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Volumn 28, Issue 11, 2005, Pages 1009-1028

Drugs, QTc interval prolongation and final ICH E14 guideline: An important milestone with challenges ahead

Author keywords

[No Author keywords available]

Indexed keywords

ALFUZOSIN; CETIRIZINE; CISAPRIDE; FENTANYL; GONADORELIN ANTAGONIST; KETOCONAZOLE; MEXILETINE; MOXIFLOXACIN; NEUROLEPTIC AGENT; OCTREOTIDE; OXYTOCIN; PLACEBO; POTASSIUM CHANNEL HERG; QUINIDINE; SILDENAFIL; SOTALOL; SOTAZIDE; TADALAFIL; TERFENADINE; THIAZIDE DIURETIC AGENT; UNCLASSIFIED DRUG; VARDENAFIL; VASOPRESSIN;

EID: 26944438354     PISSN: 01145916     EISSN: 01145916     Source Type: Journal    
DOI: 10.2165/00002018-200528110-00003     Document Type: Review
Times cited : (114)

References (51)
  • 1
    • 0036039326 scopus 로고    scopus 로고
    • The significance of QT interval in drug development
    • Shah RR. The significance of QT interval in drug development. Br J Clin Pharmacol 2002; 54: 188-202
    • (2002) Br J Clin Pharmacol , vol.54 , pp. 188-202
    • Shah, R.R.1
  • 2
    • 0031786767 scopus 로고    scopus 로고
    • Exploring the hidden danger of noncardiac drugs
    • Priori SG. Exploring the hidden danger of noncardiac drugs. J Cardiovasc Electrophysiol 1998; 9: 1114-6
    • (1998) J Cardiovasc Electrophysiol , vol.9 , pp. 1114-1116
    • Priori, S.G.1
  • 3
    • 14644420246 scopus 로고    scopus 로고
    • Drugs, QT interval prolongation and ICH E14: The need to get it right
    • Shah RR. Drugs, QT interval prolongation and ICH E14: the need to get it right. Drug Saf 2005; 28: 115-25
    • (2005) Drug Saf , vol.28 , pp. 115-125
    • Shah, R.R.1
  • 9
    • 0023898168 scopus 로고
    • Torsade de pointes in a patient receiving intravenous vasopressin
    • Mauro VF, Bingle JF, Ginn SM, et al. Torsade de pointes in a patient receiving intravenous vasopressin. Crit Care Med 1988; 16: 200-1
    • (1988) Crit Care Med , vol.16 , pp. 200-201
    • Mauro, V.F.1    Bingle, J.F.2    Ginn, S.M.3
  • 10
    • 4744346626 scopus 로고    scopus 로고
    • QT interval prolongation after oxytocin bolus during surgical induced abortion
    • Charbit B, Funck-Brentano C, Samain E, et al. QT interval prolongation after oxytocin bolus during surgical induced abortion. Clin Pharmacol Ther 2004; 76: 359-64
    • (2004) Clin Pharmacol Ther , vol.76 , pp. 359-364
    • Charbit, B.1    Funck-Brentano, C.2    Samain, E.3
  • 11
    • 0034113020 scopus 로고    scopus 로고
    • The effect of acute hyperglycaemia on QTc duration in healthy man
    • Marfella R, Nappo F, De Angelis L, et al. The effect of acute hyperglycaemia on QTc duration in healthy man. Diabetologia 2000; 43: 571-5
    • (2000) Diabetologia , vol.43 , pp. 571-575
    • Marfella, R.1    Nappo, F.2    De Angelis, L.3
  • 12
    • 0032012483 scopus 로고    scopus 로고
    • Ventricular tachycardia after oxytocin injection in patients with prolonged Q-T interval syndrome: Report of two cases
    • Liou SC, Chen C, Wong SY, et al. Ventricular tachycardia after oxytocin injection in patients with prolonged Q-T interval syndrome: report of two cases. Acta Anaesthesiol Sin 1998; 36: 49-52
    • (1998) Acta Anaesthesiol Sin , vol.36 , pp. 49-52
    • Liou, S.C.1    Chen, C.2    Wong, S.Y.3
  • 13
    • 23644446140 scopus 로고    scopus 로고
