Drugs that prolong QT interval as an unwanted effect: Assessing their likelihood of inducing hazardous cardiac dysrhythmias

Expert Opinion on Pharmacotherapy

Volumn 1, Issue 5, 2000, Pages 947-973

  Cavero, Icilio ^a   Mestre, Michel ^a   Guillon, Jean Michel ^a   Crumb, William ^a  

^a ZENAS TECHNOLOGIES LLC   (United States)

Author keywords

Acquired long QTsyndrome (LQTS); Benefit risk ratio; Cardiac repolarisation; Congenital LQTS; Drugs prolonging QT interval; Electrocardiogram; Measurement of qt interval; Qt interval; Screening tests

Indexed keywords

DRUG;

ANIMAL; CHEMICALLY INDUCED DISORDER; DRUG EFFECT; ELECTROCARDIOGRAPHY; HEART ARRHYTHMIA; HEART FUNCTION TEST; HUMAN; LONG QT SYNDROME; PATHOPHYSIOLOGY; REVIEW;

ANIMALS; ARRHYTHMIA; ELECTROCARDIOGRAPHY; ELECTROPHYSIOLOGIC TECHNIQUES, CARDIAC; HUMANS; LONG QT SYNDROME; PHARMACEUTICAL PREPARATIONS;

EID: 0034231822     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.1.5.947     Document Type: Article

References (88)

1. COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCT: Points to Consider: the assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products. The European Agency for the Evaluation oj'Medicinal Products (1997) CPMP/986/96.
2. Essential document on the necessity of clinical and non-clinical tests, suggested by European regulatory authorities, for determining cardiac safety of non-cardiovascular drugs.
3. FENICHEL RR, KOERNER J: Development of drugs that alter ventricular repolarization. Paper available upon request from: bob@fenichel.net.
4. Excellent review covering the various aspects of cardiac safety determination, from the perspective of scientists working at the PDA.
5. HURST JW: Naming of the waves in the ECG, with a brief account of their genesis. Circulation (1998) 98:1937-1942.
6. Comprehensive electrocardiology: theory and practice in health and disease. MACFARLANE PW, LAWIE TDV (Eds.), Pergamon Press, London, UK (1989).
7. MORGANROTH J: How to obtain and analyze electrocardiograms (ECGs) in clinical trials: focus on issues in measuring and interpreting changes in the QTc interval duration. Ann. Koninras Electrocardiol. (1999) 4:425-433.
8. COPIER X, ILIOU MC, LAVERGNE MC et ah Measurement of QT interval. Cardiac Electrocardiol. Rev. (1997) 3:357-359.
9. COUMEL P, MAISON-BLANCHE P, BADILINI F: Dispersion of ventricular re-polarization: Reality? Illusion? Significance? Circulation (1998) 97:2491-2493.
10. MALIK M: QT dispersion: tune for an obituary. Europ. Heart J. (2000) 21:955-957. '
11. MOSS A: Drugs that prolong the QT interval: regulatory and QT measurement issues from the United States and European perspective. Ann. tfonimws Eleclrocardiol. (1999) 3:255-25.
12. HODGES M: Rate corrections of the QTintervaL Cardiac Electrocardiol. Rev. (1997) 3:360-363.
13. FUNCK-BRENTANO C, JAILLON P: Rate-corrected QT interval: techniques and limitations. Am. J. Cardiol. (1993) 72:17B-23B.
14. Detailed review on the limitations of various algorithms for the correction of QT interval.
15. PUDDU PE, JOUVE R, MARIOTTI S et al.: Evaluation prediction formulas in 881 middle-aged man from seven country study: emphasis on cubic root Fridericia's equation. J Electrocardiol. (1988) 21:219-229.
16. KAXVATAKI M, KASHIMA T, TODA H, TANAKA H: Relation between QT interval and heart rate: applications and limitations of Bazett's formula. J. Electrocardiol. (1984) 17:371-375.
17. SAGIE A, LARSON MG, GOLDBERG RJ, BENGTSON JR, LEVY D: An improved method for adjusting the QT interval for heart rate (the Framingham Heart study). Am. Heart J. (1992) 70:797-801.
18. PRATT CM, RUBERG S, MORGANROTH J et al.: Dose-response relation between terfcnadine (Scldane) and the QTc interval on the scalar electrocardiogram: distinguishing a drug effect from spontaneous variability. Am. Heart J. (1996) 131:472-480.
19. MOLNARJ, ZHANG F, WEISS J, ELHERT FAC, ROSENTHAL JE: Diurnal pattern of QTc interval: how long is prolonged? Possible relation to Orcadian triggers of cardiovascular events. J. Am. Col. Cardiol. (1996) 27:76-83.
20. COUMEL P, MAISON-BLANCHE P: Physiology of QT interval dynamicity. Cardiac Electrophysiol. Rev. (1997) 3:364-367.
21. MAISON-BLANCHE P, COUMEL P: Changes In repolarisation dynamicity and the assessment of arrhythmic risk. PACE (.1997) 20:2614-2624.
22. LANDE G, FUNCK-BRENTANO C, GHADANFAR M, ESCANDE D: Steady-state versus non steady-state QT-RR relationships in 24-hour Holler recordings. PACE (2000) 23:293-302.
23. LANDE G, MAISON-BLANCHE P, FAYN J, GHADANFARM, COUMEL P, FUNCK-BRENTANO C: Dynamic analysis of dofetilide-induced changes in ventricular repolarisation. Clin. Pbarmacol. Tljer. (1998) 64:312-321.
24. AYTEMIR K, MAAROUF N, GALLAGHER ALM, GUAN YAP Y, WAKTARE JEP, MALIK M: Comparison of formulae for heart rate correction of QT interval in exercise electrocardiogram. PACE (.1999) 22:1397-1401.
25. + current acting as pure class in anti-arrythmic agent. J Cardiovasc. Pbarmacol. (1992) 20 (Suppl. 2):S108-113.
26. KATZ A: Selectivity and toxicity of antiarrhythmic drugs: Molecular interactions with ion channels. A m.J. Med. (1998) 104:179-195.
27. TOMASELLI GF, MARBAM E: Electrophysiological remodelling in hypertrophy and heart failure. Cardiovasc. Res. (1992) 42:270-283.
28. FRISHMAN GI, MCDONALD TV: Gene transfer of membrane channel proteins. In: Cardiac Electrophysiology. From Cell to Bedside. Zipes DP, Jalife J (Eds.), Saunders Company, Philadelphia, USA (2000):58-66.
