ArticleBritish journal of clinical pharmacology2012
Comparison of the effects of levofloxacin on QT/QTc interval assessed in both healthy Japanese and Caucasian subjects (pages.
Article in British journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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
11 citing papers in PubMed.
- 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
- Randomized, Controlled, Thorough QT/QTc Study Shows Absence of QT Prolongation with Luseogliflozin in Healthy Japanese Subjects.PloS one · 2015Trial
- 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 Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan.Yonago acta medica · 2022Article
- Analysis of Respiratory Fluoroquinolones and the Risk of Sudden Cardiac Death Among Patients Receiving Hemodialysis.JAMA cardiology · 2022Article
- Time of the Day and Magnitude of the Effect of a Drug on the QTc Interval.CPT: pharmacometrics & systems pharmacology · 2017Article
- Levofloxacin-Induced QTc Prolongation Depends on the Time of Drug Administration.CPT: pharmacometrics & systems pharmacology · 2016Article
- Pharmacogenetics of Drug-Induced QT Interval Prolongation: An Update.Drug safety · 2015Review
- Are women more susceptible than men to drug-induced QT prolongation? Concentration-QTc modelling in a phase 1 study with oral rac-sotalol.British journal of clinical pharmacology · 2014Article
- Drug-induced QT interval prolongation: does ethnicity of the thorough QT study population matter?British journal of clinical pharmacology · 2013Review
- Cardiac safety, drug-induced QT prolongation and torsade de pointes (TdP).British journal of clinical pharmacology · 2012Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThere is no consensus as to what extent the results of thorough QT interval/corrected QT interval (QT/QTc) studies need to be bridged.
methodsThe results of two studies using levofloxacin in Japanese and Caucasian subjects were compared in a post hoc analysis to investigate the similarity of dose–effect responses.
resultsConcentration–response analysis based on the change of QT interval corrected using Fridericia's formula (QTcF) from time-matched placebo was planned and performed in the combined data sets. At the geometric maximum mean concentration for the two doses in the Caucasian study, a predicted effect on QTcF comparable to the effects observed was found. For the Japanese study, the predicted effect was lower, but the difference was not statistically significant.
conclusionsNo statistically significant differences in QTc-prolonging effect between Japanese and Caucasian subjects were observed following levofloxacin dosing. However, a trend suggests that Caucasian subjects may be more sensitive. Age and sex did not have an impact.
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