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Clinical Trial
. 2001 Aug;52(2):201-4.
doi: 10.1046/j.0306-5251.2001.01345.x.

Effects of supratherapeutic doses of ebastine and terfenadine on the QT interval

M S Gillen  1 , B Miller, P Chaikin, J Morganroth
Affiliations
Clinical Trial

Effects of supratherapeutic doses of ebastine and terfenadine on the QT interval

M S Gillen et al. Br J Clin Pharmacol. 2001 Aug.

Erratum in

  • Br J Clin Pharmacol 2001 Sep;52(3):343

Abstract

Aims: The objective of this study was to compare the effects of high doses of ebastine with terfenadine and placebo on QTc.

Methods: Thirty-two subjects were randomly assigned to four treatments (ebastine 60 mg x day(-1), ebastine 100 mg x day(-1), terfenadine 360 mg x day(-1), placebo) administered for 7 days. Serial ECGs were performed at baseline and day 7 of each period. QT interval was analysed using both Bazett (QTcB) and Fridericia (QTcF) corrections.

Results: Ebastine 60 mg (+ 3.7 ms) did not cause a statistically significant change in QTcB compared with placebo (+ 1.4 ms). The mean QTcB for ebastine 100 mg was increased by + 10.3 ms which was significantly greater than placebo but was significantly less (P < 0.05) than with terfenadine 360 mg (+ 18.0 ms). There were no statistically significant differences in QTcF between ebastine 60 mg (-3.2 ms) or ebastine 100 mg (1.5 ms) and placebo (-2.1 ms); although terfenadine caused a 14.1 ms increase which was significantly different from the other three treatments. The increase in QTcB with ebastine most likely resulted from overcorrection of the small drug-induced increase in heart rate.

Conclusions: Ebastine at doses up to five times the recommended therapeutic dose did not cause clinically relevant changes in QTc interval.

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References

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