SEATTLE – , according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In addition, the data “provide further evidence that first-dose cardiac events with fingolimod are rare,” regardless of whether the first dose is given in a clinic or a patient’s home, the study researchers said.
Transient heart rate decreases are an anticipated effect of starting fingolimod, and the U.S. prescribing information for the drug requires first-dose observation of heart rate and blood pressure for at least 6 hours. Heart rate and blood pressure may be monitored in a clinic or at home via theprogram.
To examine whether low baseline heart rate is associated with the likelihood of certain cardiac events during the first-dose observation period, John Osborne, MD, of State of the Heart Cardiology in Grapevine, Tex., and colleagues analyzed retrospective, first-dose observation data from Gilenya@Home between October 2014 and July 2017 and from Gilenya Assessment Network clinics between July 2010 and December 2016.
The investigators sought to determine whether baseline heart rate predicts the risk of documented bradycardia, new-onset second-degree atrioventricular block, or ED transfer for additional monitoring. In addition, they examined whether patients with heart rates above a certain threshold may be at risk of first-dose cardiac events.
Dr. Osborne and colleagues reviewed data from 5,572 in-home and 15,025 in-clinic first-dose observation procedures. They classified patients as having marked bradycardia (under 50 beats per minute), mild bradycardia (50-59 bpm), or a normal heart rate (at least 60 bpm) at baseline. During the 20,001 procedures with available data, 182 cardiac events occurred, including 28 instances of documented bradycardia, 13 instances of second-degree atrioventricular block, and 141 instances of ED transfer for extended monitoring; 40 events occurred during at-home monitoring, and 142 events occurred in clinic.
About 87.0% of the cardiac events occurred in patients with a normal baseline heart rate, 11.5% occurred in patients with mild bradycardia, and 1.1% occurred in patients with marked bradycardia. The two cardiac events in patients with marked bradycardia at baseline were ED transfers of patients whose first-dose observations occurred in clinics. “The threshold heart rate above which patients did not experience a cardiac event was 80 bpm, well within the normal range of 60-100 bpm,” the authors said.
“These data suggest that patients with a low baseline heart rate may be at no more risk of cardiac events than patients with a heart rate in the normal range, nor is there a baseline heart rate threshold below which a patient is at greater risk of cardiac events,” Dr. Osborne and colleagues concluded.
Dr. Osborne reporting receiving a consulting fee from Novartis, which markets Gilenya (fingolimod), and his coauthors are employees of Novartis.