    • The combined use of ibutilide as an active control with intensive electrocardiographic sampling and signal averaging as a sensitive method to assess the effects of tadalafil on the human QT interval
    • Beasley CM, Mitchell MI, Dmitrienko AA, et al. The combined use of ibutilide as an active control with intensive electrocardiographic sampling and signal averaging as a sensitive method to assess the effects of tadalafil on the human QT interval. J Am Coll Cardiol 2005; 46: 678-87
    • (2005) J Am Coll Cardiol , vol.46 , pp. 678-687
    • Beasley, C.M.1    Mitchell, M.I.2    Dmitrienko, A.A.3
  • 14
    • 26944447370 scopus 로고    scopus 로고
    • FDA Cardiovascular and Renal Advisory Committee (29 May)
    • Food and Drug Administration. FDA Cardiovascular and Renal Advisory Committee (29 May 2003). Levitra briefing document [online]. Available from URL: http://www.fda.gov/ohrms/dockets/ac/03/briefing/3956B1_05_Bayer-Levitra.pdf [Accessed 2005 Aug 8]
    • (2003) Levitra Briefing Document [Online]
  • 15
    • 22444444118 scopus 로고    scopus 로고
    • Drugs effects on ventricular repolarization: A critical evaluation of the strengths and weaknesses of current methodologies and regulatory practices
    • Bass AS, Tomaselli G, Bullingham R, et al. Drugs effects on ventricular repolarization: a critical evaluation of the strengths and weaknesses of current methodologies and regulatory practices. J Pharmacol Toxicol Methods 2005; 52: 12-21
    • (2005) J Pharmacol Toxicol Methods , vol.52 , pp. 12-21
    • Bass, A.S.1    Tomaselli, G.2    Bullingham, R.3
  • 16
    • 0021352634 scopus 로고
    • Sotalol, hypokalaemia, syncope, and torsade de pointes
    • McKibbin JK, Pocock WA, Barlow JB, et al. Sotalol, hypokalaemia, syncope, and torsade de pointes. Br Heart J 1984; 2: 157-62
    • (1984) Br Heart J , vol.2 , pp. 157-162
    • McKibbin, J.K.1    Pocock, W.A.2    Barlow, J.B.3
  • 17
    • 21744454338 scopus 로고    scopus 로고
    • The use of electrocardiograms in clinical trials: A public discussion of the proposed ICH E14 regulatory guidance
    • Cavero I, Crumb W. The use of electrocardiograms in clinical trials: a public discussion of the proposed ICH E14 regulatory guidance. Expert Opin Drug Saf 2005; 4: 795-9
    • (2005) Expert Opin Drug Saf , vol.4 , pp. 795-799
    • Cavero, I.1    Crumb, W.2
  • 18
    • 0344492207 scopus 로고    scopus 로고
    • Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: Evidence for a provisional safety margin in drug development
    • Redfern WS, Carlsson L, Davis AS, et al. Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development. Cardiovasc Res 2003; 58: 32-45
    • (2003) Cardiovasc Res , vol.58 , pp. 32-45
    • Redfern, W.S.1    Carlsson, L.2    Davis, A.S.3
  • 19
    • 7544236303 scopus 로고    scopus 로고
    • A mechanistic approach to assess the proarrhythmic risk of QT-prolonging drugs in preclinical pharmacologic studies
    • Shryock JC, Song Y, Wu L, et al. A mechanistic approach to assess the proarrhythmic risk of QT-prolonging drugs in preclinical pharmacologic studies. J Electrocardiol 2004; 37 Suppl.: 34-9
    • (2004) J Electrocardiol , vol.37 , Issue.SUPPL. , pp. 34-39
    • Shryock, J.C.1    Song, Y.2    Wu, L.3
  • 20
    • 7544220656 scopus 로고    scopus 로고
