PMID- 19014833 OWN - NLM STAT- MEDLINE DCOM- 20090209 LR - 20220317 IS - 0149-2918 (Print) IS - 0149-2918 (Linking) VI - 30 IP - 10 DP - 2008 Oct TI - Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: results of a 12-week, multicenter, open-label, flexible-dose study. PG - 1766-81 LID - 10.1016/j.clinthera.2008.10.011 [doi] AB - OBJECTIVE: This study evaluated the use of solifenacin in patients experiencing residual urgency symptoms during treatment with tolterodine extended release (ER) 4 mg for overactive bladder (OAB). METHODS: This was a 12-week, multicenter, openlabel, flexible-dose study of the efficacy, tolerability, and effects on health-related quality of life (HRQL) of solifenacin in patients aged >or=18 years who had symptoms of OAB for >or=3 months, had been treated with tolterodine ER 4 mg for >or=4 weeks, and wished to switch therapy because of a lack of sufficient subjective improvement in urgency. At baseline (before washout of tolterodine), patients had to have >or=3 urgency episodes/24 hours. After >or=14 days' washout of tolterodine, all patients received oral solifenacin 5 mg/d, with the option of a dose increase to 10 mg at weeks 4 and 8. On 3 consecutive days before the prewashout, postwashout (no drug treatment for OAB), and week 4, 8, and 12 visits (during and at the end of treatment with solifenacin), patients used a bladder diary to document daily symptoms of urgency, urge incontinence, frequency, nocturia, and nocturnal voids. Changes in these measures at study end were compared with prewashout and postwashout values. The Patient Perception of Bladder Condition (PPBC) and Overactive Bladder Questionnaire (OAB-q) were used to assess patient-reported outcomes at prewashout, postwashout, and week 12. Tolerability was evaluated based on the nature, frequency, and severity of observed or reported adverse events (AEs). RESULTS: Of 606 patients screened, 441 received study medication (mean [SD] age, 61.4 [13.8] years; 88.9% white; 88.2% female). Diary-documented urgency changed from a mean of 6.0 episodes/24 hours at prewashout to 2.6 episodes/24 hours at study end, a mean decrease of 3.4 episodes/24 hours (95% CI, -3.8 to -3.0; P < 0.001). The frequency of all other diary variables was also significantly reduced from prewashout to study end (P < 0.001). The mean PPBC score changed from 4.2 points at prewashout to 3.0 points at study end, a mean improvement of 1.2 points (95% CI, -1.3 to -1.1; P < 0.001). Changes in all OAB-q scales and domains (symptom bother, coping, concern, sleep, social interaction, and total HRQL) from prewashout and postwashout to study end were also statistically significant (P < 0.001). Treatment-emergent AEs were mainly mild or moderate (237/261 [90.8%]) and led to few discontinuations (16/441 [3.6%]). Treatment-emergent AEs included anticholinergic AEs such as dry mouth (77 [17.5%]), constipation (51 [11.6%]), and blurred vision (10 [2.3%]). CONCLUSIONS: Among these patients with residual urgency after treatment with tolterodine ER 4 mg, solifenacin was associated with significant improvements in urgency and other diary-documented symptoms of OAB. Patients receiving solifenacin also had significant improvements in HRQL and the perceived bother of OAB. FAU - Chancellor, Michael B AU - Chancellor MB AD - Department of Urology, William Beaumont Hospital, Royal Oak, Michigan 48073, USA. michael.chancellor@beaumont.edu FAU - Zinner, Norman AU - Zinner N FAU - Whitmore, Kristene AU - Whitmore K FAU - Kobashi, Kathleen AU - Kobashi K FAU - Snyder, Jeffrey A AU - Snyder JA FAU - Siami, Paul AU - Siami P FAU - Karram, Mickey AU - Karram M FAU - Laramee, Christine AU - Laramee C FAU - Capo', James P Jr AU - Capo' JP Jr FAU - Seifeldin, Raafat AU - Seifeldin R FAU - Forero-Schwanhaeuser, Sergio AU - Forero-Schwanhaeuser S FAU - Nandy, Indrani AU - Nandy I LA - eng SI - ClinicalTrials.gov/NCT00454740 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 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 - Benzhydryl Compounds/administration & dosage/*therapeutic use MH - Cresols/administration & dosage/*therapeutic use MH - Delayed-Action Preparations MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Male MH - Middle Aged MH - Muscarinic Antagonists/administration & dosage/adverse effects/*therapeutic use MH - Phenylpropanolamine/administration & dosage/*therapeutic use MH - Quinuclidines/administration & dosage/adverse effects/*therapeutic use MH - Solifenacin Succinate MH - Tetrahydroisoquinolines/administration & dosage/adverse effects/*therapeutic use MH - Tolterodine Tartrate MH - Urinary Bladder, Overactive/*drug therapy EDAT- 2008/11/19 09:00 MHDA- 2009/02/10 09:00 CRDT- 2008/11/19 09:00 PHST- 2008/09/18 00:00 [accepted] PHST- 2008/11/19 09:00 [pubmed] PHST- 2009/02/10 09:00 [medline] PHST- 2008/11/19 09:00 [entrez] AID - S0149-2918(08)00332-9 [pii] AID - 10.1016/j.clinthera.2008.10.011 [doi] PST - ppublish SO - Clin Ther. 2008 Oct;30(10):1766-81. doi: 10.1016/j.clinthera.2008.10.011.