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01.06.2013 | Commentary

Choice of Baseline in Parallel Thorough QT Studies

verfasst von: Claus Graff

Erschienen in: Drug Safety | Ausgabe 6/2013

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Excerpt

Although the ICH E14 Guidance [1] was adopted in 2005 there is still much debate on the appropriate baseline needed to adjust for the variable nature of the QT interval and its heart rate corrected value (QTc) in the parallel Thorough QT (TQT) study. Numerous reports have documented the influence of circadian rhythm [2], food ingestion [3], sleep [4], and autonomic tone [5] on the QT/QTc interval. In the absence of baseline measurements, these factors can make it difficult to interpret QT effects of the study drug. …

E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Guidance for industry (2005) online. Available from URL: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129335.htm. Accessed 27 Mar 2013.

Smetana P, Batchvarov V, Hnatkova K, et al. Circadian rhythm of the corrected QT interval: impact of different heart rate correction models. Pacing Clin Electrophysiol. 2003;26:383–6.PubMedCrossRef

Taubel J, Wong AH, Naseem A, et al. Shortening of the QT interval after food can be used to demonstrate assay sensitivity in thorough QT studies. J Clin Pharmacol. 2012;52:1558–65.PubMedCrossRef

Browne KF, Prystowsky E, Heger JJ, et al. Prolongation of the Q-T interval in man during sleep. Am J Cardiol. 1983;52:55–9.PubMedCrossRef

Ahnve S, Vallin H. Influence of heart rate and inhibition of autonomic tone on the QT interval. Circulation. 1982;65:435–9.PubMedCrossRef

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Meng Z, Quan H, Fan L, et al. Use of the average baseline versus the time-matched baseline in parallel group thorough QT/QTc studies. J Biopharm Stat. 2010;20:665–82.PubMedCrossRef

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Sun GG, Quan H, kringle R, et al. Comparison of statistical models adjusting for baseline in the analysis of parallel-group thorough QT/QTc studies. J Biopharm Stat. 2012;22:438–62.PubMedCrossRef

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Lu K. An efficient and robust analysis of covariance model for baseline adjustment in parallel-group thorough QT/QTc studies. Statist Med 2012. doi: 10.1002/sim.5614 (Epub ahead of print).

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Nielsen J, Graff C, Hardahl T, et al. Sertindole causes distinct electrocardiographic T-wave morphology changes. Eur Neuropsychopharmacol. 2009;19:702–7.PubMedCrossRef

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E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Guidance for industry. Questions and answers (R1) 2012 (online). Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073161.pdf. Accessed 29 Mar 2013.

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Beasley CM Jr, Benson C, Xia JQ, et al. Systematic decrements in QTc between the first and second day of contiguous daily ECG recordings under controlled conditions. Pacing Clin Electrophysiol. 2011;34:1116–27.PubMedCrossRef

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Hollister AS, Montague TH. Statistical analysis plans for ECG Data: controlling the intrinsic and extrinsic variability in QT data. In: Morganroth J, Gussak I, editors. Cardiac safety of noncardiac drugs. Totowa: Humana Press; 2005. p. 239–57.CrossRef

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Matz J, Graff C, Vainio PJ, et al. Effect of nalmefene 20 and 80 mg on the corrected QT interval and T-wave morphology: a randomized, double-blind, parallel-group, placebo- and moxifloxacin-controlled, single-centre study. Clin Drug Investig. 2011;31:1–13.CrossRef

Titel: Choice of Baseline in Parallel Thorough QT Studies
verfasst von: Claus Graff
Publikationsdatum: 01.06.2013
Verlag: Springer International Publishing AG
Erschienen in: Drug Safety / Ausgabe 6/2013
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-013-0056-4

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Choice of Baseline in Parallel Thorough QT Studies

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