    • Preclinical strategies to assess QT liability and torsadogenic potential of new drugs: The role of experimental models
    • Joshi A, Dimino T, Vohra Y, et al. Preclinical strategies to assess QT liability and torsadogenic potential of new drugs: the role of experimental models. J Electrocardiol 2004; 37 Suppl.: 7-14
    • (2004) J Electrocardiol , vol.37 , Issue.SUPPL. , pp. 7-14
    • Joshi, A.1    Dimino, T.2    Vohra, Y.3
  • 21
    • 3042528658 scopus 로고    scopus 로고
    • Mechanisms of arsenic-induced prolongation of cardiac repolarization
    • Ficker E, Kuryshev YA, Dennis AT, et al. Mechanisms of arsenic-induced prolongation of cardiac repolarization. Mol Pharmacol 2004; 66: 33-44
    • (2004) Mol Pharmacol , vol.66 , pp. 33-44
    • Ficker, E.1    Kuryshev, Y.A.2    Dennis, A.T.3
  • 22
    • 19944429871 scopus 로고    scopus 로고
    • Pentamidine-induced long QT syndrome and block of hERG trafficking
    • Kuryshev YA, Ficker E, Wang L, et al. Pentamidine-induced long QT syndrome and block of hERG trafficking. J Pharmacol Exp Ther 2005; 312: 316-23
    • (2005) J Pharmacol Exp Ther , vol.312 , pp. 316-323
    • Kuryshev, Y.A.1    Ficker, E.2    Wang, L.3
  • 23
    • 22444445634 scopus 로고    scopus 로고
    • HERG-Lite: A novel comprehensive high-throughput screen for drug-induced hERG risk
    • Wible BA, Hawryluk P, Ficker E, et al. HERG-Lite: a novel comprehensive high-throughput screen for drug-induced hERG risk. J Pharmacol Toxicol Methods 2005; 52: 136-45
    • (2005) J Pharmacol Toxicol Methods , vol.52 , pp. 136-145
    • Wible, B.A.1    Hawryluk, P.2    Ficker, E.3
  • 24
    • 13544275836 scopus 로고    scopus 로고
    • Genetic susceptibility to acquired long QT syndrome: Pharmacologic challenge in first-degree relatives
    • Kannankeril PJ, Roden DM, Norris KJ, et al. Genetic susceptibility to acquired long QT syndrome: pharmacologic challenge in first-degree relatives. Heart Rhythm 2005; 2: 134-40
    • (2005) Heart Rhythm , vol.2 , pp. 134-140
    • Kannankeril, P.J.1    Roden, D.M.2    Norris, K.J.3
  • 25
    • 0003485638 scopus 로고    scopus 로고
    • Psychopharmacological Advisory Committee [online]. Rockville (MD): Food and Drug Administration, Jul 19
    • Pfizer Inc. Briefing document for Zeldox capsules. Psychopharmacological Advisory Committee [online]. Rockville (MD): Food and Drug Administration, 2000 Jul 19. Available from URL: http://www.fda.gov/ohrms/dockets/ac/00/backgrd/ 3619b1a.pdf [Accessed 2005 Sep 2]
    • (2000) Briefing Document for Zeldox Capsules
  • 26
    • 0035857764 scopus 로고    scopus 로고
    • Drug-induced QT prolongation in women during the menstrual cycle
    • Rodriguez I, Kilborn MJ, Liu XK, et al. Drug-induced QT prolongation in women during the menstrual cycle. JAMA 2001; 285: 1322-6
    • (2001) JAMA , vol.285 , pp. 1322-1326
    • Rodriguez, I.1    Kilborn, M.J.2    Liu, X.K.3
  • 27
    • 0034014806 scopus 로고    scopus 로고
    • Greater quinidine-induced QTc interval prolongation in women
    • Benton RE, Sale M, Flockhart D, et al. Greater quinidine-induced QTc interval prolongation in women. Clin Pharmacol Ther 2000; 67: 413-8
    • (2000) Clin Pharmacol Ther , vol.67 , pp. 413-418
    • Benton, R.E.1    Sale, M.2    Flockhart, D.3
  • 28
    • 1842855333 scopus 로고    scopus 로고
    • Sex differences in ventricular repolarization: From cardiac electrophysiology to torsades de pointes
