Long-term cardiac safety and tolerability of fingolimod in multiple sclerosis: A postmarketing study
| Autor: | Damiano Paolicelli, Stefano Zoccolella, Vita Direnzo, Carla Tortorella, Mariangela D'Onghia, Alessia Manni, Maria Trojano |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male Multiple Sclerosis medicine.medical_treatment Blood Pressure Electrocardiography Heart Rate Atrial Fibrillation Heart rate Product Surveillance Postmarketing Humans Medicine Pharmacology (medical) Atrioventricular Block Adverse effect Pharmacology Fingolimod Hydrochloride business.industry Heart Atrial fibrillation Middle Aged medicine.disease Fingolimod Blood pressure Tolerability Anesthesia Cohort Female Cardiac monitoring business Immunosuppressive Agents medicine.drug |
| Zdroj: | The Journal of Clinical Pharmacology. 55:1131-1136 |
| ISSN: | 0091-2700 |
| DOI: | 10.1002/jcph.519 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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