residential Aged Care Facili...