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Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study

Cited 23 time in Web of Science Cited 25 time in Scopus
Authors
Choo, M-S; Lee, J Z; Lee, J B; Kim, Y-H; Jung, H C; Lee, K-S; Kim, J C; Seo, J T; Paick, J-S; Kim, H-J; Na, Y G; Lee, J G
Issue Date
2009-01-16
Publisher
Wiley-Blackwell
Citation
Int J Clin Pract. 2008; 62(11): 1675-1683
Keywords
AdultAgedAged, 80 and overDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedMuscarinic Antagonists/*administration & dosage/adverse effectsNocturia/drug therapy/etiologyPatient SatisfactionProspective StudiesQuinuclidines/*administration & dosage/adverse effectsTetrahydroisoquinolines/*administration & dosage/adverse effectsTreatment OutcomeUrinary Bladder, Overactive/*drug therapyUrinary Incontinence/drug therapy/etiologyUrinary Retention/drug therapy/etiology
Abstract
PURPOSE: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. MATERIALS AND METHODS: The study was randomised, double-blind, tolterodine-controlled trial in Korea. Patients had average frequency of >or= 8 voids per 24 h and episodes of urgency or urgency incontinence >or= 3 during 3-day voiding diary period. Patients were randomised to 12-week double-blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King's Health Questionnaire. RESULTS: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively). CONCLUSIONS: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.
ISSN
1742-1241 (Electronic)
Language
English
URI
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=19143854

https://hdl.handle.net/10371/67938
DOI
https://doi.org/10.1111/j.1742-1241.2008.01898.x
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College of Medicine/School of Medicine (의과대학/대학원)Urology (비뇨기과학전공)Journal Papers (저널논문_비뇨기과학전공)
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