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

• Published in: Clinical drug investigation 2009, Vol.29 (5), p.305-316
• Main Authors: Swift, Steven E., Siami, Paul, Forero-Schwanhaeuser, Sergio
• Format: Article
• Language: English
• Subjects: Internal Medicine; Medicine; Medicine & Public Health; Original Research Article; Pharmacology/Toxicology; Pharmacotherapy
• ISSN: 1173-2563; 1179-1918
• DOI: 10.2165/00044011-200929050-00003

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