Diary and patient-reported outcomes in patients with severe overactive bladder switching from tolterodine extended release 4 mg/day to solifenacin treatment: An open-label, flexible-dosing, multicentre study.
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 >or=5 on the Patient Perception of Bladder Condition (PPBC) scale at baseline (on tolterodine extended release [ER] 4 mg/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 4 mg/day for >or=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 4 mg/day). After >or=14 days' washout, patients received oral solifenacin 5 mg/day, with the option of continuing/adjusting the dose to 5 or 10 mg/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%).


CONCLUSIONS
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 4 mg/day. Patients experienced improvements in HRQOL and perceived bother from OAB.
Medical University of South Carolina, Charleston, South Carolina 29425, USA. swifts@musc.edu
Steven E
SE
Swift
Paul
P
Siami
Sergio
S
Forero-Schwanhaeuser
D000368:Aged; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use; D003408:Cresols / Q000009:adverse effects / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010665:Phenylpropanolamine / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D000069464:Solifenacin Succinate; D011795:Surveys and Questionnaires; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000503:physiopathology
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; D000069464:Solifenacin Succinate