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Clinical Drug Investigation

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01-05-2009 | Original Research Article

Diary and Patient-Reported Outcomes in Patients with Severe Overactive Bladder Switching from Tolterodine Extended Release 4mg/day to Solifenacin Treatment

An Open-Label, Flexible-Dosing, Multicentre Study

Authors: Prof Steven E. Swift, Paul Siami, Sergio Forero-Schwanhaeuser

Published in: Clinical Drug Investigation | Issue 5/2009

Abstract

Objective: We report outcomes from the VERSUS (VESIcare® Efficacy and Research Study US) study in a cohort with severe overactive bladder (OAB), defined as patients with a score ≥5 on the Patient Perception of Bladder Condition (PPBC) scale at baseline (on tolterodine extended release [ER] 4mg/day) who remained severe at post-washout (on no drug).

Methods: VERSUS was a 12-week, open-label, flexible-dosing study assessing the efficacy, tolerability and effects on health-related quality of life (HRQOL) of solifenacin in patients with OAB. The current study is a post hoc analysis of a severely affected subgroup, as self-defined using the PPBC scale. Patients had received tolterodine ER 4mg/day for ≥4 weeks but wished to switch therapy because of a lack of sufficient subjective improvement in urgency. They had to have continued to have three or more urgency episodes/24 hours at baseline (pre-washout, i.e. while taking tolterodine ER 4mg/day). After ≥14 days’ washout, patients received oral solifenacin 5mg/day, with the option of continuing/adjusting the dose to 5 or 10mg/day at weeks 4 and 8. Diary-documented improvements in urgency, urge incontinence, frequency, nocturia and nocturnal voids were compared with pre-washout (on tolterodine) and post-washout (on no drug) diary entries. The PPBC scale and Overactive Bladder Questionnaire (OAB-q) assessed patient-reported outcomes. Tolerability was evaluated based on the nature, frequency and severity of observed or reported adverse events (AEs).

Results: In this severe OAB cohort, the mean number of urgency episodes/24 hours decreased by 3.95 (95% CI −4.81, −3.08; p <0.0001) from pre-washout (7.38) to study end (3.26). All other diary variables were also significantly reduced (p <0.0001). Patients had a mean PPBC score of 5.3 at pre-washout and 3.6 at study end, representing an improvement of 1.7 (95% CI −2.0, −1.5; p <0.0001). Patients also reported significant improvements for all OAB-q scales and domains (p <0.0001). Treatment-emergent AEs were mostly mild/moderate, and resulted in few discontinuations (5/116, 4.3%).

Conclusion: In patients with severe OAB symptoms, solifenacin was effective and well tolerated. Solifenacin improved urgency, incontinence, micturition frequency, nocturia and nocturnal voids in patients continuing to experience urgency episodes on tolterodine ER 4mg/day. Patients experienced improvements in HRQOL and perceived bother from OAB.

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Title: Diary and Patient-Reported Outcomes in Patients with Severe Overactive Bladder Switching from Tolterodine Extended Release 4mg/day to Solifenacin Treatment
An Open-Label, Flexible-Dosing, Multicentre Study
Authors: Prof Steven E. Swift
Paul Siami
Sergio Forero-Schwanhaeuser
Publication date: 01-05-2009
Publisher: Springer International Publishing
Published in: Clinical Drug Investigation / Issue 5/2009
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI: https://doi.org/10.2165/00044011-200929050-00003

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Diary and Patient-Reported Outcomes in Patients with Severe Overactive Bladder Switching from Tolterodine Extended Release 4mg/day to Solifenacin Treatment

An Open-Label, Flexible-Dosing, Multicentre Study

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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