Efficacy and Tolerability of Solifenacin in Patients Aged ⩾ 65 Years with Overactive Bladder: Post-Hoc Analysis of 2 Open-Label Studies

Capo, James P.; Lucente, Vincent; Forero-Schwanhaeuser, Sergio; He, Weizhong

doi:10.3810/pgm.2011.01.2250

Cited by 13 publications

(4 citation statements)

References 28 publications

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“…Because we did not analyze the placebo effect, we cannot conclude that mirabegron improved subjective symptoms in HAM/TSP patients with OAB. Furthermore, the washout period in the present study is shorter than in other studies using sustained‐release and extended‐release formulations, such as solifenacin succinate and fesoterodine fumarate . However, the present study has demonstrated, for the first time, that oral mirabegron therapy improved subjective symptoms, as measured by the IPSS and OABSS, in HAM/TSP patients with OAB.…”

Section: Discussioncontrasting

confidence: 60%

Efficacy of mirabegron for overactive bladder with human T cell lymphotropic virus‐1 associated myelopathy

Matsuo

Miyata

Nakamura

et al. 2018

LUTS

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Objective: Mirabegron is widely considered as an effective and safe drug for patients with overactive bladder (OAB). However, there is no evidence regarding the efficacy of mirabegron in human T cell lymphotropic virus-1 (HTLV-1)-associated myelopathy/tropical spastic paraparesis (HAM/TSP) patients with OAB symptoms. The aim of the present study was to clarify the efficacy of mirabegron in HAM/TSP patients with OAB symptoms.Methods: The present study evaluated the efficacy of mirabegron treatment (50 mg, once daily) in nineteen HAM/TSP patients with OAB symptoms by assessing subjective symptoms using the overactive bladder symptom score (OABSS) and International Prostate Symptom Score (IPSS) before and 12 weeks after administration. Voided volume (VV), maximum flow rate (Q max ), and post-void residual (PVR) urine volume were evaluated as objective symptoms.

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Section: Discussioncontrasting

confidence: 60%

Efficacy of mirabegron for overactive bladder with human T cell lymphotropic virus‐1 associated myelopathy

Matsuo

Miyata

Nakamura

et al. 2018

LUTS

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“…A total of 3078 abstracts, 300 of which underwent full-text screening, were identified using the search criteria. After the exclusion of studies with overlapping populations that provided no additional data [20][21][22][23][24][25][26][27], 20 articles reporting on 21 RCTs were eligible for data extraction and synthesis [23,[28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46]. Following the feasibility assessment, 14 were included in the NMA [23, 28-32, 36, 38-41, 43-45] [Fig.…”

Section: Systematic Literature Review Resultsmentioning

confidence: 99%

Comparative Safety and Efficacy of Treatments for Overactive Bladder Among Older Adults: A Network Meta-analysis

et al. 2020

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Background Cumulative exposure to one or more anticholinergic medications ("anticholinergic burden") is associated with an increased risk of adverse outcomes, particularly among older individuals. Mirabegron, an oral selective β3-adrenergic receptor agonist, has demonstrated efficacy in managing the symptoms of overactive bladder without contributing to anticholinergic burden. However, it is not known whether the favorable safety profile of mirabegron relative to antimuscarinics varies with increasing age among a patient population who may have a high anticholinergic burden. Objective The primary objective of this study was to indirectly compare the safety and efficacy profile of mirabegron relative to antimuscarinics in older adults with overactive bladder. Methods A systematic literature review was conducted to identify randomized controlled trials that reported safety and efficacy endpoints among patients aged ≥ 65 years. Identified randomized controlled trials were subsequently synthesized via a network meta-analysis. Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines in designing, performing, and reporting the literature review were followed. In line with current best practices, the network meta-analysis was conducted using a Bayesian approach and according to the overall general guidance for evidence synthesis developed by the National Institute for Health and Care Excellence decision support unit. Estimates of relative safety were assessed via the odds ratio and estimates of relative efficacy were assessed via means and credible intervals. Results A total of 3078 abstracts, 300 of which underwent full-text screening, were identified using the search criteria. Twenty articles reporting on 21 randomized controlled trials were eligible for data extraction and synthesis. Following review, five safety and five efficacy endpoints were considered for inclusion in the network meta-analysis. Regarding findings typical of anticholinergic exposure in older adults, mirabegron was not associated with an increased odds of dry mouth (odds ratio 95% credible interval 0.76 [0.26-2.37]) or constipation (1.08 [0.39-3.02]) relative to placebo, whereas antimuscarinics were strongly associated with these events (odds ratio range 3.78-7.85 and 2.12-4.66, respectively). In this older population, mirabegron was associated with a similar odds of experiencing adverse event-related treatment discontinuations relative to placebo (0.99 [0.57-1.70]), while the odds of experiencing an adverse event-related treatment discontinuation for antimuscarinics had a range of 1.14-3.03 (in most cases, the association was mild). No increased odds of experiencing overall treatment-emergent adverse events was observed for mirabegron or antimuscarinics (odds ratio range 1.25-1.55), apart from fesoterodine (2.23 [1.37-3.37]). Finally, a similar treatment effect was observed across all efficacy endpoints between mirabegron and antimuscarinics in this older population. Conclusions This study indicates that the safety and effica...

