title: Long-term cardiac safety and tolerability of fingolimod in multiple sclerosis: A postmarketing study.
abstract: Fingolimod is the first oral disease-modifying therapy approved for multiple sclerosis (MS). The risks associated with the use of fingolimod include cardiovascular adverse events (AEs). First-dose observation (FDO) is required for all patients for at least 6 hours. We describe FDO data and long-term cardiac tolerability in a cohort of fingolimod-treated relapsing MS patients. Two hundred and twelve patients started fingolimod 0.5 mg once daily. Before the first administration, all subjects had an electrocardiogram (ECG) with cardiologist interpretation. Following administration they were monitored for 6 hours and underwent a cardiac monitoring every 3 months. In this cohort, there was a heart rate reduction at the VI hour of 9.6 ± 8 beats per minute (P < .001). Fifty-four individuals (25.5%) presented an abnormal ECG during the 6 hours. We experienced 1 case (0.22%) of symptomatic second-degree atrioventricular block. The mean follow-up period was 1.5 ± 0.7 years. During this period, 1 patient showed atrial fibrillation that needed to be treated. We also observed 5 cases of persistent increase in blood pressure. This postmarketing study shows that fingolimod is well tolerated and tha tcardiologic AEs are generally self-limited in the long term.
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.
authors.forename: Damiano
authors.initials: D
authors.lastname: Paolicelli
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Manni
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.
authors.forename: Vita
authors.initials: V
authors.lastname: Direnzo
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: D'Onghia
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Tortorella
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Zoccolella
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
mesh_terms: D000328:Adult; D001281:Atrial Fibrillation / Q000139:chemically induced; D054537:Atrioventricular Block / Q000139:chemically induced; D001794:Blood Pressure / Q000187:drug effects; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000009:adverse effects* / Q000627:therapeutic use; D006321:Heart / Q000187:drug effects; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy / Q000503:physiopathology*; D011358:Product Surveillance, Postmarketing
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
keywords: cardiac; fingolimod; first-dose observation; long-term safety; multiple sclerosis