Trial reportBritish journal of clinical pharmacology2001
Effects of supratherapeutic doses of ebastine and terfenadine on the QT interval.
Trial report in British journal of clinical pharmacology, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.
- Incidence and risk of QTc interval prolongation among cancer patients treated with vandetanib: a systematic review and meta-analysis.PloS one · 2012Pooled it
- A comparison of ebastine 10 mg fast-dissolving tablet with oral desloratadine and placebo in inhibiting the cutaneous reaction to histamine in healthy adults.Clinical drug investigation · 2007Trial
- Co-administration of ketoconazole with H1-antagonists ebastine and loratadine in healthy subjects: pharmacokinetic and pharmacodynamic effects.British journal of clinical pharmacology · 2005Trial
- Advances in clinical application of HZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024Review
- Efficacy and Safety of Up-dosed Second-generation Antihistamines in Uncontrolled Chronic Spontaneous Urticaria: A Review.The Journal of clinical and aesthetic dermatology · 2023Review
- Virtual screening of DrugBank database for hERG blockers using topological Laplacian-assisted AI models.Computers in biology and medicine · 2023Article
- Ebastine overdose in a child.Clinical case reports · 2017Article
- Cardiovascular safety of antihistamines.Postepy dermatologii i alergologii · 2014Review
- Slow QT interval adaptation to heart rate changes in normal ambulatory subjects.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2011Article
- Ebastine in the light of CONGA recommendations for the development of third-generation antihistamines.Journal of asthma and allergy · 2009Article
- Effects of supratherapeutic doses of ebastine and terfenadine on the QT interval.British journal of clinical pharmacology · 2002Article
- Non-antiarrhythmic drugs prolonging the QT interval: considerable use in seven countries.British journal of clinical pharmacology · 2002Article
- Updosing of Nonsedating Anti-histamines in Recalcitrant Chronic Urticaria.Indian journal of dermatologyReview
- Ebastine in chronic spontaneous urticaria in higher doses.Indian journal of dermatologyArticle
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe objective of this study was to compare the effects of high doses of ebastine with terfenadine and placebo on QTc.
methodsThirty-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.
resultsEbastine 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.
conclusionsEbastine at doses up to five times the recommended therapeutic dose did not cause clinically relevant changes in QTc interval.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.