Mirabegron For Overactive Bladder Research Articles

Efficacy and safety of vibegron compared with mirabegron for overactive bladder: A systematic review and network meta-analysis.

The aim of this study was to indirectly compare the efficacy and safety of mirabegron and vibegron in patients with overactive bladder. A systematic search was performed on Pubmed, Web of Science, Embase, and the Cochrane Central Register of Controlled Trials databases to identify studies from the date of database inception to January 1, 2022. All randomized controlled trials comparing mirabegron or vibegron with tolterodine, imidafenacin, or placebo were eligible. One reviewer extracted data, and a second reviewer checked. Included trials were assessed for similarity, and networks were developed using Stata 16.0 software. Mean differences for continuous variables and odds ratios for dichotomous variables together with their 95% confidence intervals (CIs) were used to rank treatments and compare the differences, respectively. A total of 11 randomized controlled trials and 10 806 patients were included. For each outcome, results for all licensed treatment doses were included. Both vibegron and mirabegron were more efficacious than placebo at reducing the frequency of micturition, incontinence, urgency, urgency incontinence, and nocturia. Vibegron was more efficacious than mirabegron in reducing mean voided volume/micturition (95% CI [5.15, 14.98]). Safety outcomes for vibegron and mirabegron were similar to those in the placebo group, except for mirabegron, which had a higher risk of nasopharyngitis and cardiovascular adverse events than placebo. Both drugs seem to be comparable and well tolerated, particularly as direct comparisons are not available. However, vibegron may be more effective than mirabegron in reducing mean voided volume.

Assessing Quality-of-Life of Patients Taking Mirabegron for Overactive Bladder.

Lower urinary tract symptoms (LUTS), including urgency, frequency, and urgency incontinence, are highly prevalent in the general population and increase in prevalence with increasing age. All LUTS, but notable urgency and urgency incontinence, are associated with negative impact on quality-of-life (QoL), with multiple aspects of QoL affected. Urgency and urgency incontinence are most commonly caused by overactive bladder (OAB), the clinical syndrome of urinary urgency, usually accompanied by increased daytime frequency and/or nocturia in the absence of infection or other obvious etiology, which may be treated with conservative and lifestyle interventions, bladder antimuscarinic drugs, and, more recently, by mirabegron, a β3 agonist. This narrative review describes the impact of OAB on QoL, quantifies this impact, and outlines the evidence for the use of mirabegron in the treatment of, and improvement in QoL in, people with OAB.

Mirabegron for overactive bladder in frail patients 80\xa0years or over (HOKUTO study)

BackgroundWe assessed the efficacy and safety of mirabegron, a β3-adrenoceptor agonist, in older adults (≥ 80 years old) with overactive bladder (OAB).MethodsOAB patients aged ≥ 80 years were enrolled in this prospective, single-arm observational study. OAB was diagnosed based on the OAB symptom score (OABSS); i.e., a total score of ≥ 3 points and an urgency score of ≥ 2 points. Patients who received 50 mg mirabegron once daily were evaluated at the baseline and at 4, 8, and 12 weeks. The changes from the baseline in the OABSS, International Prostate Symptom Score (IPSS), OAB questionnaire (OAB-q) score, and Vulnerable Elders Survey (VES-13) score were determined. Adverse events, laboratory tests, 12-lead electrocardiography, the QT interval according to Fridericia’s formula (QTcF), uroflowmetry, the post-void residual urine volume (PVR), and the Mini-Mental State Examination (MMSE) score were used to assess safety.ResultsForty-three patients (median age: 84 years, range: 80–96 years) were examined. They had high rates of comorbidities and polypharmacy. Mirabegron significantly improved in total score of the OABSS, including urgency and urge incontinence. The total IPSS, IPSS quality-of-life (QOL) index, and OAB-q scores also significantly improved. Mirabegron improved in the VES-13 score. There were no significant changes in laboratory test values, uroflowmetry findings, PVR, the QTcF, or MMSE score. Two patients (4.7%) withdrew from the study after experiencing adverse events.ConclusionsMirabegron was well tolerated and significantly improved in OAB symptoms, and QOL in older patients.Trial registration The present clinical study was approved by University of Yamanashi Institutional Review Board prior to study initiation (ID1447) and was retrospectively registered with the UMIN Clinical Trials Registry (UMIN-CTR), Japan (UMIN000045996) on Nov 6, 2021.

Mirabegron in Overactive Bladder and Its Role in Exit Strategy After Botulinum Toxin Treatment in Children.