    • Abi-Gerges N, Philp K, Pollard C, et al. Sex differences in ventricular repolarization: from cardiac electrophysiology to torsades de pointes. Fundam Clin Pharmacol 2004; 18: 139-51
    • (2004) Fundam Clin Pharmacol , vol.18 , pp. 139-151
    • Abi-Gerges, N.1    Philp, K.2    Pollard, C.3
  • 29
    • 26944445676 scopus 로고    scopus 로고
    • Recent advances in understanding sex differences in cardiac repolarization
    • Jun 24, [Epub ahead of print]
    • James AF, Cho SC, Hancox JC. Recent advances in understanding sex differences in cardiac repolarization. Prog Biophys Mol Biol 2005 Jun 24, [Epub ahead of print]
    • (2005) Prog Biophys Mol Biol
    • James, A.F.1    Cho, S.C.2    Hancox, J.C.3
  • 30
    • 15544365994 scopus 로고    scopus 로고
    • Gender differences in autonomic modulation of ventricular repolarization in humans
    • Nakagawa M, Ooie T, Ou B, et al. Gender differences in autonomic modulation of ventricular repolarization in humans. J Cardiovasc Electrophysiol 2005; 16: 278-84
    • (2005) J Cardiovasc Electrophysiol , vol.16 , pp. 278-284
    • Nakagawa, M.1    Ooie, T.2    Ou, B.3
  • 31
    • 0034774699 scopus 로고    scopus 로고
    • Ethnic differences in electrocardiographic intervals and axes
    • Mansi IA, Nash IS. Ethnic differences in electrocardiographic intervals and axes. J Electrocardiol 2001; 34: 303-7
    • (2001) J Electrocardiol , vol.34 , pp. 303-307
    • Mansi, I.A.1    Nash, I.S.2
  • 32
    • 0345690174 scopus 로고    scopus 로고
    • Ethnic differences in cardiac potassium channel variants: Implications for genetic susceptibility to sudden cardiac death and genetic testing for congenital long QT syndrome
    • Ackerman MJ, Tester DJ, Jones GS, et al. Ethnic differences in cardiac potassium channel variants: implications for genetic susceptibility to sudden cardiac death and genetic testing for congenital long QT syndrome. Mayo Clin Proc 2003; 78: 1479-87
    • (2003) Mayo Clin Proc , vol.78 , pp. 1479-1487
    • Ackerman, M.J.1    Tester, D.J.2    Jones, G.S.3
  • 33
    • 7744243863 scopus 로고    scopus 로고
    • Spectrum and prevalence of cardiac sodium channel variants among black, white, Asian, and Hispanic individuals: Implications for arrhythmogenic susceptibility and Brugada/long QT syndrome genetic testing
    • Ackerman MJ, Splawski I, Makielski JC, et al. Spectrum and prevalence of cardiac sodium channel variants among black, white, Asian, and Hispanic individuals: implications for arrhythmogenic susceptibility and Brugada/long QT syndrome genetic testing. Heart Rhythm 2004; 1: 600-7
    • (2004) Heart Rhythm , vol.1 , pp. 600-607
    • Ackerman, M.J.1    Splawski, I.2    Makielski, J.C.3
  • 34
    • 10744223189 scopus 로고    scopus 로고
    • Electrocardiographic identification of drug-induced QT prolongation: Assessment by different recording and measurement methods
    • Sarapa N, Morganroth J, Couderc JP, et al. Electrocardiographic identification of drug-induced QT prolongation: assessment by different recording and measurement methods. Ann Noninvasive Electrocardiol 2004; 9: 48-57
    • (2004) Ann Noninvasive Electrocardiol , vol.9 , pp. 48-57
    • Sarapa, N.1    Morganroth, J.2    Couderc, J.P.3
  • 35
    • 0032519806 scopus 로고    scopus 로고
