期刊
JOURNAL OF CLINICAL PHARMACOLOGY
卷 49, 期 11, 页码 1353-1362出版社
WILEY
DOI: 10.1177/0091270009339189
关键词
Liraglutide; GLP-1; QTc interval; drug safety
资金
- Novo Nordisk
The objective of this study was to establish effects of liraglutide on the QTc interval. In this randomized, placebocontrolled, double-blind crossover study, 51 healthy participants were administered placebo, 0.6, 1.2, and 1.8 mg liraglutide once daily for 7 days each. Electro-cardiograms were recorded periodically over 24 hours at the end of placebo and highest dosing periods. Four different models for QT correction were used: QTci, as the primary endpoint, and QTciL, QTcF, and QTcB as secondary endpoints. The upper bound of the 1-sided 95% confidence interval for time-matched, baseline-corrected, placebo-subtracted QTc intervals was <10 ms for all 4 correction methods. Moxifloxacin (400 mg) increased QTc intervals by 10.6 to 12.3 ms at 2 hours. There was no concentration-exposure dependency on QTc interval changes by liraglutide and no QTc thresholds above 500 ms or QTc increases >60 ms. The authors conclude that liraglutide caused no clinically relevant increases in the QTc interval.
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