Department of Clinical Physiology and Nuclear Medicine Kuopio University Hospital University of Eastern Finland Kuopio Finland.
Neuro CenterDepartment of Neurology Kuopio University Hospital University of Eastern Finland Kuopio Finland.
Brain Behav. 2018 Jan 30;8(2):e00925. doi: 10.1002/brb3.925. eCollection 2018 Feb.
Fingolimod is a sphingosine-1-phosphate receptor modulator for the treatment of relapsing-remitting multiple sclerosis (RRMS). Despite an established effect on heart rate, the effect of fingolimod on cardiac repolarization is not completely known.
Twenty-seven patients with RRMS underwent 24-hr ambulatory ECG before fingolimod (baseline), at the day of fingolimod initiation (1D) and after three-month treatment (3M). The mean values of RR-interval as well as QT-interval corrected by Bazzet's (QTcBaz) and Fridericia's (QTcFri) formula were compared between baseline, 1D, and 3M over 24-hr period as well as at daytime and nighttime.
QTcBaz over 24-hr was shorter at 1D (414 ± 20 ms, < .001) and at 3M (414 ± 20 ms, < .001) than at baseline (418 ± 20 ms). In contrast, QTcFri over 24-hr was longer at 1D (410 ± 19 ms, < .001) but similar at 3M (406 ± 19 ms, = .355) compared to baseline (407 ± 19 ms). Daytime QTcBaz was shorter at 1D ( < .001) and at 3M ( = .007), whereas daytime QTcFri was longer at 1D ( < .05) but similar at 3M ( = ns) compared to baseline. During the night, changes were observed neither in QTcBaz nor in QTcFri between baseline, 1D, and 3M.
Changes in cardiac repolarization after fingolimod initiation were mild and occurred at daytime. Ambiguously, QTcBaz demonstrated shortening, whereas QTcFri showed prolongation in cardiac repolarization after fingolimod initiation. The formula applied for QT-interval correction needs to be taken carefully into account as evaluating pharmacovigilance issues related to fingolimod.
芬戈莫德是一种鞘氨醇-1-磷酸受体调节剂，用于治疗复发缓解型多发性硬化症（RRMS）。尽管其对心率有明确的影响，但芬戈莫德对心脏复极的影响尚不完全清楚。
27 例 RRMS 患者在接受芬戈莫德治疗前（基线）、起始日（1D）和治疗 3 个月（3M）时进行 24 小时动态心电图监测。比较 24 小时内、白天和夜间 RR 间期和校正后的 QT 间期（QTcBaz 和 QTcFri 公式）的平均值在基线、1D 和 3M 之间的差异。
24 小时 QTcBaz 在 1D（414±20ms， ＜.001）和 3M（414±20ms， ＜.001）时短于基线（418±20ms）。相比之下，24 小时 QTcFri 在 1D 时较长（410±19ms， ＜.001），但在 3M 时与基线相似（406±19ms， ＝.355）。1D 和 3M 时白天 QTcBaz 短于基线（ ＜.001），而白天 QTcFri 长于基线（ ＜.05）但在 3M 时与基线相似（ ＝ns）。夜间，基线、1D 和 3M 之间 QTcBaz 和 QTcFri 均无变化。
芬戈莫德起始后心脏复极的变化轻微，发生在白天。QTcBaz 表现为缩短，而 QTcFri 表现为延长，提示 QTcBaz 与 QTcFri 可能用于评价与芬戈莫德相关的药物警戒问题。
