ArticleBritish journal of clinical pharmacology2014
Are women more susceptible than men to drug-induced QT prolongation? Concentration-QTc modelling in a phase 1 study with oral rac-sotalol.
Article in British journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.
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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
31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.
- A large genome-wide association study of QT interval length utilizing electronic health records.Genetics · 2022Pooled it
- Extracorporeal treatment for poisoning to beta-adrenergic antagonists: systematic review and recommendations from the EXTRIP workgroup.Critical care (London, England) · 2021Pooled it
- Inter-study variability of preclinical in vivo safety studies and translational exposure-QTc relationships--a PKPD meta-analysis.British journal of pharmacology · 2015Pooled it
- A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fenebrutinib and Effect on the QT/QTc Interval in Healthy Participants.Clinical and translational science · 2026Trial
- Trial
- Concentration-QT analysis of the randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects.Journal of pharmacokinetics and pharmacodynamics · 2016Trial
- Beyond pooled analysis: sex-specific cardiovascular adverse event reporting signals with antiarrhythmic drugs in FAERS.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Risk of arrhythmia following ankylosing spondylitis, 2012-2023: a nationwide cohort study.Clinical rheumatology · 2026Article
- Sex-specific virtual population for the prediction and assessment of arrhythmia risk.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- Can in silico models predict drug-induced cardiac risk in vulnerable populations?Toxicology reports · 2026Article
- Sex-based differences in the NRF2 oxidative stress response: Implications for precision therapeutics.Redox biology · 2026Review
- Fast and accurate prediction of drug induced proarrhythmic risk with sex specific cardiac emulators.NPJ digital medicine · 2024Article
- Sex-related differences in incidence, phenotype and risk of sudden cardiac death in inherited arrhythmia syndromes.Frontiers in cardiovascular medicine · 2022Review
- Polygenic risk scores: An overview from bench to bedside for personalised medicine.Frontiers in genetics · 2022Review
- Article
- Sex-Specific Classification of Drug-Induced Torsade de Pointes Susceptibility Using Cardiac Simulations and Machine Learning.Clinical pharmacology and therapeutics · 2021Article
- Sotalol does not interfere with the antielectroshock action of selected second-generation antiepileptic drugs in mice.Pharmacological reports : PR · 2021Article
- Mechanisms of artemether toxicity on single cardiomyocytes and protective effect of nanoencapsulation.British journal of pharmacology · 2020Article
- Potential strategy for assessing QT/QTc interval for drugs that produce rapid changes in heart rate: Electrocardiographic assessment of the effects of intravenous remimazolam on cardiac repolarization.British journal of clinical pharmacology · 2020Article
- Chloroquine or hydroxychloroquine for COVID-19: why might they be hazardous?Lancet (London, England) · 2020Article
Corrections and comments
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Authors and funding
8 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo study the differences in QTc interval on ECG in response to a single oral dose of rac-sotalol in men and women.
methodsContinuous 12-lead ECGs were recorded in 28 men and 11 women on a separate baseline day and following a single oral dose of 160 mg rac-sotalol on the following day. ECGs were extracted at prespecified time points and upsampled to 1000 Hz and analyzed manually in a central ECG laboratory on the superimposed median beat. Concentration-QTc analyses were performed using a linear mixed effects model.
resultsRac-sotalol produced a significant reduction in heart rate in men and in women. An individual correction method (QTc I) most effectively removed the heart rate dependency of the QTc interval. Mean QTc I was 10 to 15 ms longer in women at all time points on the baseline day. Rac-sotalol significantly prolonged QTc I in both genders. The largest mean change in QTc I (ΔQTc I) was greater in females (68 ms (95% confidence interval (CI) 59, 76 ms) vs. 27 ms (95% CI 22, 32 ms) in males). Peak rac-sotalol plasma concentration was higher in women than in men (mean Cmax 1.8 μg ml(-1) (range 1.1-2.8) vs. 1.4 μg ml(-1) (range 0.9-1.9), P = 0.0009). The slope of the concentration-ΔQTc I relationship was steeper in women (30 ms per μg ml(-1) vs. 23 ms per μg ml(-1) in men; P = 0.0135).
conclusionsThe study provides evidence for a greater intrinsic sensitivity to rac-sotalol in women than in men for drug-induced delay in cardiac repolarization.
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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.