B3 agonists or anticholinergics in the treatment of the lower urinary tract dysfunction in patients with multiple sclerosis?—A randomized study

Glykas, Ioannis; Fragkoulis, Ch; Mitsikostas, Dimos D.; Papatsoris, Athanasios; Mitsogiannis, Iraklis; Papadopoulos, Georgios; Skolarikos, Andreas; Gkialas, Ioannis; Ntoumas, Konstantinos; Dellis, Athanasios

doi:10.1007/s00345-020-03555-8

Cited by 9 publications

(10 citation statements)

References 19 publications

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“… 34 , 35 Subsequently, another two studies demonstrated similar efficacy for mirabegron and solifenacin in multiple sclerosis patients. 36 , 37 In contrast to an initially prospective study by Gubbiotti et al that reported improvement in OAB symptoms in patients with Parkinson’s disease, the prospective randomised PaDoMi study did not find any statistical difference between mirabegron and placebo groups in bladder diary–derived variables or quality of life after 12 weeks of treatment. 38 , 39 Solid evidence on mirabegron efficacy in other diseases resulting in NDO is lacking.…”

Section: Mirabegronmentioning

confidence: 69%

Clinical Utility of β3-Adrenoreceptor Agonists for the Treatment of Overactive Bladder: A Review of the Evidence and Current Recommendations

Krhút¹,

Skugarevská²,

Míka³

et al. 2022

RRU

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This nonsystematic review provides a summary of current evidence on the use of β 3 -adrenoreceptor agonists (β 3 -ARAs) for the treatment for lower urinary tract symptoms. Soon after their discovery in 1989, β 3 -ARs were identified as a predominant adrenoreceptor subtype in the human urinary bladder. Although it is widely believed that β 3 -ARAs cause detrusor relaxation, the effect on bladder afferent signaling likely plays an important role in their mechanism of action as well. In 2011 and 2012, mirabegron was approved for clinical use in overactive bladder (OAB) patients. Pooled analysis of data from prospective randomized studies on >60,000 OAB patients showed that when compared to placebo, mirabegron was superior with respect to reducing the frequency, number, and severity of urgency episodes, number of incontinence episodes and increasing dry rate, but not in reduction of nocturia episodes. The only side effect showing significantly higher incidence than placebo was nasopharyngitis. Mirabegron is approved for OAB treatment in all age-groups and in pediatric patients with neurogenic bladder. Vibegron is another β 3 -ARA approved for OAB treatment in the US and Japan. Several large, multicenter, double-blind, randomized trials have documented statistically significant superiority of vibegron over placebo on all efficacy end points. Other β 3 -ARAs are being developed; however, to date none has been introduced to clinical use. All β 3 -ARAs provide efficacy similar to anticholinergics. They have a favorable safety profile and are well tolerated. Due to their different mechanisms of action, combination of β 3 -ARAs with anticholinergic compounds allows for increased efficacy.

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Section: Mirabegronmentioning

confidence: 69%

Clinical Utility of β3-Adrenoreceptor Agonists for the Treatment of Overactive Bladder: A Review of the Evidence and Current Recommendations

Krhút¹,

Skugarevská²,

Míka³

et al. 2022

RRU

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“…We included a total of 6 studies in the review and all of them were published in English as shown in Table 1 . The included studies were conducted in Korea [ 30 ], Greece [ 31 ], Czech Republic [ 32 ], Lebanon [ 33 ], Canada [ 34 ], and India [ 35 ]. Among six included studies, we contacted the corresponding authors of five studies for additional information on the results and received replies for four [ 30 32 34 35 ].…”

Section: Resultsmentioning

confidence: 99%

“…Four agents, namely placebo and anticholinergics (solifenacin, fesoterodine, darifenacin) were used as comparators. The comparisons in four and two studies were mirabegron versus placebos [ 30 32 33 34 ] and mirabegron versus anticholinergics [ 31 35 ], respectively. Follow-up ranged from 6 to 12 weeks.…”

Section: Resultsmentioning

confidence: 99%

Safety and efficacy of beta-3 adrenergic agonists in treating neurogenic lower urinary tract dysfunction: A systematic review and meta-analysis

