Cardiac Safety Profile of the First Dose Observation. Interim Analysis of the Argentinean Registry of Patients Treated with Fingolimod (REAL Study) (P2.076)
2016; Lippincott Williams & Wilkins; Volume: 86; Issue: 16_supplement Linguagem: Inglês
10.1212/wnl.86.16_supplement.p2.076
ISSN1526-632X
AutoresGustavo Seifer, Fernando Cáceres, Marcela Parada Marcilla, Vladimiro Sinay, Miguel Jacobo, Roberto Rey, Maria Luisa Saladino, Andrés Villa, Marcos Burgos, Norma Deri, Rossana Neme, Graciela Arguello De Alday, José-María Blasco, Patricio Labal, Christian Calvo Vildoso, Santiago A. Vétere, Gabriel Volman, Carlos Ballario, Jorge Blanche, Marcelo Matiazzi, Alberto Rodriguez Alfici, Herrera Gustavo, Ramiro Linares, Virginia Parisi, Andrés Barboza, Pedro Nofal, Margarita Moreno, Albornoz Liliana, Gaston Kuperman, Andrés Greco,
Tópico(s)Toxin Mechanisms and Immunotoxins
ResumoObjective: The aim of this interim analysis of the REAL study is to assess the cardiac safety profile during first-dose monitoring period (FDO) of Fingolimod (Gilenya) treatment in Argentina. Background: Fingolimod, an oral sphingosine-1-phosphate-receptor (S1PR) modulator, is approved for relapsing remitting multiple sclerosis (RRMS). The S1PRs are present in cardiac myocytes which explains the potential effects on heart rate. Methods: REAL is a prospective, 2-year, open-label study enrolling 200 patients with RRMS from 25 centers across Argentina. Results: A total of 181 patients were included, 130 females (71.8[percnt]), mean age 42 (19-68 years). No patient had significant cardiac history. In 131 patients baseline mean heart rate (HR) was 73.54 bpm and at the end of the monitoring period was 66.73 (p=0.001), mean decrease of 6.81 bpm. Baseline ECGs were within normal limits in all patients. The nadir of the HR was seen between the 4th a 5th hour. Ten patients reached values of 55 or less bpm and one patient reached 44 bpm. The PR interval did not show relevant differences, basal 146.23ms and at 6 hours was 147.60ms, mean delta of 1.362ms (p=0.415). The QTc intervals during the monitoring period did not show differences between baseline and at 6 hours (373.27ms vs. 379.32ms (p=0.273) for males and 376.26ms vs 381.78ms for females). Five patients required extended monitoring after 6 hours due to prolonged asymptomatic bradycardia and were discharged at 9 hour of observation. None patient developed symptomatic bradycardia. Conclusions: The interim results in this cohort of 181 patients in Argentina demonstrated a very well tolerated cardiac safety profile of the FDO. Sinus bradycardia was the only clinical cardiovascular event observed in 3.7[percnt] of patients and the electrocardiography assessment did not show evidence of atrioventricular conduction disorders (PR and QTc intervals). The study was supported by Novartis Argentina.
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