Choice of baseline in a multiple-dose thorough QT study (TQTS) – effect on analysis of moxifloxacin-induced QTc prolongation

References

• Dessertenne F. Ventricular tachycardia with 2 variable opposing foci. Arch Mal Coeur Vaiss. 1966;59(2):263–272.
   PubMedGoogle Scholar
• Wang SH, Lin CY, Huang TY, Wu WS, Chen CC, Tsai SH. QT interval effects of cisapride in the clinical setting. Int J Cardiol. 2001;80(2–3):179–183.
   Web of Science ®Google Scholar
• Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med. 2004;350(10):1013–1022.
   PubMed Web of Science ®Google Scholar
• Yap YG, Camm AJ. Drug induced QT prolongation and torsades de pointes. Heart 2003;89(11):1363–1372.
   PubMed Web of Science ®Google Scholar
• Roden DM, Anderson ME. The pause that refreshes, or does it? Mechanisms in torsades de pointes. Heart. 2000;84(3):235–237.
   PubMed Web of Science ®Google Scholar
• ICH Topic E 14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. 2005; [Accessed September, 2009] Available from: http://www.emea.europa.eu/pdfs/human/ich/000204en.pdf.
   Google Scholar
• Marfella R, Gualdiero P, Siniscalchi M, et al. Morning blood pressure peak, QT intervals, and sympathetic activity in hypertensive patients. Hypertension. 2003;41(2):237–243.
   PubMed Web of Science ®Google Scholar
• Yee KM, Pringle SD, Struthers AD. Circadian variation in the effects of aldosterone blockade on heart rate variability and QT dispersion in congestive heart failure. J Am Coll Cardiol. 2001;37(7):1800–1807.
   PubMed Web of Science ®Google Scholar
• Molnar J, Ranade V Cvetanovic I, Molnar Z, Somberg JC. Evaluation of a 12-lead digital Holter system for 24-hour QT interval assessment. Cardiology. 2006;106(4):224–232.
   Web of Science ®Google Scholar
• Nagy D, DeMeersman R, Gallagher D, et al. QTc interval (cardiac repolarization): lengthening after meals. Obes Res. 1997;5(6):531–537.
   Google Scholar
• Williams GC, Dunnington KM, Hu MY, et al. The impact of posture on cardiac repolarization: more than heart rate? J Cardiovasc Electrophysiol. 2006;17(4):352–358.
   Web of Science ®Google Scholar
• Health Canada Guidance Document. Guide for the Analysis and Review of QT/QTc Interval Data. [Accessed September 2009] Available from: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/qt_review_examen-eng.pdf.
   Google Scholar
• Bloomfield DM, Kost JT, Ghosh K, et al. The effect of moxifloxacin on QTc and implications for the design of thorough QT studies. Clin Pharmacol Ther 2008;84(4):475–480.
   PubMed Web of Science ®Google Scholar
• Zhang X, Silkey M, Schumacher M, et al. Period correction of the QTc of moxifloxacin with multiple predose baseline ECGs is the least variable of 4 methods tested. J Clin Pharmacol 2009;49(5):534–539.
   Web of Science ®Google Scholar
• Badilini F, Maison-Blanche P, Childers R, Coumel P. QT interval analysis on ambulatory electrocardiogram recordings: a selective beat averaging approach. Med Biol Eng Comput. 1999;37(1):71–79.
   Web of Science ®Google Scholar
• Kligfield P, Tyl B, Maarek M, Maison-Blanche P. Magnitude, mechanism, and reproducibility of QT interval differences between superimposed global and individual lead ECG complexes. Ann Noninvasive Electrocardiol. 2007;12(2):145–152.
   Web of Science ®Google Scholar
• Fridericia LS. The duration of systole in an electrocardiogram in normal humans and in patients with heart disease. 1920. Ann Noninvasive Electrocardiol. 2003;8(4):343–351.
   PubMed Web of Science ®Google Scholar
• Malik M, Farbom P, Batchvarov V, Hnatkova K, Camm AJ. Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval. Heart. 2002;87(3):220–228.
   PubMed Web of Science ®Google Scholar
• Malik M, Hnatkova K, Batchvarov V, Gang Y, Smetana P, Camm AJ. Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation. Pacing Clin Electrophysiol. 2004;27(12):1659–1669.
   PubMed Web of Science ®Google Scholar
• Couderc JP, Xiaojuan X, Zareba W, Moss AJ. Assessment of the stability of the individual-based correction of QT interval for heart rate. Ann Noninvasive Electrocardiol. 2005;10(1):25–34.
   PubMed Web of Science ®Google Scholar
• Garnett CE, Beasley N, Bhattaram VA, et al. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol. 2008;48(1):13–18.
   PubMed Web of Science ®Google Scholar
• E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. Questions and Answers. 2008; [Accessed September 2009] Available at http://www.emea.europa.eu/pdfs/human/ich/31013308en.pdf.
   Google Scholar
• Diedrich A, Jordan J, Shannon JR, Robertson D, Biaggioni I. Modulation of QT interval during autonomic nervous system blockade in humans. Circulation. 2002;106(17):2238–2243.
   Web of Science ®Google Scholar
• Ong JJ, Sarma JS, Venkataraman K, Levin SR, Singh BN. Circadian rhythmicity of heart rate and QTc interval in diabetic autonomic neuropathy: implications for the mechanism of sudden death. Am Heart J. 1993;125(3):744–752.
   Web of Science ®Google Scholar
• Journal article on the Internet: The European Agency for the Evaluation of Medicinal Products (EMEA), committee for Proprietary Medicinal Products (CPMP), Efficacy Working Party (EXP). Points to consider on adjustment for baseline covariates.[Accessed 2009]. http://www.emea.europa.eu/pdfs/human/ewp/286399en.pdf
   Google Scholar
• Senn SJ. Cross-over trials in clinical research. 2nd ed. Chichester: Willey; 2002.
   Google Scholar
• Extramiana F, Maison-Blanche P, Haggui A, Badilini F, Beaufils P, Leenhardt A. Control of rapid heart rate changes for electrocardiographic analysis: implications for thorough QT studies. Clin Cardiol. 2006;29(12):534–539.
   Web of Science ®Google Scholar
• Zhang J, Machado SG. Statistical issues including design and sample size calculation in thorough QT/QTc studies. J Biopharm Stat. 2008;18(3):451–67.
   PubMed Web of Science ®Google Scholar