29. NAPOLITANO C, PRIORI SG, SCWARTZ PJ: Torsades de pointes. Mechanisms and management. Dntgs (1991) 47:51-65.
30. STRATMAN HG, KENNEDY HL: Torsades de pointes associated with drugs and toxins: recognition and management. Am. Heart J. (1987) 113:1470-1482.
31. SURAWICZ B: Electrophysiological substrate for torsade de pointes: dispersion of refractoriness or early aftcr-dcpolarisations. J. Am. Coll. Cardiol. (1989) 14:172-184.
32. ACKERMAN MJ, CLAPHAM DE: Ion channels - Basic science and clinical diseases. N. Engl. J. Med. (1997) 336:1575-1586.
33. VISKIN S: Long QT syndromes and torsades de pointes. The toHcef (1999) 354:1625-1633.
34. PRIORI S, BARHAININ J, HAUER RNW et al: Genetic and molecular basis of cardiac arrhythmia. Impact and clinical management. Enrop. Heart]. (1999) 20:174-195.
35. ABBOTT G\V, SESTI F, SPLAWSKII et al.: MiRPl forms IKT potassium channels with HERG and is associated with cardiac arrhythmia. Cell (1999) 97:175-187.
36. SCHWARTZ P: The long QT syndrome. In: Clinical approaches to tachyanhytbmias. Camm J (Ed.), Futura Publishing Company, Inc, Armonk, NY, USA (1997):167-173.
37. Excellent review on all aspects of long QT syndrome.
38. BENNETT BB: Anchors aweigh. Ion channels, cytoskeletal proteins and cellular excitability. Circ. Res. (2000) 86:386-387.
39. RODEN DM: Taking the 'idio' out of 'idiosyncratic': predicting torsades de pointes. Pacing Clin. Electrophysiol. (1998) 21:1029-1034.
40. PRIORI SG, NAPOLITANO C, SCHWARTZ PJ: Low pcnctrancc in the long QT syndrome. Clinical impact. Circulation (1999) 99:529-533.
41. NAPOLITANO C, SCHWARTZ PJ, BROWN AM et al.: Evidence for cardiac ion channel mutation underlying drug-induced QT prolongation and life-threatening arrythmias. J. Cardiovasc. Electrophysiol. (2000) 11:691-696.
42. PRIORI SG: Exploring the hidden danger of non-cardiac drugs. J. Cardiov. Electrophysiol. (1998) 9:1114-1116.
43. ROSES AD: Pharmacogenetics and future drug development and delivery. Lancet (2000) 335:1358-1361.
44. A short, up-to-date review on current issues concerning pharmacogenetics and drug development.
45. G WEI J, JANG IC-H, TAPPER AR et al: KCNE1 polymorphism confers risk of drug-induced long QT syndrome by altering kinetic properties Iks potassium channels. Circulation (1999) 100:M95. Abstract 2612.
46. H WEI J, ABBOTT G\V, SCHWARTZ PJ et al.: Prevalence of KCNE2 (MiRPl) mutations in acquired long QT syndrome. Circulation (1999) 100:1-495. Abstract 2607.
47. THOMAS SHL: Drugs, QT interval abnormalities and ventricular arrhythmias. Adverse Drug React. (1994) 13:77-102.
48. Excellent review on drug classes producing QT prolongation and torsades dépeintes.
49. DE PONTI F, POLUZZI E, MONTANANO N: QT-prolongation by non-cardiac drugs: lessons to be learned from recent experience. Enr.J. Clin.Phannacol. (2000) 56:1-18.
50. VTTOLA J, VUKANOVICJ, RODEN DM: Cisapride induced torsades de pointes. J. Cardiovasc. Electropbysiol. (1998) 9:1109-1113.
51. VAUGHAM WILLIAM EM: Significance of classifying antiarrhylhmic actions since the cardiac arrhythmia suppression trial./ Clin. Pharmacol. (1991) 31:123-135
52. RODEN DM, WOOSLEY RL, PRIMM RK: Incidence and clinical features of the quinldinc associated long QT syndrome: implications for patient care. Am. Heart J. (1986) 111:1088-1093
53. MCCLELLAN KJ, MARKHAM A: Dofetilide: a review of its use in atrial fibrillation and atrial flutter. Drugs (1999) 58:1043-1059
54. HOHNLOSER SH, KLINGENHEBEN T, SINGH BN: Amiodaronc-associated proarrhythmic effects. Ann. Inter. Med. (1994) 121:529-535.
55. HARTLGAN-GO K, BATMAN DN, DALY AK, THOMAS SHL: Stereoselectivc cardiotoxic effects of tcrodiline. Clin. Pharmacol. TJjer. (1996) 60:80-98.
56. ZHANG S, ZHOU Z, GONG Q, MAKELIESKIJC, JANUARY CT: Mechanism of block and identification of the verapamil binding domain to HERG potassium channels. Clin. Kes. (1999) 84:989-998.
57. YAP YG, CAMM AJ: Arrhythmogenic mechanisms of non-sedating antihistamines. din. Exper. Allergy (.1999) 29(Suppl. 3):174-181.
58. WOOSLEY RL: Cardiac actions of antihistamines. Ann. Rev. Pharmacol. Toxicol. (1996) 36:233-252.
59. WOOSLEY RL, CHEN Y, FREIMAN JP, GILLES RA: Mechanism of the cardiotoxic actions of tcrfenadine. JAMA (1993) 269:1532-1536.
60. PRATT CM, MASON J, RUSSELL T, REYNOLD R, AHLBRANDT R: Cardiovascular safety of fexofenadinc. Am.J. Cardiol. (1999) 83:1451-1454
61. PINTO YM, VAN GELDEN 1C, HEERINGA M, CRIJINS: QT lengthening and life-threatening arrhythmias with fexofenadinc. Lancet (.1999) 353:980-981.
