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67th Annual Meeting Abstracts


Solifenacin Significantly Improves Symptom Bother In Patients With Overactive Bladder
*Michael Vardy1, *H David Mitcheson2, *Terri−Ann Samuels1, *Tom Marshall3, *Sergio Forero-Schwanhaeuser4, *Weizhong He5
1Mt. Sinai School of Medicine, New York, NY;2Bay State Clinical Trials, Inc., Watertown, MA;3Astellas Pharma US, Inc., Deerfield, IL;4GlaxoSmithKline, King of Prussia, PA;5Astellas Pharma Global Development, Inc., Deerfield, IL

Introduction: To assess the efficacy of solifenacin on symptom bother, health-related quality of life (HRQL), and overactive bladder (OAB) symptoms in patients with OAB using the Overactive Bladder Questionnaire (OAB-q) and bladder diaries.
Materials & Methods: Patients with OAB for ≥3 months were randomized to flexibly dosed (5 or 10 mg) solifenacin or placebo for 12 weeks. At baseline and at 4-week intervals, patients completed the OAB-q (Symptom Bother and HRQL) and 3-day bladder diaries. The primary efficacy variable was mean change from baseline to Week 12 in Symptom Bother score. Secondary variables included changes in HRQL and OAB symptoms.
Results: At Weeks 4, 8, and 12, solifenacin significantly reduced mean Symptom Bother score versus placebo as well as all HRQL domains and all OAB symptoms except nocturia versus placebo. Expected treatment-related adverse events in solifenacin versus placebo patients included dry mouth (13% versus 2%), constipation (8% versus 2%), dry eye (2% vs <1%), and blurred vision (1% versus 1%).
Table 1. Summary of results for OAB-q and bladder diary variables
Mean at
Baseline
Mean Change From Baseline to W12
OAB-q scale

Domain
Placebo
(n=374)
Solifenacin
(n=377)
Placebo
(n=374)
Solifenacin
(n=377)
P-Value
Symptom Bother*57.958.2-20.4-29.9<0.0001
Total HRQL (all 4 domains)57.856.416.725.3<0.0001
Coping53.752.218.628.5<0.0001
Concern52.051.919.329.2<0.0001
Sleep51.347.317.426.6<0.0001
Social Interaction78.978.79.313.6<0.0001
Bladder diary variable
Urgency*5.75.7-1.84-3.05<0.0001
Frequency*11.911.7-1.36-2.23<0.0001
Incontinence*2.82.9-1.24-1.850.0024
Nocturia*1.61.7-0.48-0.630.3408
*A negative value indicates improvement.
Based on ANCOVA model including terms for treatment, pooled center, and baseline value.

Conclusions: As early as Week 4 and through Week 12, flexibly dosed solifenacin significantly improved symptom bother and HRQL, as well as urgency, frequency, and incontinence compared with placebo. Solifenacin was well tolerated.


 

 

 
     
     
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