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Cardiovascular safety of mirabegron in individuals treated for spinal cord injury- or multiple sclerosis-induced neurogenic detrusor overactivity
J. Krhut, P. Wohlfahrt, J. Pudich, E. Kufová, V. Borovička, K. Bílková, R. Sýkora, J. Mokriš, R. Cífková, R. Zachoval, P. Zvara
Jazyk angličtina Země Nizozemsko
Typ dokumentu časopisecké články, randomizované kontrolované studie
Grantová podpora
ISR CZ-110-RG-14
Astellas Pharma Europe
NLK
ProQuest Central
od 1999-01-01 do Před 1 rokem
Medline Complete (EBSCOhost)
od 2011-03-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 1999-01-01 do Před 1 rokem
- MeSH
- acetanilidy škodlivé účinky terapeutické užití MeSH
- agonisté beta-3-adrenergních receptorů škodlivé účinky terapeutické užití MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- hyperaktivní močový měchýř farmakoterapie etiologie MeSH
- kardiovaskulární nemoci chemicky indukované MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- poranění míchy komplikace MeSH
- prospektivní studie MeSH
- roztroušená skleróza komplikace MeSH
- senioři MeSH
- thiazoly škodlivé účinky terapeutické užití MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
PURPOSE: To analyze cardiovascular safety of mirabegron in patients with spinal cord injury (SCI)- and multiple sclerosis (MS)-induced neurogenic detrusor overactivity (NDO) in a prospective, randomized, double-blind, placebo-controlled study. METHODS: Seventy-eight patients were enrolled into the study, and 66 of them were included into the final analysis. In 49 (74.2%), NDO developed due to suprasacral SCI, 17 (25.8%) suffered from NDO due to MS. Eleven patients were previously treated for hypertension and one for arrhythmia. All study participants received placebo for 2 weeks run-in period. Subsequently, eligible subjects were randomized for 4 weeks of active treatment with mirabegron 50 mg once daily (Group A; n = 32) or placebo (Group B; n = 34). Data from resting electrocardiography (ECG), 24-h ECG and blood pressure monitoring, and echocardiographic examination, were used for cardiovascular safety assessment. All reported variables were evaluated at time of randomization and at the end of the study. Longitudinal changes of variables within the groups and differences between the groups were assessed using nonparametric Kruskal-Wallis test, and p ≤ 0.05 was considered statistically significant. RESULTS: No statistically significant longitudinal changes were found in safety variables, except for prolongation of QT interval in placebo group (p = 0.0328) recorded by resting ECG. No significant difference between the Groups A and B, in any of the variables, was observed. A single cardiovascular study drug-related adverse event was recorded in a patient with cervical SCI (3.13%). CONCLUSIONS: Our results suggest that mirabegron can be safely used in the treatment of patients with SCI- and MS-induced NDO.
Department of Cardiology University Hospital Ostrava Czech Republic
Department of Surgical Studies Medical Faculty Ostrava University Ostrava Czech Republic
Department of Urology Odense University Hospital Odense Denmark
Department of Urology University Hospital Tř 17 listopadu 1790 708 52 Ostrava Czech Republic
Spinal Cord Rehabilitation Unit Rehabilitation Center Kladruby Czech Republic
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- $a Krhut, Jan $u Department of Urology, University Hospital, Tř. 17. listopadu 1790, 708 52, Ostrava, Czech Republic. jan.krhut@fno.cz $u Department of Surgical Studies, Medical Faculty, Ostrava University, Ostrava, Czech Republic. jan.krhut@fno.cz
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- $a Cardiovascular safety of mirabegron in individuals treated for spinal cord injury- or multiple sclerosis-induced neurogenic detrusor overactivity / $c J. Krhut, P. Wohlfahrt, J. Pudich, E. Kufová, V. Borovička, K. Bílková, R. Sýkora, J. Mokriš, R. Cífková, R. Zachoval, P. Zvara
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- $a PURPOSE: To analyze cardiovascular safety of mirabegron in patients with spinal cord injury (SCI)- and multiple sclerosis (MS)-induced neurogenic detrusor overactivity (NDO) in a prospective, randomized, double-blind, placebo-controlled study. METHODS: Seventy-eight patients were enrolled into the study, and 66 of them were included into the final analysis. In 49 (74.2%), NDO developed due to suprasacral SCI, 17 (25.8%) suffered from NDO due to MS. Eleven patients were previously treated for hypertension and one for arrhythmia. All study participants received placebo for 2 weeks run-in period. Subsequently, eligible subjects were randomized for 4 weeks of active treatment with mirabegron 50 mg once daily (Group A; n = 32) or placebo (Group B; n = 34). Data from resting electrocardiography (ECG), 24-h ECG and blood pressure monitoring, and echocardiographic examination, were used for cardiovascular safety assessment. All reported variables were evaluated at time of randomization and at the end of the study. Longitudinal changes of variables within the groups and differences between the groups were assessed using nonparametric Kruskal-Wallis test, and p ≤ 0.05 was considered statistically significant. RESULTS: No statistically significant longitudinal changes were found in safety variables, except for prolongation of QT interval in placebo group (p = 0.0328) recorded by resting ECG. No significant difference between the Groups A and B, in any of the variables, was observed. A single cardiovascular study drug-related adverse event was recorded in a patient with cervical SCI (3.13%). CONCLUSIONS: Our results suggest that mirabegron can be safely used in the treatment of patients with SCI- and MS-induced NDO.
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