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“…Solifenacin has well-documented effectiveness in treatment of patients with OAB. Two open multicentric clinical phase III trials – VOLT ( VESIcare Open-Label Trail ) and VERSUS ( VESIcare Efficacy and Research Study ) [ 11 ] – have documented the efficiency and safety of using this drug. A 12-week treatment significantly reduced the number of urgent episodes, episodes of incontinence and nocturia, and improved quality of life.…”

Section: Discussionmentioning

confidence: 99%

Post-Irradiation Bladder Syndrome After Radiotherapy of Malignant Neoplasm of Small Pelvis Organs: An Observational, Non-Interventional Clinical Study Assessing VESIcare®/Solifenacin Treatment Results

et al. 2016

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BackgroundRadiotherapy is explicitly indicated as one of the excluding factors in diagnosing overactive bladder syndrome (OAB). Nevertheless, symptoms of OAB such as urgent episodes, incontinence, pollakiuria, and nocturia, which are consequences of irradiation, led us to test the effectiveness of VESIcare®/Solifenacin in patients demonstrating these symptoms after radiation therapy of small pelvis organs due to malignant neoplasm.Material/MethodsWe conducted an observatory clinical study including 300 consecutive patients with symptoms of post-irradiation bladder; 271 of those patients completed the study. The observation time was 6 months and consisted of 3 consecutive visits taking place at 12-week intervals. We used VESIcare® at a dose of 5 mg a day. Every sixth patient was examined urodynamically at the beginning and at the end of the observation period, with an inflow speed of 50 ml/s.ResultsWe noticed improvement and decline in the average number of episodes a day in the following parameters: number of micturitions a day (−36%, P<0.01), nocturia (−50%, P<0.01), urgent episodes (−41%, P<0.03), and episodes of incontinence (−43%, P<0.01). The patients’ quality of life improved. The average maximal cystometric volume increased by 34 ml (21%, p<0.01), average bladder volume of “first desire” increased by 42 ml (49%, P<0.01), and average detrusor muscle pressure at maximal cystometric volume diminished by 9 cmH2O (−36%, P<0.03).ConclusionsThe substance is well-tolerated. Solifenacin administered long-term to patients with symptoms of OAB after radiotherapy of a malignant neoplasm of the small pelvis organs has a daily impact in decreasing number of urgent episodes, incontinence, pollakiuria, and nocturia.

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Efficacy and Tolerability of Solifenacin in Patients Aged ⩾ 65 Years with Overactive Bladder: Post-Hoc Analysis of 2 Open-Label Studies

Cited by 13 publications

References 28 publications

Efficacy of mirabegron for overactive bladder with human T cell lymphotropic virus‐1 associated myelopathy

Efficacy of mirabegron for overactive bladder with human T cell lymphotropic virus‐1 associated myelopathy

Comparative Safety and Efficacy of Treatments for Overactive Bladder Among Older Adults: A Network Meta-analysis

Post-Irradiation Bladder Syndrome After Radiotherapy of Malignant Neoplasm of Small Pelvis Organs: An Observational, Non-Interventional Clinical Study Assessing VESIcare®/Solifenacin Treatment Results

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