Comparing methods of measurement for detecting drug-induced changes in the QT interval: Implications for thoroughly conducted ECG studies

Annals of Noninvasive Electrocardiology

Volumn 9, Issue 2, 2004, Pages 166-174

  Azie, Nkechi E ^a   Adams, Gregory ^a   Darpo, Borje ^b,c   Francom, Steven F ^a   Polasek, Emery C ^a   Wisser, Joy M ^a   Fleishaker, Joseph C ^a  

^a PFIZER INC   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^c KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

ECG methodology; Ibutilide; QT interval; QT prolongation

Indexed keywords

IBUTILIDE;

ALGORITHM; ANALYTIC METHOD; ARTICLE; CLINICAL ARTICLE; CONFIDENCE INTERVAL; CONTROLLED STUDY; DOSE RESPONSE; ELECTROCARDIOGRAM; HUMAN; INFUSION; INTERMETHOD COMPARISON; NORMAL HUMAN; PRIORITY JOURNAL; QT INTERVAL; REPRODUCIBILITY; SPECTRAL SENSITIVITY; VOLUNTEER;

ADULT; ANTI-ARRHYTHMIA AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; ELECTROCARDIOGRAPHY, AMBULATORY; FEMALE; HEART CONDUCTION SYSTEM; HUMANS; INFUSIONS, INTRAVENOUS; LONG QT SYNDROME; MALE; OBSERVER VARIATION; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SENSITIVITY AND SPECIFICITY; SULFONAMIDES; TIME FACTORS;

EID: 2342604494     PISSN: 1082720X     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1542-474X.2004.92542.x     Document Type: Article

References (30)

1. Darpo B. Spectrum of drugs prolonging the QT interval and the incidence of torsades de pointes. Eur Heart J 2001;3(Suppl. K):K70-K80.
2. Shah RR. The significance of QT interval in drug development. Br J Clin Pharmacol 2002;54:188-202.
3. Food and Drug Administration and Health Canada. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Preliminary Concept paper, November 15, 2002. Available at http//www.fda.gov/cder/workshop.htm#upcoming.
4. Haverkamp W, Breithardt G, Camm AJ, et al. The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs: Clinical and regulatory implications. Report on a policy conference of the European Society of Cardiology. Eur Heart J 2000;21:1216-1231.
5. Committee for Proprietary Medicinal Products (CPMP/986/96). EMEA. Points to Consider: The assessment of the Potential for QT Interval Prolongation by Non-cardiovascular Medicinal Products., December 17, 1997, London.
6. Malik M, Camm AJ. Evaluation of drug-induced QT interval prolongation: Implications for drug approval and labelling. Drug Saf 2001;24:323-351.
7. Morganroth J, Brown AM, Critz S, et al. Variability of the QTc interval: Impact on defining drug effect and low-frequency cardiac event. Am J Cardiol 1993;72:26B-31B.
8. Dota C, Skallefell B, Edvardsson N, et al. Computer-based analysis of dynamic QT changes: Toward high precision and individual rate correction. Ann Noninvas Electrocardiol 2002;7:289-301.
9. Willems JL, Abreu-Lima C, Arnaud P, et al. The diagnostic performance of computer programs for the interpretation of electrocardiograms. N Engl J Med 1991;325:1767-1773.
10. Yang T, Snyders D, Roden DM. Drug block of I(kr): Model systems and relevance to human arrhythmias. J Cardiovasc Pharmacol 2001;38:737-744.
11. Reiffel JA, Blitzer M. The actions of ibutilide and class Ic drugs on the slow sodium channel: New insights regarding individual pharmacologic effects elucidated through combination therapies. J Cardiovasc Pharmacol Ther 2000;5:177-181.
12. Naccarelli GV, Lee KS, Gibson JK, et al. Electrophysiology and pharmacology of ibutilide. Am J Cardiol 1996;78:12-16.
13. Ellenbogen KA, Stambler BS, Wood MA, et al. Efficacy of intravenous ibutilide for rapid termination of atrial fibrillation and atrial flutter: A dose-response study. J Am Coll Cardiol 1996;28:130-136.
14. Morganroth J. Focus on issues in measuring and interpreting changes in the QTc interval duration. Eur Heart J 2001;3 (Suppl. K:):K105-K111.
15. Browne KF, Prystowsky E, Heger JJ, et al. Prolongation of the Q-T interval in man during sleep. Am J Cardiol 1983;52:55-59.
16. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307-310.
17. Bland JM, Altman DG. Comparing methods of measurement: Why plotting difference against standard method is misleading. Lancet 1995;346:1085-1087.
18. Fridericia LS. Die Systolendauer im Elektrokardiogramm bei normalen Menchen und bei Herzkranken. Acta Med Scand 1920;53:469-486.
19. Pratt CM, Ruberg S, Morganroth J, et al. Dose-response relation between terfenadine (Seldane) and the QTc interval on the scalar electrocardiogram: Distinguishing a drug effect from spontaneous variability. Am Heart J 1996;131:472-480.
20. Kautzner J, Yi G, Camm AJ, et al. Short- and long-term reproducibility of QT, QTc, and QT dispersion measurement in healthy subjects. Pacing Clin Electrophysiol 1994;17:928-937.
21. Sarapa N, Morganroth J, Couderc JP, et al. Electrocardiographic identification of drug-induced QT prolongation: Assessment by different recording and measurement methods. Ann Noninvas Electrocardiol 2004;9:48-57.
22. Fleishaker JC, Francom SF, Herman BD, et al. Lack of effect of reboxetine on cardiac repolarization. Clin Pharmacol Ther 2001;70:261-269.
23. Morganroth J, Lyness WH, Perhach JL, et al. Lack of effect of azelastine and ketoconazole coadministration on electrocardiographic parameters in healthy volunteers. J Clin Pharmacol 1997;37:1065-1072.
24. Darpo B, Almgren O, Bergstrand R, et al. Assessment of frequency dependency of the class m effects of almokalant: A study using programmed stimulation and recording of monophasic action potentials and ventricular paced QT intervals. Cardiovasc Drugs Ther 1996;10:539-547.
25. Darpo B, Vallin H, Almgren O, et al. Selective Ik blocker almokalant exhibits class III-specific effects on the repolarization and refractoriness of the human heart: A study of healthy volunteers using right ventricular monophasic action potential recordings. J Cardiovasc Pharmacol 1995;26:530-540.
26. Demolis JL, Charransol A, Funck-Brentano C, et al. Effects of a single oral dose of sparfloxacin on ventricular repolarization in healthy volunteers. Br J Clin Pharmacol 1996;41:499-503.
27. Demolis JL, Kubitza D, Tenneze L, et al. Effect of a single oral dose of moxifloxacin (400 mg and 800 mg) on ventricular repolarization in healthy subjects. Clin Pharmacol Ther 2000;68:658-666.
28. Honig PK, Wortham DC, Zamani K, et al. Terfenadineketoconazole interaction. Pharmacokinetic and electrocardiographic consequences. JAMA 1993;269:1513-1518.
29. Kivisto KT, Lilja JJ, Backman JT, et al. Repeated consumption of grapefruit juice considerably increases plasma concentrations of cisapride. Clin Pharmacol Ther 1999;66:448-453.
30. van Haarst AD, van't Klooster GA, van Gerven JM, et al. The influence of cisapride and clarithromycin on QT intervals in healthy volunteers. Clin Pharmacol Ther 1998;64:542-546.