Cardiovascular safety of mirabegron in individuals treated for spinal cord injury- or multiple sclerosis-induced neurogenic detrusor overactivity.
Acetanilides
/ adverse effects
Adolescent
Adrenergic beta-3 Receptor Agonists
/ adverse effects
Adult
Aged
Cardiovascular Diseases
/ chemically induced
Double-Blind Method
Female
Humans
Male
Middle Aged
Multiple Sclerosis
/ complications
Prospective Studies
Spinal Cord Injuries
/ complications
Thiazoles
/ adverse effects
Urinary Bladder, Overactive
/ drug therapy
Young Adult
Cardiovascular safety
Mirabegron
Multiple sclerosis
Neurogenic detrusor overactivity
Spinal cord injury
Journal
International urology and nephrology
ISSN: 1573-2584
Titre abrégé: Int Urol Nephrol
Pays: Netherlands
ID NLM: 0262521
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
received:
19
10
2020
accepted:
22
12
2020
pubmed:
9
1
2021
medline:
7
10
2021
entrez:
8
1
2021
Statut:
ppublish
Résumé
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. 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. 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%). Our results suggest that mirabegron can be safely used in the treatment of patients with SCI- and MS-induced NDO.
Identifiants
pubmed: 33417146
doi: 10.1007/s11255-020-02774-7
pii: 10.1007/s11255-020-02774-7
doi:
Substances chimiques
Acetanilides
0
Adrenergic beta-3 Receptor Agonists
0
Thiazoles
0
mirabegron
MVR3JL3B2V
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1089-1095Subventions
Organisme : Astellas Pharma Europe
ID : ISR CZ-110-RG-14
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