Efficacy and Tolerability of Solifenacin Fumarate with Overactive Bladder Patients: A Multicenter Observational Study
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Purpose: Overactive bladder (OAB) is characterized by a series of highly prevalent symptoms among older adults. This study used the Overactive Bladder Symptom Score (OABSS) and Patient Perception of Bladder Condition (PPBC) tools to evaluate the efficacy and stability of solifenacin fumarate in the treatment of OAB.Materials and Methods: This was a prospective, multicenter, single-arm, 12-week study that enrolled 163 OAB patients. The patients received 5 mg/day of solifenacin fumarate. The changes in the OABSS, symptoms, and PPBC scores were evaluated at 0, 4, and 12 weeks. Subgroup analysis of the OABSS and PPBC scores based on sex, diabetes mellitus (DM) status, and body mass index (BMI) were also evaluated.Results: At the baseline (week 0), the mean OABSS for all patients was 8.45±2.38(p=0.199). Subsequently, the mean OABSS declined to 5.41±2.69 (p=0.255) at four weeks and 4.21±2.61 (p=0.240) at 12 weeks. The OABSS subscore and PPBC score decreased significantly during the study (p＜0.01). After cases were stratified according to sex, DM status, and BMI, the mean OABSS (mean and subscore) and PPBC score at four and 12 weeks were also improved significantly relative to the baseline scores (both p＜0.05). The overall incidence of adverse events was 7.36% (12 cases), and three patients (1.82%) permanently discontinued solifenacin fumarate because of the adverse events.Conclusions: Solifenacin fumarate is a safe and effective treatment alternative for relieving OAB symptoms, considering the balance between the efficacy, patientsʼwell-being, and tolerability.
Abstract
Purpose: Overactive bladder (OAB) is characterized by a series of highly prevalent symptoms among older adults. This study used the Overactive Bladder Symptom Score (OABSS) and Patient Perception of Bladder Condition (PPBC) tools to evaluate the efficacy and stability of solifenacin fumarate in the treatment of OAB.Materials and Methods: This was a prospective, multicenter, single-arm, 12-week study that enrolled 163 OAB patients. The patients received 5 mg/day of solifenacin fumarate. The changes in the OABSS, symptoms, and PPBC scores were evaluated at 0, 4, and 12 weeks. Subgroup analysis of the OABSS and PPBC scores based on sex, diabetes mellitus (DM) status, and body mass index (BMI) were also evaluated.Results: At the baseline (week 0), the mean OABSS for all patients was 8.45±2.38(p=0.199). Subsequently, the mean OABSS declined to 5.41±2.69 (p=0.255) at four weeks and 4.21±2.61 (p=0.240) at 12 weeks. The OABSS subscore and PPBC score decreased significantly during the study (p＜0.01). After cases were stratified according to sex, DM status, and BMI, the mean OABSS (mean and subscore) and PPBC score at four and 12 weeks were also improved significantly relative to the baseline scores (both p＜0.05). The overall incidence of adverse events was 7.36% (12 cases), and three patients (1.82%) permanently discontinued solifenacin fumarate because of the adverse events.Conclusions: Solifenacin fumarate is a safe and effective treatment alternative for relieving OAB symptoms, considering the balance between the efficacy, patientsʼwell-being, and tolerability.
참고문헌 (18)
- Austin PF, "The standardization of terminology of lower urinary tract function in children and adolescents : update report from the standardization committee of the International Children's Continence Society", Neurourol Urodyn, 35, pp.471~481 (2016)
- Milsom I, "How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study", BJU Int, 87, pp.760~766 (2001)
- Lee YS, "Prevalence of overactive bladder, urinary incontinence, and lower urinary tract symptoms : results of Korean EPIC study", World J Urol, 29, pp.185~190 (2011)
- Irwin DE, "Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries : results of the EPIC study", Eur Urol, 50, pp.1306~1314 (2006)
- Melotti IGR, "Severe depression and anxiety in women with overactive bladder", Neurourol Urodyn, 37, pp.223~228 (2018)
- Kinsey D, "The psychological impact of overactive bladder : a systematic review", J Health Psychol, 21, pp.69~81 (2016)
- Szabo SM, "The association between overactive bladder and falls and fractures : a systematic review", Adv Ther, 35, pp.1831~1841 (2018)
- Matza LS, "Test-retest reliability of four questionnaires for patients with overactive bladder : the overactive bladder questionnaire(OAB-q), patient perception of bladder condition(PPBC), urgency questionnaire(UQ), and the primary OAB symptom questionnaire(POSQ)", Neurourol Urodyn, 24, pp.215~225 (2005)
- Matsukawa Y, "What are factors contributing to improvement of overactive bladder symptoms after alpha-1 blocker treatment in patients with both storage and voiding symptoms?", Urol Int, 103, pp.439~443 (2019)
- Chapple CR, "Solifenacin appears effective and well tolerated in patients with symptomatic idiopathic detrusor overactivity in a placeboand tolterodine-controlled phase 2 dose-finding study", BJU Int, 93, pp.71~77 (2004)
- Sekeroglu MA, "The effect of oral solifenacin succinate treatment on intraocular pressure : glaucoma paradox during overactive bladder treatment", Int Urogynecol J, 25, pp.1479~1482 (2014)
- Chapple CR, "A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial", Eur Urol, 48, pp.464~470 (2005)
- Wang J, "Meta-analysis of the efficacy and safety of mirabegron and solifenacin monotherapy for overactive bladder", Neurourol Urodyn, 38, pp.22~30 (2019)
- Gratzke C, "Long-term safety and efficacy of mirabegron and solifenacin in combination compared with monotherapy in patients with overactive bladder : a randomised, multicentre phase 3 study(SYNERGY II)", Eur Urol, 74, pp.501~509 (2018)
- Wada N, "OAB Study Group in Northern Hokkaido. Efficacy and safety of propiverine and solifenacin for the treatment of female patients with overactive bladder: a crossover study", Low Urin Tract Symptoms, 3, pp.36~42 (2011)
- 김연주, "Cognitive Function and Urologic Medications for Lower Urinary Tract Symptoms", International Neurourology Journal, 24(3), pp.231~240 (2020), 대한배뇨장애요실금학회[DOI]
- Burger M, "Efficacy and tolerability of solifenacin in men with overactive bladder : results of an observational study", World J Urol, 32, pp.1041~1047 (2014)
- Hampel C, "Solifenacin in the elderly : results of an observational study measuring efficacy, tolerability and cognitive effects", Urol Int, 98, pp.350~357 (2017)