Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: Results of a 12-week, multicenter, open-label, flexible-dose study

Chancellor, Michael B.; Zinner, Norman R.; Whitmore, Kristene; Kobashi, Kathleen C.; Snyder, Jeffrey A.; Siami, Paul; Karram, Mickey M.; Laramée, Christine; Capo, James P.; Seifeldin, Raafat; Forero-Schwanhaeuser, Sergio; Nandy, Indrani

doi:10.1016/j.clinthera.2008.10.011

Cited by 46 publications

(37 citation statements)

References 36 publications

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“…Phase IIIa clinical studies have demonstrated solifenacin also to be an effective treatment for patients who are dissatisfied with their prior antimuscarinic treatment (unpublished pooled data from two placebo-controlled studies) [Cardozo et al 2004;Chapple et al 2004]. Solifenacin not only reduced OAB symptoms but also improved HRQoL in OAB patients who were switched from tolterodine ER 4 mg [Karram and Chancellor, 2006;Chancellor et al 2008]. Mirabegron has been approved for treatment of OAB in several regions in the world, including the USA, Europe, Japan, Canada and Australia.…”

Section: Discussionmentioning

confidence: 99%

“…Prescribing an alternative antimuscarinic, such as solifenacin or darifenacin, has improved symptoms in patients previously dissatisfied with efficacy [Karram and Chancellor, 2006;Zinner et al 2008;Chancellor et al 2008]; however, the potential for bothersome anticholinergic AEs may hinder long-term persistence. A post hoc subgroup analysis of phase III clinical trial data suggested that patients who discontinued at least one prior antimuscarinic due to insufficient efficacy benefited from mirabegron (50 and 100 mg), whereas patients receiving tolterodine extended-release (ER) 4 mg demonstrated a placebo-like effect ].…”

Section: Introductionmentioning

confidence: 99%

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The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial

Batista

Kölbl

Herschorn

et al. 2015

Therapeutic Advances in Urology

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Objective: To compare the efficacy and safety of mirabegron 50 mg and solifenacin 5 mg in overactive bladder (OAB) patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy. Patients and methods: This randomized, double-blind, phase IIIb, noninferiority study, enrolled male and female patients aged ⩾18 years old, with symptoms of OAB for ⩾3 months, who were dissatisfied with their previous antimuscarinic drug due to lack of efficacy. A total of 1887 patients were randomized to receive mirabegron 50 mg (n = 943) or solifenacin 5 mg (n = 944) daily for 12 weeks. The primary efficacy endpoint was change from baseline to end of treatment in mean number of micturitions/24 h. Noninferiority was confirmed if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference between solifenacin and mirabegron was > −0.20. Secondary efficacy endpoints, which included change from baseline in mean number of incontinence episodes/24 h, urgency incontinence episodes/24 h, urgency episodes (grade 3 or 4)/24 h and nocturia episodes/24 h, were analyzed using analysis of covariance. Results: For the primary endpoint, adjusted mean treatment difference (95% CI) in mean number of micturitions/24 h was −0.18 (−0.42, 0.06) and therefore noninferiority of mirabegron to solifenacin was not demonstrated. Both treatments demonstrated clinically meaningful reductions in efficacy variables and were well tolerated, with a lower incidence of dry mouth with mirabegron. Conclusions: Noninferiority of mirabegron compared with solifenacin for reduction in micturition frequency could not be demonstrated in this population of OAB patients who were dissatisfied with previous antimuscarinic therapy due to lack of efficacy. Both mirabegron and solifenacin improved key OAB symptoms with no statistically significant differences observed between the two treatments. Both drugs were well tolerated.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial

Batista

Kölbl

Herschorn

et al. 2015

Therapeutic Advances in Urology

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show abstract

“…In clinical practice, most urologists would try another anticholinergic for patients who fail one anticholinergic before considering a combination of two antimuscarinics. [17][18][19] These studies also did not include a placebo arm or direct comparator, and, therefore, might be open to physician and patient bias. Further research should encompass this issue to ensure the efficacy of simply changing anticholinergics or combined medication in real practice.…”

Section: Drug Combinations Nmentioning

confidence: 99%

Efficacy and tolerability of combined medication of two different antimuscarinics for treatment of adults with idiopathic overactive bladder in whom a single agent antimuscarinic therapy failed

Jeong

Chung

et al. 2013

CUAJ

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Objective: Recent studies have investigated a combination of two antimuscarinics for adult neurogenic bladder managed with clean intermittent catheterization or pediatric refractory overactive bladder (OAB). We assessed the efficacy and tolerability of this strategy in adults with idiopathic OAB. Methods: We reviewed 49 patients with idiopathic OAB who received combined antimuscarinic medication. Patients had serially received different kinds of antimuscarinics as monotherapy, but wished to take combined medication due to a lack of sufficient subjective improvement in urgency, even with dosage escalation. Efficacy was measured by changes of episodes of urgency, daytime voiding, nocturia and mean voided volume before and after the addition of the second antimuscarinic. Results: The mean duration of combined medication was 9.3 months. After adding the second antimuscarinic, urgency per day decreased from 3.8 to 1.9 (p < 0.001) and daytime voiding decreased from 10.4 to 7.4 (p < 0.001). The number of nocturia episodes and the mean voided volume also improved, although there was no statistical significance. Efficacy did not differ between the 29 cases, with non-selective and non-selective drugs and 20 cases with non-selective and M3 selective drugs. Thirty-three (67.3%) patients reported to have benefited from combined medication. Maximal flow rate and post-void residual volume did not change in either of the sexes. Eleven (22.4%) patients discontinued the combination due to continued ineffectiveness and dry mouth. Conclusion: This retrospective study suggests that combined medication can help adults with refractory idiopathic OAB. Combined medication was tolerated in most of our patients.

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“…Chancellor et al 63 conducted a multi-center, openlabel,flexible-dosestudyontheefficacy,tolerability, and effects of Solifenacin on HRQoL in 606 patients previously treated with Tolterodine ER and who wishedtoswitchtherapybecauseofinsufficientsubjective improvement of urgency. Among these patients with residual urgency after treatment with Tolterodine ER4mg,Solifenacinwasassociatedwithsignificant amelioration of urgency and other diary-documented OAB symptoms as well as enhancement of HRQoL and perceived OAB bother.…”

Section: Solifenacinmentioning

confidence: 99%

Clinical Use of Tolterodine Extended Release in Overactive Bladder

Adli

Corcos

2012

Clin Med�Insights�Urol

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Abstract:Overactive bladder (OAB) is a common problem whose prevalence increases with advancing age and compromises health-relatedqualityoflife.TolterodinewasthefirstantimuscarinicdrugspecificallydesignedtotreatOAB. ThroughMEDLINE,wereviewedarticles,standardizationreportsandmeetingabstracts,publishedbetween2001and2011,ontheefficacy and tolerability of Tolterodine extended release (ER). Our search terms included Tolterodine, extended release, overactive bladder, therapeuticuse,efficacy,tolerance,andadverseevents. TolterodineER,viasteadydrugreleaseduringthedaytime,givesthebenefitofconstantserumconcentrationandthusbetterefficacy and tolerability in comparison to Tolterodine immediate release, even in elderly patients with co-morbid conditions.

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Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: Results of a 12-week, multicenter, open-label, flexible-dose study

Cited by 46 publications

References 36 publications

The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial

The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial

Efficacy and tolerability of combined medication of two different antimuscarinics for treatment of adults with idiopathic overactive bladder in whom a single agent antimuscarinic therapy failed

Clinical Use of Tolterodine Extended Release in Overactive Bladder

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