Trial reportClinical drug investigation2012
Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study.
Trial report in Clinical drug investigation, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00419783 (A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects), which is not on this map. Cited by 9 papers.
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.
A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects
Who cites it
9 citing papers in PubMed.
- Evaluation of the single-dose pharmacokinetics of bilastine in subjects with various degrees of renal insufficiency.Clinical drug investigation · 2013Trial
- Trial
- The role and choice criteria of antihistamines in allergy management - expert opinion.Postepy dermatologii i alergologii · 2016Article
- Treatment of allergic rhinitis and urticaria: a review of the newest antihistamine drug bilastine.Therapeutics and clinical risk management · 2016Review
- Pro-arrhythmic potential of oral antihistamines (H1): combining adverse event reports with drug utilization data across Europe.PloS one · 2015Article
- Bilastine: new insight into antihistamine treatment.Clinical and molecular allergy : CMA · 2015Article
- Cardiovascular safety of antihistamines.Postepy dermatologii i alergologii · 2014Review
- Critical appraisal of bilastine for the treatment of allergic rhinoconjunctivitis and urticaria.Therapeutics and clinical risk management · 2013Article
- Bilastine: in allergic rhinitis and urticaria.Drugs · 2012Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesThe International Conference of Harmonisation (ICH) E14 guideline for thorough QT studies requires assessing the propensity of new non-antiarrhythmic drugs to affect cardiac repolarization. The present study investigates whether a composite ECG measure of T-wave morphology (Morphology Combination Score [MCS]) can be used together with the heart rate corrected QT interval (QTc) in a fully ICH E14-compliant thorough QT study to exclude clinically relevant repolarization effects of bilastine, a novel antihistamine.
methodsThirty participants in this crossover study were randomly assigned to receive placebo, moxifloxacin 400 mg, bilastine at therapeutic and supratherapeutic doses (20 and 100 mg) and bilastine 20 mg co-administered with ketoconazole 400 mg. Resting ECGs recorded at 12 nominal time points before and after treatments were used to determine Fridericia corrected QTc (QTcF) and MCS from the T-wave characteristics: asymmetry, flatness and notching.
resultsThere were no effects of bilastine monotherapy (20 and 100 mg) on MCS or QTcF at those study times where the bilastine plasma concentrations were highest. MCS changes for bilastine monotherapy did not exceed the normal intrasubject variance of T-wave shapes for triplicate ECG recordings. Maximum QTcF prolongation for bilastine monotherapy was 5 ms or less: 3.8 ms (90% CI 0.3, 7.3 ms) for bilastine 20 mg and 5.0 ms (90% CI 2.0, 8.0 ms) for bilastine 100 mg. There were no indications of bilastine inducing larger repolarization effects on T-wave morphology as compared with the QTcF interval, as evidenced by the similarity of z-score equivalents for placebo-corrected changes in MCS and QTcF values.
conclusionThis study shows that bilastine, at therapeutic and supratherapeutic dosages, does not induce any effects on T-wave morphology or QTcF. These results confirm the absence of an effect for bilastine on cardiac repolarization.
Indexed as
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Registered trials
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