PurposeMirabegron is a recent addition to the management options of overactive bladder (OAB) in children. The purpose of this study was to ascertain the role of Mirabegron in the treatment algorithm of therapy-resistant OAB especially after botulinum toxin.MethodsCase notes of all children receiving Mirabegron between July 2017 and February 2020 were reviewed.ResultsForty one children (21 females, 20 males), mean age 12.6 [8–17] years old, commenced Mirabegron: 35 idiopathic OAB, 6 neuropathic OAB. The mean duration of treatment was 20.7 [3–45] months. In total 24 (59%) had Mirabegron after partial/no response to anticholinergics, and 17 (41%) patients had Mirabegron subsequent to botulinum toxin A (BtA) as an exit strategy. In total 35 (85%) patients had combination therapy (Mirabegron and anticholinergics), and 6 (15%) patients had Mirabegron only. Fourteen (34%) had complete response, 17 (41%) had partial response, and 10 (24%) had no response. Side effects were reported in 7 (17%) patients with discontinuation necessitated in 3.ConclusionMirabegron when used alone or in combination with anticholinergics resulted in complete/partial response in 76% of anticholinergic therapy-resistant OAB. In addition to being an important step in treatment escalation after no/partial response to anticholinergics, it has a crucial role in the exit strategy for recurring symptoms after BtA wears off.

Efficacy of Vibegron and Mirabegron for Overactive Bladder: A Systematic Literature Review and Indirect Treatment Comparison.

BackgroundIn the absence of head-to-head trials, we performed an indirect treatment comparison of the β3-adrenergic agonists vibegron and mirabegron in the treatment of overactive bladder (OAB).MethodsPubMed, Embase, and Cochrane Library were searched for articles related to phase 3, double-blind, controlled trials of vibegron 75 mg and mirabegron 25/50 mg in patients with OAB. Efficacy outcomes included change from baseline at weeks 4, 12, and 52 in mean daily number of total urinary incontinence episodes and micturitions and mean volume voided/micturition. Effect size was computed as placebo-subtracted change from baseline (weeks 4, 12) or active control (tolterodine)-subtracted change from baseline (week 52) for each treatment group. Adverse events (AEs) are presented descriptively.ResultsAfter removal of duplicates, 49 records were identified, and after screening 9 met inclusion criteria for analysis. Vibegron showed significantly greater reduction in mean daily number of total incontinence episodes than mirabegron 25 mg at week 4, mirabegron 50 mg (weeks 4, 52), and tolterodine (weeks 4, 12) (P < 0.05, each) and significantly greater improvement in volume voided versus mirabegron 25 mg (week 12), mirabegron 50 mg (weeks 12, 52), and tolterodine (week 4) (P < 0.05, each). Confidence intervals of point estimates overlapped zero for all other comparisons of vibegron and mirabegron (25 or 50 mg) or tolterodine, indicating no significant differences between treatments for these time/endpoints. Urinary tract infection, hypertension, and dry mouth were the most commonly occurring AEs for vibegron, mirabegron, and tolterodine, respectively, in the short-term trials; hypertension was the most commonly occurring AE with all three treatments in the long-term trials.ConclusionsVibegron was associated with significant improvement in total incontinence episodes versus mirabegron at 4 and 52 weeks and volume voided at 12 and 52 weeks. Improvement in micturitions was similar between vibegron and mirabegron or tolterodine. Incidence of AEs was generally comparable between vibegron and mirabegron.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01902-8.

Adverse events associated with mirabegron 50 mg versus placebo: A systematic review and meta-analysis

The safety of mirabegron 50mg monotherapy was comprehensively assessed versus placebo for overactive bladder. A systematic literature search was conducted up to June, 2020 using PUBMED, EMBASE and Cochrane Library. Randomized controlled trials evaluating safety of mirabegron in overactive bladder were collected, and safety was assessed according to 15 adverse events. Adverse events were widely selected to be assessed if they could be calculated. Heterogeneity among studies was assessed by using the χ2 test based on the Q and I2 tests. Pooled effect sizes were calculated using fixed model if I2<50%, otherwise a random-effects model was chosen. The outcomes were nasopharyngitis, dry mouth, hypertension, constipation, headache, dyspepsia, urinary tract infection, dizziness, blurred vision, nausea, cardiovascular events, influenza, electrocardiogram QT prolonged, upper respiratory tract infection and high blood pressure. In all, 10 peer-reviewed trials comprising 6135 patients were identified. Compared with placebo, mirabegron 50mg had an unfavorable safety profile resulting in nasopharyngitis (OR, 1.54[95% credible interval, 1.05-2.25]; P=0.03. No statistical difference was found between mirabegron 50mg and placebo groups in other 14 outcomes. Mirabegron 50mg is further confirmed to be nearly as safe as placebo, expect for nasopharyngitis. Nasopharyngitis is associated with mirabegron 50mg monotherapy for patients with overactive bladder.

