ReviewBritish journal of clinical pharmacology2013
Drug-induced QT interval prolongation: does ethnicity of the thorough QT study population matter?
Review in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.
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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.
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Who cites it
35 citing papers in PubMed, 61 citations in OpenAlex.
- Severity of coeliac disease and clinical management study when using a CYP3A4 metabolised medication: a phase I pharmacokinetic study.BMJ open · 2020Trial
- Moxifloxacin-induced QTc interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study.British journal of clinical pharmacology · 2015Trial
- The effects of moxifloxacin on QTc interval in healthy Korean male subjects.Drugs in R&D · 2014Trial
- Thorough QT study of the effect of oral moxifloxacin on QTc interval in the fed and fasted state in healthy Japanese and Caucasian subjects.British journal of clinical pharmacology · 2014Trial
- The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study.Cardiovascular diabetology · 2013Trial
- Cloperastine in paediatric and adult cough management: a historical narrative review.Drugs in context · 2026Review
- Interim efficacy and safety analysis of the regimen containing delamanid in the treatment of multidrug resistant/rifampicin-resistant/extensively drug-resistant tuberculosis: a single-arm, prospective, monocentric, observational study.BMC infectious diseases · 2025Observational
- QT interval prolongation: clinical assessment, risk factors and quantitative pharmacological considerations.Journal of pharmacokinetics and pharmacodynamics · 2025Review
- Torsade de Pointes and QT Prolongation Among Antifungal Triazoles: A Real-World, Retrospective, Observational, Pharmacovigilance Analysis of the FDA Adverse Event Reporting System (FAERS) Database.Cardiovascular toxicology · 2025Observational
- Cardiac Electrophysiological Effects of the Sodium Channel-Blocking Antiepileptic Drugs Lamotrigine and Lacosamide.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Delamanid-containing regimens over 24 weeks for the treatment of multidrug-resistant/rifampicin-resistant tuberculosis: preliminary results from a single center in a multicenter, prospective, observational study.Frontiers in medicine · 2025Article
- Article
- Complete Heart Block Induced Torsades de Pointes.Cureus · 2024Article
- Developing a Model for Quantifying QTc-Prolongation Risk to Enhance Medication Safety Assessment: A Retrospective Analysis.Journal of personalized medicine · 2024Article
- Drug-induced QT prolongation and torsade de pointes: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database.Frontiers in pharmacology · 2023Article
- Common Ancestry-Specific Ion Channel Variants Predispose to Drug-Induced Arrhythmias.Circulation · 2022Article
- Drug-induced torsades de pointes: Disproportionality analysis of the United States Food and Drug Administration adverse event reporting system.Frontiers in cardiovascular medicine · 2022Article
- Genetic and Molecular Aspects of Drug-Induced QT Interval Prolongation.International journal of molecular sciences · 2021Review
- Comparative risk of cardiac arrhythmias associated with acetylcholinesterase inhibitors used in treatment of dementias - A narrative review.Pharmacology research & perspectives · 2020Review
- Limitations of Animal Studies for Predicting Toxicity in Clinical Trials: Part 2: Potential Alternatives to the Use of Animals in Preclinical Trials.JACC. Basic to translational science · 2020Article
Corrections and comments
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Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Inter-ethnic differences in drug responses have been well documented. Drug-induced QT interval prolongation is a major safety concern and therefore, regulatory authorities recommend a clinical thorough QT study (TQT) to investigate new drugs for their QT-prolonging potential. A positive study, determined by breach of a preset regulatory threshold, significantly influences late phase clinical trials by requiring intense ECG monitoring. A few studies that are currently available, although not statistically conclusive at present, question the assumption that ethnicity of the study population may not influence the outcome of a TQT study. Collective consideration of available pharmacogenetic and clinical information suggests that there may be inter-ethnic differences in QT-prolonging effects of drugs and that Caucasians may be more sensitive than other populations. The information also suggest s that (a) these differences may depend on the QT-prolonging potency of the drug and (b) exposure-response (E-R) analysis may be more sensitive than simple changes in QT(c) interval in unmasking this difference. If the QT response in Caucasians is generally found to be more intense than in non-Caucasians, there may be significant regulatory implications for domestic acceptance of data from a TQT study conducted in foreign populations. However, each drug will warrant an individual consideration when extrapolating the results of a TQT study from one ethnic population to another and the ultimate clinical relevance of any difference. Further adequately designed and powered studies, investigating the pharmacologic properties and E-R relationships of additional drugs with different potencies, are needed in Caucasians, Oriental/Asian and African populations before firm conclusions can be drawn.
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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.