Mirabegron and Anticholinergics in the Treatment of Overactive Bladder Syndrome: A Meta-analysis

Sartori, Leonardo; Nunes, Belina; Farah, Daniela; Oliveira, Letícia Maria de; Takano, Cláudia Cristina; Sartori, Marair Grácio Ferreira; Fonseca, Marcelo Cunio Machado

doi:10.1055/s-0043-1770093

Cited by 6 publications

(3 citation statements)

References 36 publications

(129 reference statements)

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“…The most frequent side effects of mirabegron were high blood pressure, nasopharyngitis and infection of the urinary tract [10]. Compared to treatment with antimuscarinic drugs, side effects are statistically less common [2,31]. The total number of side effects in people taking mirabegron was 17.0%, compared with 21.4% in patients who were treated with anticholinergics [18].…”

Section: Anti-muscarinicsmentioning

confidence: 99%

An examination of Overactive Bladder Syndrome: present comprehension, methods of treatment, and innovative approaches

Kotowicz,

Pabiś,

Podgórski

2024

J Educ Health Sport

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Introduction Overactive bladder syndrome poses a major challenge to healthcare, as an accurate estimate of its prevalence proves elusive due to patients' reluctance to disclose the embarrassing symptoms that accompany the disorder. Symptoms such as frequent urination, nocturia and incontinence are not only distressing but also significantly impair patients' quality of life. Effective diagnosis and treatment require the identification of associated risk factors, and behavioural therapy serves as the basis for implementing lifestyle modifications. This comprehensive study delves into the managing of overactive bladder syndrome, shedding light on recent advances in diagnosis and treatment. In particular, it looks at the integration of minimally invasive techniques and new medications that promise to not only alleviate symptoms, but also significantly improve patients' overall quality of life. Aim of the study This review aims to identify risk factors, symptoms, methods of diagnosis of overactive bladder syndrome and solutions in its treatment process. The main aim is to present treatment methods with the latest developments. Material and method This article presents the current state of knowledge about overactive bladder syndrome in various scientific articles. Publications describing overactive bladder syndrome, its symptoms, impact on life comfort and treatment options, including recent reports in the field, were reviewed using the PubMed platform. The search included the keywords ‘overactive bladder’, ‘urgency urinary incontinence’, ‘anticholinergics’, ‘mirabegron’, ‘nocturia’.

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Section: Anti-muscarinicsmentioning

confidence: 99%

An examination of Overactive Bladder Syndrome: present comprehension, methods of treatment, and innovative approaches

Kotowicz,

Pabiś,

Podgórski

2024

J Educ Health Sport

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“…Mirabegron, as the first β3-AR agonist used in clinical therapeutics, reduces bladder afferent activity to block the episodes of micturition and incontinence. In the management of patients with OABS, mirabegron is being gradually substituted for antimuscarinic agents because of its curative effect similar to that of antimuscarinic medications and fewer treatment-emergent adverse events (TEAEs), especially in elderly men [9]. β3-AR agonists combined with anticholinergics or α1Bs were reported to be more effective than monotherapy due to differences in the mechanism of action between drugs used alone and in combination [10].…”

Section: Introductionmentioning

confidence: 99%

Mirabegron Add-On Tamsulosin for Men with Overactive Bladder Symptoms: A Pooled Analysis of Four Randomized Controlled Trials

