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Efficacy and Safety of Solifenacin Succinate in Korean

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Efficacy and Safety of Solifenacin Succinate in Korean doi: 10.1111/j.1742-1241.2008.01898.x ORIGINAL PAPER Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study M.-S. Choo,1 J. Z. Lee,2 J. B. Lee,3 Y.-H. Kim,4 H. C. Jung,5 K.-S. Lee,6 J. C. Kim,7 J. T. Seo,8 J.-S. Paick,9 H.-J. Kim,10 Y. G. Na,11 J. G. Lee12 OnlineOpen: This article is available free online at www.blackwell-synergy.com SUMMARY 1Department of Urology, Asan What’s known Medical Center, University of Purpose: We assessed the efficacy and safety of solifenacin compared with tolte- • Pharmacological management using Ulsan College of Medicine, rodine for treatment of overactive bladder (OAB) in Korean patients. Materials antimuscarinic agents remains the mainstay of Seoul, Korea 2 and methods: The study was randomised, double-blind, tolterodine-controlled therapy and effectively reduces OAB symptoms. Department of Urology, College of Medicine, Pusan trial in Korea. Patients had average frequency of ‡ 8 voids per 24 h and episodes • A new-generation antimuscarinic agent, solifenacin succinate is a once-daily oral agent National University, Busan, of urgency or urgency incontinence ‡ 3 during 3-day voiding diary period. Patients Korea that shows apparent functional selectivity for were randomised to 12-week double-blind treatment with either tolterodine imme- 3Department of Urology, the bladder over other organs in animal models. diate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg National Medical Center, Seoul, • There have been no published comparative data Korea (SOL10) once daily. The outcome measure was mean change in daily micturition between solifenacin and tolterodine in Asian 4Department of Urology, frequency, volume, daily frequency of urgency incontinence, urgency and nocturia individuals. Soonchunhyang University from baseline to week 12. Quality of life was assessed using the King’s Health Bucheon Hospital, Bucheon, Questionnaire. Results: A total of 357 were randomised and 329 were evaluated What’s new Korea 5Department of Urology, for efficacy. All voiding parameters recorded in micturition diary improved after • Compared with tolterodine, the treatment of solifenacin induces the improvement in OAB Yeungnam University Hospital, treatment in all three groups. Mean changes in volume voided were 19.30 ml Daegu, Korea symptom and quality of life in Korean patients (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 6Department of Urology, with OAB. group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was Samsung Medical Center, • This is the first report to compare efficacy and Sungkyunkwan University faster than that of SOL5 and TOL4. Quality of life improved in all three groups. safety of solifenacin succinate with tolterodine School of Medicine, Seoul, Dry mouth was the most common adverse event; its incidence was the lowest in in Asian people with OAB. Solifenacin succinate Korea SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 5 and 10 mg improve OAB symptoms and 7Department of Urology, groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily solifenacin 5 mg is a recommended starting College of Medicine, The dose. Catholic University of Korea, improve OAB symptoms with acceptable tolerability levels compared with toltero- Seoul, Korea dine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients 8Department of Urology, Jeil with OAB. Hospital, Kwandong University College of Medicine, Seoul, Korea 9 therapy, so new agents with proven efficacy and bet- Department of Urology, Seoul Introduction National University College of ter tolerability are required. Medicine, Seoul Korea Overactive bladder (OAB) syndrome has been A new-generation antimuscarinic agent, solifenacin 10Department of Urology, Ò Dankook University College of defined by the International Continence Society as ‘a succinate (Vesicare ; Astellas Pharma Co. Ltd, Tokyo, Medicine, Cheonan, Korea syndrome comprising the symptoms of urgency, with Japan), is a once-daily oral agent that shows apparent 11Department of Urology, or without urgency incontinence, usually with fre- functional selectivity for the bladder over other organs Chungnam National University College of Medicine, Daejeon, quency and nocturia’ (1). Although OAB is not life- in animal models (6). In phase 2 trials, symptomatic Korea threatening, it significantly impairs patients’ quality OAB patients have shown statistically significant 12Department of Urology, of life (2). reductions in voiding frequency and a significant College of Medicine, Korea Pharmacological management using antimuscarinic increase in volume voided per void with doses of 5, 10 University, Seoul, Korea agents remains the mainstay of therapy and effec- and 20 mg once daily (7). In large phase 3 trials, soli- tively reduces OAB symptoms (3). However, despite fenacin 5 or 10 mg once daily demonstrated good effi- the proven efficacy of such agents, their