62. NIGHINGALE SL: Warning issued on non-sedating antihistamines tcrfenadinc and astemizole. JAMA (1992) 266:705
63. ZHOU Z, VORIPERIAM VR, GONG Q, ZHANG S, JANUARY CT: Block of HERG potassium channels by the antihistamine antemizole and metabolites demethylantemlzole and norantcmizole. J. Cardiovasc. Electropbysiol. (1999) 10:636-643.
64. DUMAINE R, ROY ML, BROWN AM: Blockade of HERG and Kv1.5 by ketoconazole. / Pbarmacol. Exp. Therap. (1998) 286:727-735.
65. NATTEL S, RANGER S, TALAJIC M, LEMERY R, ROY D: Erythromycin-induced long QT syndrome: concordance with quinidinc and underlying cellular physiological mechanisms. Am.J. Med. (1990) 89:235-238.
66. HONIG PG, WOOSLEY RL, ZAMANI K CONNER DP, CANTILENA LR: Changes in the pharmacokinctics and clcctrocardiographic pharmacodynamics of tcrfenadine with concomitant administration of crythromycin. Clin. Pbarmacol. Tber. (1992) 52:231-238.
67. JAILLON P, MORGANROTH J, BRUMPT I, TALBOT G: Overview of electrocardiograph: and cardiovascular safety data for sparfloxacin. Sparfloxacin Safety Group. J. Antimicrob. Chemotber. (1996) 37(Suppl. A):l6l-l67.
68. LATHERS C, LIPKA L: Cardiac arrhythmia, sudden death and psychoactive drugs. J. Clin. Pbarmacol. (1987) 27:1-14.
69. DROLET B, VINCENT F, RAIL J et al.: Thioridazine lengthen repolarisation of cardiac ventricular myocytes by blocking the delayed rectifier potassium current./ Pbarmacol. Exp. Tberap. (1999) 288:1261-1268.
70. WYSONSKY DK, BACSANYI J: Cisapride and fatal arrhytlimia. N. Engl.J. Med. (1996) 335:290-291.
71. DROLET B, KHALIFA M, DALEAU P, HAMELIN BA, TURGEON J: Block of the rapid component of the delayed rectifier potassium current by the prokinctic agent cisapridc underlies lengthening of QT interval. Circulation (1998) 97:204-210.
72. CRUMB W, CAVERO I: QT Interval prolongation by non-cardiovascular drugs: issues and solutions for novel drug development. f>57T(1999) 2:270-280.
73. A recent review on the various issues concerning the determination of cardiac safety of new drugs.
74. POURR1AS B, PORSOLT RD, LACROIX P: QT prolongation by non-cardiovascular drugs: a proposed assessment strategy. Dmg Develop. Kes. (1999) 47:55-62.
75. CRUMB JW, CAVERO I: Perspectives on the potential of non-cardiovascular drugs to adversely alter cardiac rcpolarisation. Eitr. Pharmaceut. Contractor (2000) 7:63-72.
76. DA VIS AS: The pre-clinical assessment of QT interval prolongation: a comparison of in vitro and in vivo methods. Hum. Exp. Toxicol. (1998) 17:677-688
77. + channels. Cir. Res. (1998) 82:386-395.
78. JOSE DE ABACO F, GARCIA RODRIGUEZ LA: Risk of ventricular arrhythmia associated with non-sedating antmistainine drugs. Br. J. Pharmaacol. (1999) 47:307-313.
79. PRATT CM, HERTZ RP, ELLIS BE, CROWELL SP, LOUV W, MOVE L: Risk of developing life-threatening ventricular arrhythmia associated with tcrfcnadincng comparison with over-the-counter antihistamines, ibuprofen and clemastine. Am. J. Cardiol. (1994) 73:346-352.
80. CAVERO I, MESTRE M, GUILLON JM, HEUILLET E, ROACH AG: Prcclinical in vitro cardiac electrophysiology: a method of predicting arrhythmogcnic potential of antihistamines in humans. Dmg Safety (.1999) 21(Suppl. 1):19-31. -
81. SPENCE S, SOPER K, MO C-M, COLEMAN J: The heart rate-corrected QT interval of conscious beagle dogs: a formula based on analysis of covariance. Toxicol. Sei. (1998) 45:247-258.
82. VOS AM, VERDUYN SC, GORGELSAP, LIPCSEI GC, WELLENS HJ: Reproducible induction of early afterdcpolarisation and torsades de pointes arrhythmias by d-sotalol and pacing in dogs with chronic atriovcntricular blocks. Circulation (1995) 91:864-872.
83. SOSUNOV E, GAINNULIN RZ, DANILO P, Jr. etal.: Electrophysiological effects of LU111995 on canine hearts: in vivo and in vitro studies. J Pharmacol. Exp. Ther. (1999) 290:146-152.
84. ECKART L, HAVERKAMP W, BORGREFFE M, BREITHARDT G: Experimental models of torsades de pointes. Cardiovase. Res. (1998) 39:178-193.
85. CHUANG-STEIN C: The role and analysis of benefit and risk in the development of new drugs. In: The benefit/ risk ratio. A handbook for the rational use of potentially hazardous drugs. Korting HC, Schäfer-Korting M (Eds.). CRH Press, NY, USA (1999):1-10.
86. This contribution is included in a book entirely dedicated to benefit risk issues.
87. MARK DB: Fundamental of economic analysis. Am. Heart J. (1998) 137:538-540.
88. This contribution is included in a thick supplement of Am. Heart J. dedicated to 'Economics and cost-effectiveness in evaluating the value of cardiovascular therapies'.