PMID- 19366272
OWN - NLM
STAT- MEDLINE
DCOM- 20090709
LR  - 20211020
IS  - 1173-2563 (Print)
IS  - 1173-2563 (Linking)
VI  - 29
IP  - 5
DP  - 2009
TI  - 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.
PG  - 305-16
LID - 10.2165/00044011-200929050-00003 [doi]
AB  - 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%). 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 4 mg/day. Patients experienced 
      improvements in HRQOL and perceived bother from OAB.
FAU - Swift, Steven E
AU  - Swift SE
AD  - Medical University of South Carolina, Charleston, South Carolina 29425, USA. 
      swifts@musc.edu
FAU - Siami, Paul
AU  - Siami P
FAU - Forero-Schwanhaeuser, Sergio
AU  - Forero-Schwanhaeuser S
LA  - eng
SI  - ClinicalTrials.gov/NCT00454740
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Cresols)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Muscarinic Antagonists)
RN  - 0 (Quinuclidines)
RN  - 0 (Tetrahydroisoquinolines)
RN  - 33RU150WUN (Phenylpropanolamine)
RN  - 5T619TQR3R (Tolterodine Tartrate)
RN  - KKA5DLD701 (Solifenacin Succinate)
SB  - IM
MH  - Aged
MH  - Benzhydryl Compounds/adverse effects/therapeutic use
MH  - Cresols/adverse effects/therapeutic use
MH  - Delayed-Action Preparations
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscarinic Antagonists/adverse effects/*therapeutic use
MH  - Phenylpropanolamine/adverse effects/therapeutic use
MH  - Quality of Life
MH  - Quinuclidines/adverse effects/*therapeutic use
MH  - Severity of Illness Index
MH  - Solifenacin Succinate
MH  - Surveys and Questionnaires
MH  - Tetrahydroisoquinolines/adverse effects/*therapeutic use
MH  - Tolterodine Tartrate
MH  - Treatment Outcome
MH  - Urinary Bladder, Overactive/*drug therapy/physiopathology
EDAT- 2009/04/16 09:00
MHDA- 2009/07/10 09:00
CRDT- 2009/04/16 09:00
PHST- 2009/04/16 09:00 [entrez]
PHST- 2009/04/16 09:00 [pubmed]
PHST- 2009/07/10 09:00 [medline]
AID - 3 [pii]
AID - 10.2165/00044011-200929050-00003 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2009;29(5):305-16. doi: 10.2165/00044011-200929050-00003.