Solifenacin for Overactive Bladder: Patient-Reported Outcomes from a Large Placebo-Controlled Trial

Toglia, Marc R.; Serels, Scott; Laramée, Christine; Karram, Mickey M.; Nandy, Indrani; Andoh, Masakazu; Seifeldin, Raafat; Forero-Schwanhaeuser, Sergio

doi:10.3810/pgm.2009.09.2062

Cited by 21 publications

(8 citation statements)

References 34 publications

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“…Patients’ perceptions of symptom control/bother may also be a factor in a decision to persist with or discontinue treatment. Patients receiving solifenacin for the treatment of OAB have reported significant improvements in health-related quality of life and perceived bother compared with active comparator treatment or placebo [27, 28]. Indeed, unmet treatment expectations and/or tolerability are the primary reasons for treatment discontinuation in up to 90% of non-persistent patients [29].…”

Section: Discussionmentioning

confidence: 99%

A retrospective study of treatment persistence and adherence to α-blocker plus antimuscarinic combination therapies, in men with LUTS/BPH in the Netherlands

et al. 2017

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BackgroundTo assess treatment persistence and adherence in men ≥45 years of age with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), using prescription records from the Netherlands IMS Lifelink™ LRx database.MethodsIn this retrospective, observational cohort study, we identified men who received combination therapy with an α-blocker plus an antimuscarinic (e.g. solifenacin or tolterodine) between 1 November 2013 and 31 October 2014. Treatment could be received as a fixed-dose combination (FDC) tablet or as two drugs administered together (concomitant therapy), if both combination drugs were prescribed within 30 days. The primary objective was to assess treatment persistence, defined as the time from initiation of combination therapy until first discontinuation of the FDC or at least one of the drugs given concomitantly (i.e. ≥30 days without prescription renewal). Subgroup and sensitivity analyses were conducted to assess persistence by antimuscarinic agent, and with different gap lengths used to define discontinuation (45, 60 and 90 days), respectively.ResultsA total of 1891 men received an α-blocker plus an antimuscarinic (FDC, N = 665; concomitant therapy, N = 1226). Median time to discontinuation was significantly longer with FDC versus concomitant therapy (414 vs. 112 days; adjusted hazard ratio [HR] 2.04, 95% confidence interval 1.77, 2.35; p < 0.0001). Persistence at 12 months (51.3% vs. 29.9%) was also significantly greater with FDC compared with concomitant therapy. Assessment of antimuscarinic subgroups showed that median time to discontinuation was longest with solifenacin combinations (214 days) compared with other antimuscarinic combinations (range, 47–164 days; adjusted HR range, 1.27–1.77, p = 0.037). No observable impact on treatment persistence was found by adjusting the gaps used to define discontinuation.DiscussionThis study of real-world evidence of men with LUTS/BPH treated with α-blocker plus antimuscarinic combination therapy in the Netherlands showed that treatment persistence was significantly greater in those who received a FDC tablet compared with combination therapy given concomitantly. The study also shows that treatment persistence was extended in men who received combination therapy containing solifenacin compared with other antimuscarinics.ConclusionsOverall, these findings may be useful for prescribers, as improved persistence on-treatment may translate into improved outcomes for men with LUTS/BPH. Further study is warranted to establish the key drivers of persistence in men receiving combination therapy for LUTS/BPH.Electronic supplementary materialThe online version of this article (doi:10.1186/s12894-017-0226-2) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

A retrospective study of treatment persistence and adherence to α-blocker plus antimuscarinic combination therapies, in men with LUTS/BPH in the Netherlands

et al. 2017

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“…A total of 13 publications were identified, from which ten unique studies were included in the review ( Fig. 1) [6,7,[9][10][11][12][13][14][15][16][17][18][19]. The characteristics and quality of the included studies are presented in Table 1.…”

Section: Literature Flowmentioning

confidence: 99%

“…Characteristic and quality of included studiesToglia et al 2009 [11] Toglia et al 2010[12] Serels et al 2010[13] Chapple et al 2005[6] episodes per 24 h and micturitions per 24 h from baseline to the endpoint, including 2,008 patients with OAB. Heterogeneity was not observed within the subgroups or in the overall analysis (I 2 00%).…”

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confidence: 99%

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

et al. 2012

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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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“…Große randomisierte Studien beschreiben die Therapie mit modernen Anticholinergika wie beispielsweise Solifenacin als effektiv und sicher [17,18,20,21]. Allerdings sind gerade Männer in den meisten Studien zur Wirkung von Antimuskarinika unterrepräsentiert.…”

Section: Diskussionunclassified

“…Allerdings sind gerade Männer in den meisten Studien zur Wirkung von Antimuskarinika unterrepräsentiert. Es gibt für Solifenacin auch zu Männern Daten aus randomisierten Studien, die eine hohe Wirksamkeit und Sicherheit nahelegen [20,21]; dennoch ist eine Übertragbarkeit randomisierter Studien auf die tägliche Praxis nicht verlässlich gegeben [12].…”

Section: Diskussionunclassified

Therapie der überaktiven Blase

Rothe¹,

Kalchthaler

Mühlich

2011

Urologe

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Solifenacin for Overactive Bladder: Patient-Reported Outcomes from a Large Placebo-Controlled Trial

Abstract: Flexibly dosed, once-daily solifenacin was associated with statistically significant and clinically meaningful improvements in urgency and other symptom-specific bother and HRQL compared with placebo.

Cited by 21 publications

References 34 publications

A retrospective study of treatment persistence and adherence to α-blocker plus antimuscarinic combination therapies, in men with LUTS/BPH in the Netherlands

A retrospective study of treatment persistence and adherence to α-blocker plus antimuscarinic combination therapies, in men with LUTS/BPH in the Netherlands

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

Therapie der überaktiven Blase

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