    • Agreement and reproducibility of automatic versus manual measurement of QT interval and QT dispersion
    • Savelieva I, Yi G, Guo X, et al. Agreement and reproducibility of automatic versus manual measurement of QT interval and QT dispersion. Am J Cardiol 1998; 81: 471-7
    • (1998) Am J Cardiol , vol.81 , pp. 471-477
    • Savelieva, I.1    Yi, G.2    Guo, X.3
  • 36
    • 2342604494 scopus 로고    scopus 로고
    • Comparing methods of measurement for detecting drug-induced changes in the QT interval: Implications for thoroughly conducted ECG studies
    • Azie NE, Adam G, Darpo B, et al. Comparing methods of measurement for detecting drug-induced changes in the QT interval: implications for thoroughly conducted ECG studies. Ann Noninvasive Electrocardiol 2004; 9: 166-74
    • (2004) Ann Noninvasive Electrocardiol , vol.9 , pp. 166-174
    • Azie, N.E.1    Adam, G.2    Darpo, B.3
  • 37
    • 0036185306 scopus 로고    scopus 로고
    • The imprecision in heart rate correction may lead to artificial observations of drug induced QT interval changes
    • Malik M. The imprecision in heart rate correction may lead to artificial observations of drug induced QT interval changes. PACE 2002; 25: 209-16
    • (2002) PACE , vol.25 , pp. 209-216
    • Malik, M.1
  • 38
    • 0036181222 scopus 로고    scopus 로고
    • Relation between QT and RR intervals is highly individual among healthy subjects: Implications for heart rate correction of the QT interval
    • Malik M, Farbom P, Batchvarov V, et al. Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval. Heart 2002; 87: 220-8
    • (2002) Heart , vol.87 , pp. 220-228
    • Malik, M.1    Farbom, P.2    Batchvarov, V.3
  • 39
    • 0036086224 scopus 로고    scopus 로고
    • QT-RR relationship in healthy subjects exhibits substantial intersubject variability and high intrasubject stability
    • Batchvarov VN, Ghuran A, Smetana P, et al. QT-RR relationship in healthy subjects exhibits substantial intersubject variability and high intrasubject stability. Am J Physiol 2002; 282: H2356-63
    • (2002) Am J Physiol , vol.282
    • Batchvarov, V.N.1    Ghuran, A.2    Smetana, P.3
  • 40
    • 11844276000 scopus 로고    scopus 로고
    • Dynamic beat-to-beat modeling of the QT-RR interval relationship: Analysis of QT prolongation during alterations of autonomic state versus human ether a-go-go-related gene inhibition
    • Fossa AA, Wisialowski T, Magnano A, et al. Dynamic beat-to-beat modeling of the QT-RR interval relationship: analysis of QT prolongation during alterations of autonomic state versus human ether a-go-go-related gene inhibition. J Pharmacol Exp Ther 2005; 312: 1-11
    • (2005) J Pharmacol Exp Ther , vol.312 , pp. 1-11
    • Fossa, A.A.1    Wisialowski, T.2    Magnano, A.3
  • 41
    • 23844475352 scopus 로고    scopus 로고
    • Investigating drug-induced QT and QTc prolongation in the clinic: A review of statistical design and analysis considerations
    • Patterson SD, on behalf of Pharmaceutical Research and Manufacturers of America QT Statistics Expert Team. Investigating drug-induced QT and QTc prolongation in the clinic: a review of statistical design and analysis considerations. Drug Inf J 2005; 39: 243-66
    • (2005) Drug Inf J , vol.39 , pp. 243-266
    • Patterson, S.D.1
  • 42
    • 0036234833 scopus 로고    scopus 로고