Elkhashab,

Alqahtani,

Kim

et al. 2024

Investig Clin Urol

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Purpose To evaluate efficacy and safety of beta-3 adrenergic agonists in adults with neurogenic lower urinary tract dysfunction. Materials and Methods According to a protocol (CRD42022350079), we searched multiple data sources for published and unpublished randomized controlled trials (RCTs) up to 2nd August 2022. Two review authors independently screened studies and abstracted data from the included studies. We performed statistical analyses by using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of evidence (CoE). Results We found data to inform two comparisons: beta-3 adrenergic agonists versus placebo (4 RCTs) and anticholinergics (2 RCTs). Only mirabegron was used for intervention in all included studies. Compared to placebo, beta-3 adrenergic agonists may have a clinically unimportant effect on urinary symptoms score (mean difference [MD] -2.50, 95% confidence interval [CI] -4.78 to -0.22; I 2 =92%; 2 RCTs; 192 participants; low CoE) based on minimal clinically important difference of 3. We are very uncertain of the effects of beta-3 adrenergic agonists on quality of life (MD 10.86, 95% CI 1.21 to 20.50; I 2 =41%; 2 RCTs; 98 participants; very low CoE). Beta-3 adrenergic agonists may result in little to no difference in major adverse events (cardiovascular adverse events) (risk ratio 0.57, 95% CI 0.14 to 2.37; I 2 =0%; 4 RCTs; 310 participants; low CoE). Compared to anticholinergics, no study reported urinary symptom scores and quality of life. There were no major adverse events (cardiovascular adverse events) in either study group (1 study; 60 participants; very low CoE). Conclusions Compared to placebo, beta-3 adrenergic agonists may have similar effects on urinary symptom scores and major adverse events. There were uncertainties about their effects on quality of life. Compared to anticholinergics, we are either very uncertain or have no evidence about urinary symptom scores, quality of life, and major adverse events.

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“…As shown in Fig. 1, 23 RCTs were included with a total of 1697 patients [14–36]. In all, 16 studies investigated the efficacy and safety of antimuscarinics.…”

Section: Resultsmentioning

confidence: 99%

“…An RCT performed by Glykas et al. [14] directly compared the efficacy of antimuscarinics (solifenacin or fesoterodine) and mirabegron in patients with multiple sclerosis (MS). Both agents showed improvement after 3 months; however, no statistical difference was noted between the two cohorts.…”

Section: Resultsmentioning

confidence: 99%

Detrusor relaxing agents for neurogenic detrusor overactivity: a systematic review, meta‐analysis and network meta‐analysis

Zhou

Wang

et al. 2023

BJU International

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ObjectiveTo evaluate the evidence regarding the therapeutic benefits and safety of oral detrusor relaxing agents (DRAs) in treating neurogenic detrusor overactivity (NDO).MethodsA comprehensive search was performed on 1 September 2022. Two authors independently reviewed the articles to extract data using a pre‐designed form. The meta‐analysis was performed following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses statement. A common‐effect or random‐effects model was used based on the heterogeneity among studies. Bayesian network meta‐analysis (NMA) was further performed to make indirect comparisons of antimuscarinics and mirabegron.ResultsA total of 23 randomised controlled trials (RCTs) comprising 1697 patients were included in our analysis. Compared to placebo, the clinical benefits of oral DRAs, along with more adverse events (AEs), were demonstrated in the treatment of NDO. In the subgroup analysis, antimuscarinics significantly improved both urodynamic and bladder diary outcomes (including urinary incontinence episodes, urinary frequency, and residual volume), with a higher rate of AEs, such as xerostomia. Mirabegron improved some of the parameters and had fewer bothersome side‐effects in patients with NDO. The NMA showed that none of the antimuscarinics or mirabegron was superior or inferior to the other.ConclusionsDetrusor relaxing agents are associated with improved outcomes in patients with NDO and our analysis has added new evidence regarding antimuscarinics. Evidence concerning mirabegron as first‐line therapy for NDO is still limited. Well‐designed RCTs are still required in this specific population.

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B3 agonists or anticholinergics in the treatment of the lower urinary tract dysfunction in patients with multiple sclerosis?—A randomized study

Cited by 9 publications

References 19 publications

Clinical Utility of β3-Adrenoreceptor Agonists for the Treatment of Overactive Bladder: A Review of the Evidence and Current Recommendations

Clinical Utility of β3-Adrenoreceptor Agonists for the Treatment of Overactive Bladder: A Review of the Evidence and Current Recommendations

Safety and efficacy of beta-3 adrenergic agonists in treating neurogenic lower urinary tract dysfunction: A systematic review and meta-analysis

Detrusor relaxing agents for neurogenic detrusor overactivity: a systematic review, meta‐analysis and network meta‐analysis

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