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.
RCT Entities:
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.
Authors: Eathar Razak; Marie Buncová; Vladimir Shusterman; Bruce Winter; Win-Kuang Shen; Michael J Ackerman; Theresa Donovan; Rachel Lampert; Jan Němec Journal: Ann Noninvasive Electrocardiol Date: 2011-04 Impact factor: 1.468
Authors: Rosa M Antonijoan; Consuelo García-Gea; Montserrat Puntes; Marta Valle; Ramon Esbri; Josep Fortea; Manuel J Barbanoj Journal: Clin Drug Investig Date: 2007 Impact factor: 2.859