PUK12 ANALYSIS OF COST AND CONSEQUENCES RELATED TO THE PERSISTENCE OF MIRABEGRON AND ANTIMUSCARINIC TREATMENTS AND THEIR IMPACT ON QUALITY OF LIFE IN PATIENTS AGED ≥ 65 YEARS WITH OVERACTIVE BLADDER IN SPAIN

To evaluate whether a difference in treatment dropout rate with mirabegron in overactive bladder (OAB) patients aged ≥ 65 years could generate cost savings to the National Health System (NHS) and gain quality-adjusted life years (QALYs), compared with the most commonly prescribed antimuscarinics (AM) in Spain (tolterodine, fesoterodine, oxybutynin, solifenacin). A probabilistic model (second order Monte Carlo simulation) in a hypothetical cohort of 1,000 patients aged ≥ 65 years with OAB and a time horizon of 1 year was carried out. Persistence rates, defining treatment discontinuation after a period of at least 30 days without prescription renewal, for both mirabegron and AM were obtained from a Spanish observational study in 1,149 patients ≥ 65 years-old. Unit costs (€ 2019) and utility loss associated to treatment discontinuation were obtained from Spanish public prices and literature, respectively. Persistence rates were higher in patients aged ≥ 65 years treated with mirabegron (20.2%) versus AM (10.2%), leading to a QALY gain of 0.0192 ± 0.0027 QALYs per year. Treatment with mirabegron could generate savings of 68.32 ± 12.19 € per patient per year compared to AM, with a 100% probability of saving (in all patients in the cohort). For the discontinuation criteria at 45, 60 and 90 days, the gain of QALYs with mirabegron versus AM would be 0.0227 ± 0.0058, 0.0225 ± 0.0072 and 0.0230 ± 0.0099, respectively. Saving per patient/year would be 80.75 ± 40.14 €, 78.74 ± 56.23 € and 78.19 ± 83.35 €, respectively. The result was stable for all univariate deterministic sensitivity analyzes. The probabilistic model presented showed a greater persistence in patients aged ≥ 65 years treated with mirabegron compared to AM, leading to a positive impact in OAB patients' quality of life, as well cost savings to the NHS in Spain.

Preliminary experience and possible predictors of successful mirabegron treatment for overactive bladder

ObjectiveThe aim of this study was to report our preliminary experience of the treatment with mirabegron and to identify the predictors of a successful treatment with mirabegron in overactive bladder (OAB) patients. Materials and methodsBetween October 2015 and February 2016, 234 consecutive patients (167 men and 67 women; mean age: 65.6 years; standard deviation: 16.3) diagnosed with OAB and receiving mirabegron monotherapy were enrolled retrospectively. Four weeks after mirabegron treatment, a global response assessment (GRA) was performed for all patients and analyses were performed to identify possible predictors of successful mirabegron treatment (defined as GRA ≥ 1). Mirabegron was intended being given for at least 12 weeks. Adverse events (AEs) and reasons for discontinuing mirabegron were recorded between 4 and 12 weeks of following-up. ResultsThe rate of successful mirabegron treatment (GRA ≥ 1) was 70.5%. The proportion of patients with a successful response was significantly higher in men than in women (75.3% vs. 60.5%, p = 0.022). The success rates as well as the percentage of older patients between groups with or without diabetes, hypertension, nocturia, urge incontinence, or prior anticholinergic treatment were not significantly different. Multivariable analysis showed that male sex was a significant independent predictor (p < 0.05) for successful treatment. The overall rate of AEs was 3.8%, including five cases with hypertension (2.1%) and three with severe voiding difficulty (1.3%). A total of 136 patients (58%) were administered mirabegron for more than 12 weeks. The reasons for discontinuing mirabegron included symptom improvement (17%), loss to follow-up (13%), poor treatment efficacy (8%), and side effects (4%). ConclusionsThe success rate of mirabegron treatment for OAB patients was high and the rate of overall AEs was low. Although only 58% patients continued mirabegron at 12 weeks, most patients (17%) discontinued the treatment because of reduction in symptoms. Male sex showed better response to mirabegron treatment.

