Cardiovascular safety of mirabegron in individuals treated for spinal cord injury- or multiple sclerosis-induced neurogenic detrusor overactivity

Krhút, Jan; Wohlfahrt, Peter; Pudich, Jiří; Kufová, Eliška; Borovička, Vladimír; Bilkova, Karolina; Sýkora, Radek; Mokriš, Jan; Cífková, Renata; Zachoval, Roman; Zvara, Peter

doi:10.1007/s11255-020-02774-7

Cited by 7 publications

(5 citation statements)

References 25 publications

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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%

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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“…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%

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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“…Based on ndings from clinical studies, the predominant cardiovascular AEs linked to mirabegron include hypertension, tachycardia, palpitations, and atrial brillation [18][19][20][21]. Approximately 9-10% of patients undergoing mirabegron treatment may experience hypertension [22]. Furthermore, there have been reports of an increase in the QTc interval [23].…”

Section: Discussionmentioning

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

Preprint

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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 FAERS 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 (IC) 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 one 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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“…Based on findings from clinical studies, the predominant cardiovascular AEs linked to mirabegron include hypertension, tachycardia, palpitations, and atrial fibrillation ( Nitti et al, 2013a ; Batista et al, 2015 ; Rosa et al, 2016 ; Chan et al, 2022 ). Approximately 9%–10% of patients undergoing mirabegron treatment may experience hypertension ( Krhut et al, 2021 ). Furthermore, there have been reports of an increase in the QTc interval ( Balachandran and Duckett, 2015 ).…”

Section: Discussionmentioning

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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Cardiovascular safety of mirabegron in individuals treated for spinal cord injury- or multiple sclerosis-induced neurogenic detrusor overactivity

Cited by 7 publications

References 25 publications

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

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

Examining the Safety of Mirabegron: An Analysis of Real-World Pharmacovigilance Data from the US FDA Adverse Event Reporting System (FAERS) Database

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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