Paolicelli Damiano, Manni Alessia, Direnzo Vita, D'Onghia Mariangela, Tortorella Carla, Zoccolella Stefano, Trojano Maria
Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.
J Clin Pharmacol. 2015 Oct;55(10):1131-6. doi: 10.1002/jcph.519. Epub 2015 Jun 17.
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.
芬戈莫德是首个被批准用于治疗多发性硬化症(MS)的口服疾病修正疗法。使用芬戈莫德相关的风险包括心血管不良事件(AE)。所有患者均需进行至少6小时的首剂观察(FDO)。我们描述了一组接受芬戈莫德治疗的复发型MS患者的FDO数据和长期心脏耐受性。212例患者开始每日一次服用0.5毫克芬戈莫德。首次给药前,所有受试者均进行了心电图(ECG)检查并由心脏病专家解读。给药后,他们被监测6小时,并每3个月进行一次心脏监测。在该队列中,第6小时心率降低了9.6±8次/分钟(P<0.001)。54人(25.5%)在6小时内出现异常心电图。我们经历了1例(0.22%)有症状的二度房室传导阻滞。平均随访期为1.5±0.7年。在此期间,1例患者出现心房颤动需要治疗。我们还观察到5例血压持续升高的情况。这项上市后研究表明,芬戈莫德耐受性良好,且从长期来看,心脏不良事件通常是自限性的。