    • Towards a drug concentration effect relationship for QT prolongation and torsades de pointes
    • Webster R, Leishman D, Walker D. Towards a drug concentration effect relationship for QT prolongation and torsades de pointes. Curr Opin Drug Discov Devel 2002; 5: 116-26
    • (2002) Curr Opin Drug Discov Devel , vol.5 , pp. 116-126
    • Webster, R.1    Leishman, D.2    Walker, D.3
  • 43
    • 0034801446 scopus 로고    scopus 로고
    • Native and cloned ion channels from human heart: Laboratory models for evaluating the cardiac safety of new drugs
    • Cavero I, Crumb W. Native and cloned ion channels from human heart: laboratory models for evaluating the cardiac safety of new drugs. Eur Heart J 2001; 3 Suppl. K: K53-63
    • (2001) Eur Heart J , vol.3 , Issue.SUPPL. K
    • Cavero, I.1    Crumb, W.2
  • 44
    • 23144435360 scopus 로고    scopus 로고
    • Clinical characteristics and treatment of short QT syndrome
    • Wolpert C, Schimpf R, Veltmann C, et al. Clinical characteristics and treatment of short QT syndrome. Expert Rev Cardiovasc Ther 2005; 3: 611-7
    • (2005) Expert Rev Cardiovasc Ther , vol.3 , pp. 611-617
    • Wolpert, C.1    Schimpf, R.2    Veltmann, C.3
  • 45
    • 24344462320 scopus 로고    scopus 로고
    • Cardiac repolarization: The long and short of it
    • Antzelevitch C. Cardiac repolarization: the long and short of it. Europace 2005; 7 Suppl. 2: 3-9
    • (2005) Europace , vol.7 , Issue.2 SUPPL. , pp. 3-9
    • Antzelevitch, C.1
  • 46
    • 0023613650 scopus 로고
    • Comparative efficacy and safety of oral mexiletine and quinidine in benign or potentially lethal ventricular arrhythmias
    • Morganroth J. Comparative efficacy and safety of oral mexiletine and quinidine in benign or potentially lethal ventricular arrhythmias. Am J Cardiol 1987; 60: 1276-81
    • (1987) Am J Cardiol , vol.60 , pp. 1276-1281
    • Morganroth, J.1
  • 47
    • 20144373180 scopus 로고    scopus 로고
    • Discovery of a small molecule activator of the human ether-ago-go-related gene (hERG) cardiac K+ channel
    • Kang J, Chen X-L, Wang H, et al. Discovery of a small molecule activator of the human ether-ago-go-related gene (hERG) cardiac K+ channel. Mol Pharmacol 2005; 67: 827-36
    • (2005) Mol Pharmacol , vol.67 , pp. 827-836
    • Kang, J.1    Chen, X.-L.2    Wang, H.3
  • 48
    • 23944441185 scopus 로고    scopus 로고
    • Novel potent human ether-a-go-go-related gene (hERG) potassium channel enhancers and their in vitro antiarrhythmic activity
    • Zhou J, Augelli-Szafran CE, Bradley JA, et al. Novel potent human ether-a-go-go-related gene (hERG) potassium channel enhancers and their in vitro antiarrhythmic activity. Mol Pharmacol 2005; 68: 876-84
    • (2005) Mol Pharmacol , vol.68 , pp. 876-884
    • Zhou, J.1    Augelli-Szafran, C.E.2    Bradley, J.A.3
  • 49
    • 2542482516 scopus 로고    scopus 로고
    • New preclinical guidelines on drug effects on ventricular repolarization: Safety pharmacology comes of age
    • Kinter LB, Siegl PKS, Bass AS. New preclinical guidelines on drug effects on ventricular repolarization: safety pharmacology comes of age. J Pharmacol Toxicol Methods 2005; 52: 153-8
    • (2005) J Pharmacol Toxicol Methods , vol.52 , pp. 153-158
    • Kinter, L.B.1    Siegl, P.K.S.2    Bass, A.S.3


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