| Autor: |
Neuenschwander, Fernando C., Gaspar, Daniela B. L., Sato, Henry, Finkelstein, Alessandro, Munhoz, Maria Estela, Okamoto, Ivan H., Azarias, Carlos Eduardo, Gonçalves, Patrícia A., Rosario, Juliana M., Taveira, Thiago S., de Souza, Débora M. |
| Zdroj: |
Arquivos de Neuro-Psiquiatria; Jul2013 Supplement, p16-16, 1p |
| Abstrakt: |
Introduction: Fingolimod (Gilenya - Novartis Pharma) is a sphingosine-1 phosphate receptor modulator, which is effective in the treatment of relapsing-remitting multiple sclerosis (RRMS). Fingolimod treatment initiation generally causes asymptomatic and transient bradycardia and can cause atrioventricular (AV) conduction delays; both are linked to SIPR activation. The onset of the effect is as early as 1 hour post administration, while heart rate and conduction normalized within 24 hours in most cases. Objectives: To report the cardiovascular experience and electrocardiogram (ECG) findings during fingolimod treatment initiation. Methods: Patients from five Brazilian centers were included; they were diagnosed with RRMS and received Fingolimod. Vital signs were observed hourly for 6 hours after the first dose of medication. Twelve-lead ECGs were obtained pre-dose and 6hrs post-dose. Results: A total of 90 patients were included, ages ranging from 21 years to 67 years (mean=39yr). The initial heart rate (HR) varied from 45bpm to 105bpm (mean=median=72bpm). All patients experienced some decrease in HR during observation (mean Hit change after 1st hour: 3.5bpm; 2nd: 5bpm; 3rd: 6.1bpm; 4th: 6.4bpm; 5th: 6bpm). New first-degree AV blocks occurred in 4 patients (4.4%); 1 patient had a previous first-degree AV block One case of 2:1 AV block was reported. There were no occurrences of post-dose Mobitz type II or higher-degree AV blocks. No serious cardiac adverse event was reported. No new prolonged QTc intervals (>500ms) occurred after 6 hours post-dose. Discussion: Fingolimod treatment initiation in this population with RRMS was associated with a transient, mostly asymptomatic, decrease in HR, consistent with the known effects on atrial myocytes. Symptomatic bradycardia and Mobitz type I and 2:1 AV blocks were infrequent and generally did not require specific therapy in patients receiving the approved dose of fingolimod. Fingolimod treatment had no significant effect on QTc intervals. [ABSTRACT FROM AUTHOR] |
| Databáze: |
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