TY - JOUR
T1 - Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder
AU - Corcos, Jacques
AU - Angulo, Javier C.
AU - Garely, Alan D.
AU - Carlsson, Martin
AU - Gong, Jason
AU - Guan, Zhonghong
N1 - Funding Information:
Funding for this study was provided by Pfizer Inc.
PY - 2011/5
Y1 - 2011/5
N2 - Objective: To assess the onset of efficacy of fesoterodine 4 mg versus placebo in subjects with overactive bladder (OAB) symptoms Research design and methods: Subjects who reported OAB symptoms for ≥3 months and recorded ≥8 micturitions and ≥1 urgency urinary incontinence (UUI) episode per 24 hours in 3-day baseline diaries were randomized to fesoterodine 4 mg, tolterodine extended release (ER) 4 mg, or placebo. This is an analysis of first week data from a 12-week, double-blind trial. ClinicalTrials.gov unique ID: NCT00444925 Main outcome measures: Baseline to week 1 changes in 3-day bladder diary variables, Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) scores reported by subjects receiving fesoterodine 4 mg or placebo. Results: By week 1, fesoterodine 4 mg (n = 679) was associated with significantly greater improvements compared with placebo (n = 334) in micturitions, urgency, severe urgency and UUI episodes, frequency-urgency sum, and MVV per 24 hours and 3-day diary-dry rate (all p<0.05), but not nocturnal micturitions per 24 hours (p=0.273). These differences were significant as early as day 5 of treatment (i.e., day 1 of the 3-day diary) for all diary endpoints except nocturnal micturitions and MVV. Changes in PPBC scores were significantly more favorable with fesoterodine 4 mg versus placebo (p=0.0143); changes in UPS scores were not significantly different (p=0.077). Conclusion: The results provide evidence that patients receiving fesoterodine 4 mg for their OAB symptoms may expect to experience a response as early as 1 week after initiating treatment. One limitation is that, although 65% of subjects had received treatment with antimuscarinics before the study, whether subjects were dissatisfied with previous treatment and reasons for dissatisfaction were not collected. This might affect the magnitude of outcome improvements. Also, it is not known whether the UPS is sensitive enough to detect treatment differences as early as week 1.
AB - Objective: To assess the onset of efficacy of fesoterodine 4 mg versus placebo in subjects with overactive bladder (OAB) symptoms Research design and methods: Subjects who reported OAB symptoms for ≥3 months and recorded ≥8 micturitions and ≥1 urgency urinary incontinence (UUI) episode per 24 hours in 3-day baseline diaries were randomized to fesoterodine 4 mg, tolterodine extended release (ER) 4 mg, or placebo. This is an analysis of first week data from a 12-week, double-blind trial. ClinicalTrials.gov unique ID: NCT00444925 Main outcome measures: Baseline to week 1 changes in 3-day bladder diary variables, Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) scores reported by subjects receiving fesoterodine 4 mg or placebo. Results: By week 1, fesoterodine 4 mg (n = 679) was associated with significantly greater improvements compared with placebo (n = 334) in micturitions, urgency, severe urgency and UUI episodes, frequency-urgency sum, and MVV per 24 hours and 3-day diary-dry rate (all p<0.05), but not nocturnal micturitions per 24 hours (p=0.273). These differences were significant as early as day 5 of treatment (i.e., day 1 of the 3-day diary) for all diary endpoints except nocturnal micturitions and MVV. Changes in PPBC scores were significantly more favorable with fesoterodine 4 mg versus placebo (p=0.0143); changes in UPS scores were not significantly different (p=0.077). Conclusion: The results provide evidence that patients receiving fesoterodine 4 mg for their OAB symptoms may expect to experience a response as early as 1 week after initiating treatment. One limitation is that, although 65% of subjects had received treatment with antimuscarinics before the study, whether subjects were dissatisfied with previous treatment and reasons for dissatisfaction were not collected. This might affect the magnitude of outcome improvements. Also, it is not known whether the UPS is sensitive enough to detect treatment differences as early as week 1.
KW - Comparative effectiveness research
KW - Fesoterodine
KW - Muscarinic antagonist
KW - Tolterodine
KW - Treatment outcome
UR - http://www.scopus.com/inward/record.url?scp=79954549309&partnerID=8YFLogxK
U2 - 10.1185/03007995.2011.565044
DO - 10.1185/03007995.2011.565044
M3 - Article
C2 - 21428726
AN - SCOPUS:79954549309
SN - 0300-7995
VL - 27
SP - 1059
EP - 1065
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 5
ER -