Estudio observacional retrospectivo multicéntrico de pacientes con vejiga hiperactiva en tratamiento con mirabegrón y oxibutinina en condiciones de práctica clínica habitual

ObjectiveTo evaluate therapeutic persistence, healthcare resources, medical costs and adverse events of oxybutynin and mirabegron treatments in patients with overactive bladder in routine medical practice. Patients and methodsAn observational, retrospective, multicentre study was carried out using the records of patients attended to in 3 different geographic locations (Barcelona, Girona, Asturias). An analysis was made on the 2 study groups (oxybutynin and mirabegron). Follow-up time was one year. Persistence was defined as the time (months), without discontinuation of the initial treatment, or without change of treatment at least 60 days after the initial prescription. Primary endpoints: comorbidity, healthcare resources used, and adverse events. The data was analysed using the SPSSWIN Program, with a significance of P<.05. ResultsOf the total of1,277 patients included in the study, 42.9% were on oxybutynin and 57.1% mirabegron. The mean age was 69.3 years and 53.2% were female. Demographic characteristics and morbidity were similar between the drugs and had a similar persistence (35.0% oxybutynin vs. 32.2% mirabegron, P=.294), although their costs were lower (1,151.2 vs. €1,809.6, P<.001). The biggest differences were observed in the price of medication (279.2 vs. €692.3, P<.001; a variation of: −€413.1); and adverse events (9.7 vs. 4.9%, P<.001). ConclusionsPatients treated with oxybutynin vs. mirabegron for overactive bladder had similar persistence with the treatment, lower healthcare costs, but with higher oxybutynin vs. mirabegron adverse reaction rates.

Comparative assessment of onabotulinumtoxinA and mirabegron for overactive bladder: an indirect treatment comparison

ContextOnabotulinumtoxinA and mirabegron have recently gained marketing authorisation to treat symptoms of overactive bladder (OAB).ObjectiveTo evaluate the relative efficacy of mirabegron and onabotulinumtoxinA in patients with idiopathic OAB.DesignNetwork meta-analysis.Data sourcesA...

The Role of Mirabegron in Overactive Bladder: A Systematic Review and Meta-Analysis

Objective: To present a systematic review assessing the efficacy and safety of mirabegron for overactive bladder (OAB). Materials and Methods: A literature search was performed using the Cochrane Library, MEDLINE, EMBASE and Science Citation Index Expanded. The literature reviewed included meta-analyses, randomized and nonrandomized prospective studies. We utilized mean difference (MD) to measure the mean number of incontinence episodes and the mean number of micturitions, and OAB questionnaire (OAB-q) and odds ratio (OR) to measure adverse events rates. We used the Cochrane Collaboration's Review Manager 5.1 software for statistical analysis. Results: We identified six publications that strictly met our eligibility criteria. Meta-analysis of extractable data showed that mirabegron was more effective than placebo in treating OAB despite different drug dosages in the efficacy end points: mean number of incontinence episodes per 24 h (MD -0.54; 95% CI -0.63, -0.45; p = 0.001), mean number of micturitions per 24 h (MD -0.55; 95% CI -0.63, -0.47; p = 0.001), OAB-q (MD -4.49; 95% CI -6.27, -2.71; p = 0.001) and adverse events (OR 0.99; 95% CI 0.83, 1.19; p = 0.92). When compared to tolterodine, mirabegron was more effective in terms of mean number of incontinence episodes per 24 h (MD -0.25; 95% CI -0.43, -0.06; p = 0.009). However, there were no differences between mirabegron and tolterodine in mean number of micturitions per 24 h (MD -0.17; 95% CI -0.35, 0.01; p = 0.07) and OAB-q (MD -1.09; 95% CI -2.51, 0.33; p = 0.13). Mirabegron also had a lower adverse reaction rate (OR 0.9; 95% CI 0.8, 1.0; p = 0.04). Conclusions: In this diverse population, mirabegron was an effective and safe pharmacologic therapy for OAB.

Pharmacotherapy of overactive bladder in adults: a review of efficacy, tolerability, and quality of life

