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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
Language English Country Netherlands
Document type Journal Article, Randomized Controlled Trial
Grant support
ISR CZ-110-RG-14
Astellas Pharma Europe
NLK
ProQuest Central
from 1999-01-01 to 1 year ago
Medline Complete (EBSCOhost)
from 2011-03-01 to 1 year ago
Health & Medicine (ProQuest)
from 1999-01-01 to 1 year ago
- MeSH
- Acetanilides adverse effects therapeutic use MeSH
- Adrenergic beta-3 Receptor Agonists adverse effects therapeutic use MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Urinary Bladder, Overactive drug therapy etiology MeSH
- Cardiovascular Diseases chemically induced MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Spinal Cord Injuries complications MeSH
- Prospective Studies MeSH
- Multiple Sclerosis complications MeSH
- Aged MeSH
- Thiazoles adverse effects therapeutic use MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial 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
References provided by Crossref.org
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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 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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