FTY720: Placebo-controlled study of the effect on cardiac rate and rhythm in healthy subjects

FTY720: Placebo-controlled study of the effect on cardiac rate and rhythm in healthy subjects
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DOI:
10.1177/0091270006289853
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发表时间:
2006-08-01
影响因子:
2.9
通讯作者:
Bastien, Marie-Claude
Bastien, Marie-Claude
中科院分区:
医学4区
文献类型:
--
作者:
Schmouder, Robert;Serra, Denise;Bastien, Marie-Claude

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The purpose of this double-blind, placebo-controlled study was to measure the effects of FTY720, a novel immunomodulator, on heart rate and rhythm in healthy volunteers. Subjects (n = 66) were randomized to FTY720 1.25 mg or 5 mg or placebo administered once daily for 7 days. Continuous telemetry revealed an acute, dose-dependent decrease in mean heart rate (10-bpm decrease vs placebo) following the first dose of FTY720, with a nadir generally 4 hours postdose. Although a persistent FTY720-related decrease in heart rate was measured from day 2 to day 7, additional doses of FTY720 after day 2 resulted in no further incremental decreases. Mean PR interval increased by approximately 8 to 10 msec in FTY720-treated subjects on day 1. FTY720 did not increase the QRS or QT interval. These results confirm that the first dose of FTY720 has a mild to moderate negative chronotropic effect.