IntroductionOveractive bladder (OAB) is a prevalent condition that has a significant impact on quality of life. The usual treatment approach is both behavioral and pharmacological. The first-line pharmacological treatment commonly utilizes anticholinergic agents, which may be limited by their tolerability, efficacy, and long-term compliance. Developments in elucidating the pathophysiology of OAB and alternative targets for pharmacological therapy have led to newer agents being developed to manage this condition. These agents include mirabegron and botulinum toxin, which have alternate mechanism of action and avoid the anticholinergic side effects.ObjectivesTo provide an update for clinicians managing OAB with an overview of the existing and newer medical options for OAB, including pharmacology, efficacy, side-effect profile, tolerability, and impact on patient quality of life.MethodsPubMed and Medline were searched for randomized controlled drug trials in adults with OAB, meta-analyses of medical therapy for OAB, and individual drug names, including the keywords efficacy, tolerability, quality of life, and compliance. Nonhuman studies, pediatric trials, and those involving patients with neurogenic bladder dysfunction (with the exception of studies involving botulinum toxin A) were excluded.ResultsThere is level 1, Grade A evidence to support the efficacy of anticholinergic drugs, botulinum toxin, and mirabegron for OAB. Long-term compliance with anticholinergic medications is limited. The mechanism of action, effectiveness, and side effects of these drugs are discussed, and where the data are available compared with other OAB medications.ConclusionMost of the anticholinergic agents have comparative efficacies and core side-effect profiles, with individual variations relating to their muscarinic receptor selectivity, pharmacokinetics, and metabolism. Newer agents, with alternative sites of action, such as mirabegron and botulinum toxin, provide additional treatment options for patients intolerant to or inadequately treated with anticholinergics.

Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability

Mirabegron, the first β3 -adrenoceptor agonist to enter clinical practice, has a different mechanism of action from antimuscarinic agents. This review presents data on the efficacy, safety, and tolerability of mirabegron in studies conducted to date. All clinical data on mirabegron that are currently in the public domain are included, including some in-press manuscripts. In Phase III clinical trials in patients with overactive bladder (OAB), mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating the symptoms of OAB, including micturition frequency, urgency incontinence, and urgency. Significant improvements in micturition frequency, urgency incontinence, and mean volume voided/micturition were seen as early as the first assessment (week 4) for mirabegron 50 and 100 mg, and were maintained throughout treatment. Responder analyses showed a significant improvement with mirabegron 50 and 100 mg in terms of dry rates, ≥50% reduction in mean number of incontinence episodes/24 hr, and the proportion of patients with ≤8 micturitions/24 hr at final visit. The benefit of mirabegron 50 and 100 mg was also evident in patients ≥65 years of age, and in both treatment-naïve patients and those who previously discontinued antimuscarinic therapy. These data therefore demonstrate a clinically meaningful benefit with mirabegron in the objective endpoints of OAB. Assessment of measures of health-related quality of life and treatment satisfaction showed that patients perceived treatment with mirabegron as meaningful. In OAB clinical trials of up to 12 months mirabegron appeared to be well tolerated. The most common adverse events (AEs) observed with mirabegron in clinical trials of up to 12 months were hypertension, nasopharyngitis, and urinary tract infection. The incidence of dry mouth was similar to placebo, and was between three and fivefold less than for tolterodine extended release 4 mg. Since dry mouth is the most bothersome AE associated with antimuscarinic drugs and often a reason for treatment discontinuation, mirabegron may be a valuable treatment option for these patients. In Phase III clinical trials, mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating symptoms of OAB and, at doses of 50 and 100 mg, demonstrated significant improvements versus placebo on key secondary endpoints, as early as the first assessment (week 4), and these were maintained throughout treatment. In OAB clinical trials of up to 12 months, mirabegron appeared to be well tolerated.

Mirabegron for overactive bladder: a novel, first-in-class β3-agonist therapy.

To discuss the pharmacotherapeutic aspects of Mirabegron which is a first-in class novel β3 receptor agonist drug recently approved by the food and drug administration (FDA) for the treatment of overactive bladder (OAB). We conducted a computerized search of the MEDLINE/PUBMED databases with the word Mirabegron, β3 receptor agonist and overactive bladder. Effect of Mirabegron on β3 adrenergic receptor purportedly releases nitric oxide(NO) by an increase in intracellular Ca2+ through accumulation of cyclic adenosine monophosphate (cAMP). Along with NO which relaxes the detrusor muscle, it also releases an urothelial-derived inhibiting factor (UDIF) that inhibits contractions. It increases the bladder capacity by causing bladder relaxation during the storage phase. Mirabegron appears to be a promising treatment in OAB patients by shifting its management from reducing detrusor over-activity to inducing relaxation. Also it lacks the troublesome side effects associated with the standard antimuscarinic management.

Mirabegron for overactive bladder

Mirabegron for overactive bladder

Panel Supports Mirabegron for Overactive Bladder

Panel Supports Mirabegron for Overactive Bladder

683 Randomised, double-blind, active-controlled phase III study to assess the long-term safety and efficacy of mirabegron in overactive bladder (OAB)

683 Randomised, double-blind, active-controlled phase III study to assess the long-term safety and efficacy of mirabegron in overactive bladder (OAB)