Tuesday, 26 November 2013

Cardiac safety of fingolmod in the real world

Fingolimod has a reasonable cardiac safety profile. in terms of the first-dose effect, in the real world. #MSBlog #MSResearch

"This study, in a large number, of MSers starting fingolimod show that the cardiac events associated with fingolimod are uncommon and relatively benign. These results should reassure MSers considering starting fingolimod and mirror our experience of the drug at the Royal London Hospital. Extra vigilance, however, is required for MSers with  pre-existing cardiac conditions or baseline cardiac findings, and those receiving beta blockers and/or calcium channel blockers. The latter drugs are typically used to treat hypertension."


Epub: Gold et al. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol. 2013 Nov.

Objective: The aim of this study was to evaluate short-term safety and tolerability of fingolimod in a real-world population with relapsing multiple sclerosis, focusing on cardiac safety during treatment initiation. 

Methods: MSers received fingolimod 0.5 mg once daily for four months. MSers excluded from the pivotal studies with certain pre-existing cardiac conditions or baseline cardiac findings, and those receiving beta blockers and/or calcium channel blockers, were eligible. Heart rate and electrical conduction events were monitored using ambulatory electrocardiography for at least 6 h after the first dose. 

Results: Of 2,417 enrolled MSers , 2,282 (94.4 %) completed the study. Fingolimod initiation was associated with a transient, mostly asymptomatic decrease in heart rate. Bradycardia adverse events occurred in 0.6 % of MSers and were more frequent in individuals receiving beta blockers and/or calcium channel blockers (3.3 %) than in other MSer subgroups (0.5-1.4 %); most events were asymptomatic, and all MSers recovered without pharmacological intervention. In the 6 h post-dose, the incidences of Mobitz type I second-degree atrioventricular block and 2:1  atrioventricular blockwere higher in patients with pre-existing cardiac conditions or baseline cardiac findings (4.1 and 2.0 %, respectively) than in those without (0.9 and 0.3 %, respectively); at pre-dose screening, patients with pre-existing cardiac conditions or baseline cardiac findings had the same incidence of Mobitz type I second-degree atrioventricular block (4.1 %) and a slightly lower incidence of 2:1 atrioventricular block (0.7 %) than 6 h post-dose. All recorded conduction abnormalities were asymptomatic. 

Conclusion: This study adds to the evidence showing that cardiac effects during fingolimod initiation remain consistent with those known from previous, controlled studies, even if patients with pre-existing cardiac conditions or baseline cardiac findings are included.

CoI: multiple

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