tolerability cacy and tolerability profiles, and these improvements may be limited by adverse events (AEs), mostly dry were maintained in a 40-week open-label extension mouth (4). In fact, these adverse events often lead to study of two of the phase 3 trials (8–12). poor compliance and discontinuation of therapy (5). Until now there have been no published compara- OAB follows a chronic course requiring long-term tive data between solifenacin and tolterodine in ª 2008 The Authors Journal compilation ª 2008 Blackwell Publishing Ltd Int J Clin Pract, November 2008, 62, 11, 1675–1683 1675 1676 Solifenacin succinate in Korean patients with OAB Correspondence to: Asian individuals. In this study, we compared the angle glaucoma and urinary or gastric retention), Jeong Gu Lee, efficacy and tolerability of solifenacin 5 and 10 mg non-pharmacological treatment for OAB including Department of Urology, Korea University Anam Hospital, 126- once daily and tolterodine 2 mg twice daily in electrostimulation therapy or start of a bladder train- 1, 5-ga, anam-dong, Seongbuk- patients with symptoms of OAB. ing programme during the 2 weeks before or during gu, Seoul 136-705, Korea the study, diabetic neuropathy, use of drugs intended Tel.: + 82 2 920 5683 Fax: + 82 2 928 7864 Patients and methods to treat incontinence, use of any drugs with choliner- Email: [email protected] gic or anticholinergic side effects and participation in This multicentre, randomised, double-blind, toltero- a clinical trial within 30 days before study entry. Disclosures The authors have nothing to dine-controlled phase 3 trial was conducted at 16 Women of childbearing potential who were pregnant disclose. university hospitals in Korea. The procedures of this or nursing, intending to become pregnant during the study complied with the guidelines provided by the study, or who were not using reliable contraceptive Trial registration Clinicaltrials.gov identifier: Declaration of Helsinki and were in accordance with methods were ineligible. NCT00189800. the International Conference on Harmonization At an initial screening visit, the patients provided http://clinical Good Clinical Practice guidelines. The study protocol a medical history and underwent a physical examina- trials.gov/ct2/show/ NCT00189800 was approved by the institutional review board at tion, bladder scan for PVR volume, blood and uri- ?term=solifenacin&rank=14 each study site. nalysis and an electrocardiogram. Eligible patients The objectives of the study were to assess efficacy received placebo twice daily (morning and evening) Re-use of this article is permitted in accordance with and tolerability of 12-week treatment with solifenacin over a 2-week run-in period. During the 3 days the Creative Commons Deed, 5 mg (SOL5) and 10 mg (SOL10) compared with before the next visit, patients recorded episodes of Attribution 2.5, which does not 12-week tolterodine immediate-release 4 mg (TOL4) urgency and urgency incontinence, the times of void- permit commercial exploitation. in patients with OAB. At the time of study, the tolte- ing and volumes voided per void in a voiding diary. rodine extended-release (ER) formulation was not After the run-in period, eligible patients were rando- available in Korea. The primary outcome measure mised equally to 12-week double-blind treatment was change in the mean daily micturition frequency with TOL4, SOL5 or SOL10. To maintain blinding, from baseline to end-point. The secondary outcome all patients continued to take medication twice daily measures were changes from baseline in the mean (using placebo tablets and capsules as necessary) dur- micturition volume per voiding, mean daily (24 h) ing the 12-week treatment period. Patients were urgency incontinence frequency, mean daily number regarded compliant if they had taken at least 70% of of urgency episodes, mean daily number of nocturia the required study medication. episodes according to the micturition diary and qual- Adverse events were evaluated for individuals ity of life as assessed by the King’s Health Question- receiving at least one dose of active study medica- naire (13,14). Safety was assessed by AEs, laboratory tion. At each visit, any AE reported in response to tests, vital signs and postvoid residual (PVR) vol- general and non-specific questioning by the investi- umes as measured by bladder scans. gator, or self-reported by the patient was recorded Eligible patients visited the investigational sites for with the severity and likely causality to study medi- screening (visit 1), at the end of the placebo run-in cation. Safety assessments at weeks 4, 8 and 12 period (visit 2) and at weeks 4, 8 and 12 of the dou- included vital signs, physical examinations and AE ble-blind period (visits 3, 4 and 5). Men and women recordings. Laboratory screening and electrocardio- aged ‡ 18 years with symptoms of OAB for gram scans were repeated at the end of the study. ‡ 3 months were eligible for screening and study The PVR volume was assessed by bladder scanning enrolment.
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