Solifenacin for overactive bladder: A systematic review and meta-analysis

Department of Urology, West China Hospital, Sichuan University, Guoxue Xiang #37, Chengdu, Sichuan 610041, People's Republic of China.
International Urogynecology Journal (Impact Factor: 1.96). 02/2012; 23(8):983-91. DOI: 10.1007/s00192-011-1641-7
Source: PubMed


This study aims to evaluate the efficacy and safety of solifenacin for treating overactive bladder. Randomized controlled trials (RCTs) were identified and extracted from MEDLINE, Embase, and CENTRAL. The quality of the included RCTs was assessed using the Jadad score, and heterogeneity was analyzed using the chi-squared test. The data of the included RCTs were collected, extracted, and assessed by our protocol. A total of nine RCTs were identified from the search strategy. Compared with the placebo and tolterodine treatments, both short-term (mostly 12-week) trials indicated that solifenacin significantly reduced urgency episodes, micturitions, and incontinence episodes per 24 h. Compared with the solifenacin (5 mg) group, the solifenacin (10 mg) group was significantly better in terms of the number of micturitions per 24 h. With regard to adverse effects, the patients treated with solifenacin had significantly higher rates of constipation and blurred vision than patients treated with tolterodine. The solifenacin therapy was not inferior to tolterodine in terms of efficacy profiles and had a similar incidence of overall adverse events compared with tolterodine treatment. Solifenacin (5 mg) is thus a recommended dose because of its reported balance between efficacy and acceptable tolerability.

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    ABSTRACT: BACKGROUND: Storage symptoms are often undertreated in men with lower urinary tract symptoms (LUTS). OBJECTIVE: To evaluate the combination of an antimuscarinic (solifenacin) with an a-blocker (tamsulosin) versus tamsulosin alone in the treatment of men with LUTS. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, 12-wk, phase 2 study in 937 men with LUTS (=3 mo, total International Prostate Symptom Score [IPSS] =13, and maximum urinary flow rate 4.0-15.0ml/s). INTERVENTION: Eight treatment groups: tamsulosin oral controlled absorption system (OCAS) 0.4mg; solifenacin 3, 6, or 9mg; solifenacin 3, 6 or 9mg plus tamsulosin OCAS 0.4mg; or placebo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary efficacy end point was change from baseline in total IPSS. Secondary end points included micturition diary and quality-of-life (QoL) parameters. Post hoc subgroup analyses were performed by severity of baseline storage symptoms, with statistical comparisons presented only for tamsulosin OCAS alone versus combination therapy, due to the small sample size of the solifenacin monotherapy and placebo subgroups. RESULTS AND LIMITATIONS: Combination therapy was associated with significant improvements in micturition frequency and voided volume versus tamsulosin OCAS alone in the total study population; improvements in total IPSS were not significant. Statistically significant improvements in urgency episodes, micturition frequency, total urgency score, voided volume, IPSS storage subscore, IPSS-QoL index, and Patient Perception of Bladder Condition were observed in a subpopulation of men with two or more urgency episodes per 24h (Patient Perception of Intensity of Urgency Scale grade 3 or 4) and eight or more micturitions per 24h at baseline (storage symptoms subgroup) with combination therapy versus tamsulosin OCAS alone (p=0.05 for the dose-response slope, all variables). Combination therapy was well tolerated, and adverse events were consistent with the safety profiles of both compounds. CONCLUSIONS: Solifenacin plus tamsulosin OCAS did not significantly improve IPSS in the total study population but offered significant efficacy and QoL benefits over tamsulosin OCAS monotherapy in men with both voiding and storage symptoms at baseline. Combination therapy was well tolerated. CLINICALTRIALS.GOV IDENTIFIER: NCT00510406.
    European Urology 03/2013; 64(3). DOI:10.1016/j.eururo.2013.03.031 · 13.94 Impact Factor
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    ABSTRACT: Introduction: The potential impact of antimuscarinics (AMs) on cardiac function is a major concern in the treatment of overactive bladder (OAB) patients, especially in older ones who are likely to present cardiovascular (CV) comorbidities and other risk factors that may predispose them to the adverse cardiac effects of this therapy. Areas covered: This article aims to review the literature on the impact on the CV system of AMs used in the treatment of OAB, giving a comprehensive explanation of the pathogenetic mechanisms of AMs' effects on CV system and the impact of each AM drug on cardiac function. Expert opinion: Although the CV safety of AM drugs seems to be good, evidence provided in this manuscript does not allow to exclude an increase in HR, QT prolongation or an increase in the CV risk due to drug-drug interactions in OAB patients who are usually elderly and have comorbidities. Clinical and electrocardiographic monitoring may be necessary throughout the administration period in selected populations such as patients aged > 80 years, those with coronary heart disease or congestive heart failure. Further studies are needed to understand whether the most recently developed AM drugs, such as imidafenacin, are safer than the old ones.
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