Wu,

Li,

Zhou

et al. 2024

Urol Int

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Introduction: Overactive bladder symptoms (OABS) affect patients’ quality of life (QOL) worldwide. This pooled analysis compared the efficacy and safety of mirabegron add-on tamsulosin with those of tamsulosin add-on placebo in OABS treatment. Methods: PubMed, Embase, MEDLINE, and the Cochrane Controlled Trial Register databases were searched for randomized controlled trials (RCTs) examining the efficacy of mirabegron add-on therapy to tamsulosin in the treatment of OABS. Moreover, references from the selected studies were screened. Review Manager 5.4 was used to analyze data. Results: Four RCTs involving 1397 patients with OABS were selected. Of the total, 697 patients receiving mirabegron add-on tamsulosin constituted the experimental group and 700 patients receiving tamsulosin add-on placebo constituted the control group. The efficacy endpoints were as follows: mean number of micturition per day (mean difference [MD] = −0.26, 95% confidence interval [CI] = −0.41 to −0.10, P = 0.0001), urgency episodes per day (MD = −0.67, 95% CI = −1.02 to −0.32, P = 0.0002), urgency urinary incontinence (UUI) episodes per day (MD = −0.42, 95% CI = −0.66 to −0.19, P = 0.0005), mean volume voided/micturition (MD = 10.84, 95% CI = 4.97 to 16.71, P = 0.0003), total International Prostate Symptom Score (IPSS) (MD = −2.01, 95% CI = −4.02 to −0.01, P = 0.05), and IPSS QOL index (MD = −0.65, 95% CI = −0.94 to −0.35, P < 0.0001). Mirabegron therapy add-on therapy to tamsulosin was effective in treating patients with OABS. Moreover, mirabegron might reduce the total IPSS (MD = −2.01, 95% CI = −4.02 to −0.01, P = 0.05). The safety endpoint, treatment-emergent adverse events (odds ratio = 0.94, 95% CI = 0.78 to 1.13, P = 0.49), suggested that although mirabegron was well-tolerated, it possibly increased the post-void residual urine volume (MD = 10.28, 95% CI = 1.82 to 18.75, P = 0.02). Conclusion: Combination therapy using mirabegron and tamsulosin may be effective in treating patients with non-neurogenic OABS in terms of UUI episodes, total IPSS, and IPSS QOL index. However, its effectiveness must be verified by analyzing additional factors for OABS through further RCTs.

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“…According to a Phase III, randomized, multicenter study ( Herschorn et al, 2013 ), mirabegron is an effective treatment option for OAB, with a low incidence of adverse events (AEs). Compared to antimuscarinics, mirabegron demonstrates comparable efficacy; however, it exhibits fewer AEs ( Sartori et al, 2023 ). Hence, mirabegron is being embraced and utilized more extensively in the management of OAB.…”

Section: Introductionmentioning

confidence: 99%

Examining the safety of mirabegron: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database

Wang,

Zhang,

et al. 2024

Front. Pharmacol.

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Background: Mirabegron, the first β-3 adrenergic receptor agonist, received approval from the Food and Drug Administration (FDA) in 2012 for the treatment of overactive bladder (OAB). This pharmacovigilance study investigated the safety profile of mirabegron treatment using the US FDA Adverse Event Reporting System (FAERS) database.Methods: This study employed disproportionality analyses, including the reporting odds ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) algorithm, to quantify signals of adverse events associated with mirabegron.Results: From the first quarter of 2012 to the third quarter of 2023, a comprehensive total of 14,356,234 adverse event (AE) reports were submitted to the FDA Adverse Event Reporting System database. Within this dataset, encompassing 18,763 reports specifically associated with mirabegron, healthcare professionals notably contributed 2,902 of these reports. A total of 80 preferred terms (PTs) of interest were identified using both the ROR and information component algorithms. The most common AEs included blood pressure increased, urinary retention, atrial fibrillation, dry mouth, and tachycardia, which were consistent with the product instructions. Unexpected significant AEs, such as arrhythmia, palpitations, dementia, transient ischemic attack, Parkinson’s disease, anti-neutrophil cytoplasmic antibody positive vasculitis, lip swelling, and swollen tongue, were also identified. The study findings indicated that the majority of onset time occurred within 30 days (n = 358, 55.68%). However, AEs were still possible after 1 year of mirabegron treatment.Conclusion: This study provided valuable evidence for the real-world safety of mirabegron, helping clinical professionals enhance their understanding of mirabegron’s safety in clinical practice. It also contributed valuable evidence for further safety studies on mirabegron.

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Mirabegron and Anticholinergics in the Treatment of Overactive Bladder Syndrome: A Meta-analysis

Cited by 6 publications

References 36 publications

An examination of Overactive Bladder Syndrome: present comprehension, methods of treatment, and innovative approaches

An examination of Overactive Bladder Syndrome: present comprehension, methods of treatment, and innovative approaches

Mirabegron Add-On Tamsulosin for Men with Overactive Bladder Symptoms: A Pooled Analysis of Four Randomized Controlled Trials

Examining the safety of mirabegron: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database

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