What question did this study set out to answer?

To characterize the cardiac safety profile of amiselimod compared directly with fingolimod and placebo in healthy individuals.

December 6, 2016British Journal of Clinical PharmacologyOpen Access

Cardiac effects of amiselimod compared with fingolimod and placebo: results of a randomised, parallel‐group, phase I study in healthy subjects

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Authors

THTomohiko HaradaGifu Pharmaceutical University DWDarren WilbrahamEli Lilly (United Kingdom)GBGuillemette de La Borderie

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Implication

Randomized trial demonstrates a more favorable cardiac safety profile for amiselimod than fingolimod in healthy subjects, suggesting reduced bradyarrhythmia risk.

Key Points

To characterize the cardiac safety profile of amiselimod compared directly with fingolimod and placebo in healthy individuals.
Randomized, parallel-group, phase I trial enrolling 81 healthy subjects aged 18–55 years equally assigned to amiselimod 0.4 mg, amiselimod 0.8 mg, placebo, or fingolimod 0.5 mg once daily for 28 days.
Assessed chronotropic, dromotropic, and inotropic effects using intensive Holter electrocardiogram monitoring and echocardiography.
Neither amiselimod dose produced acute negative chronotropic effects on Days 1 and 2, whereas fingolimod induced a nadir mean hourly heart rate decrease on Day 1 (least squares mean difference: -6.49 bpm, 95% CI -8.95 to -4.02 vs. placebo).
The lowest nadir heart rate reductions for amiselimod occurred on Day 14 for 0.4 mg (-4.40 bpm, 95% CI -7.15 to -1.66) and Day 7 for 0.8 mg (-3.85 bpm, 95% CI -6.58 to -1.11) versus placebo.
No clinically significant bradyarrhythmia or functional cardiac abnormalities occurred with amiselimod, whereas one subject receiving fingolimod was withdrawn on Day 1 due to frequent 2:1 atrioventricular blocks.

Cite This Study

Harada et al. (2016) studied this question.

synapsesocial.com/papers/6a7db2c510b6f5f3737d8bb1 https://doi.org/10.1111/bcp.13203

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Implication

Randomized trial demonstrates a more favorable cardiac safety profile for amiselimod than fingolimod in healthy subjects, suggesting reduced bradyarrhythmia risk.

Cardiac effects of amiselimod compared with fingolimod and placebo: results of a randomised, parallel‐group, phase I study in healthy subjects

Discussion

Member takes

Implication

Key Points

Cite This Study

Cardiac effects of amiselimod compared with fingolimod and placebo: results of a randomised, parallel‐group, phase I study in healthy subjects

Discussion

Member takes

Implication

Key Points

Cite This Study

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