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Volumn 158, Issue 3, 2009, Pages 317-326

Current challenges in the evaluation of cardiac safety during drug development: Translational medicine meets the Critical Path Initiative

Author keywords

[No Author keywords available]

Indexed keywords

AMIODARONE; ASTEMIZOLE; BIOLOGICAL MARKER; CISAPRIDE; FLOSEQUINAN; GREPAFLOXACIN; PHENOBARBITAL; POTASSIUM CHANNEL HERG; QUETIAPINE; RANOLAZINE; ROFECOXIB; TERFENADINE; TERODILINE; TROPONIN; VALDECOXIB; VERAPAMIL;

EID: 68949149740     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2009.06.007     Document Type: Review
Times cited : (111)

References (50)
  • 1
    • 0035092543 scopus 로고    scopus 로고
    • Evaluation of the characteristics of safety withdrawal of prescription drugs from worldwide pharmaceuticals markets - 1960 to 1999
    • Fung M., Thorton A., Mybeck K., et al. Evaluation of the characteristics of safety withdrawal of prescription drugs from worldwide pharmaceuticals markets - 1960 to 1999. Drug Inf J 35 (2001) 293-317
    • (2001) Drug Inf J , vol.35 , pp. 293-317
    • Fung, M.1    Thorton, A.2    Mybeck, K.3
  • 2
    • 5344219653 scopus 로고    scopus 로고
    • Introduction
    • Talbot J., and Waller P. (Eds), John Wiley and Sons, Ltd., Maiden (MA)
    • Stephens M. Introduction. In: Talbot J., and Waller P. (Eds). Stephens' Detection of New Adverse Drug Reactions. 5th ed. (2004), John Wiley and Sons, Ltd., Maiden (MA) 1-91
    • (2004) Stephens' Detection of New Adverse Drug Reactions. 5th ed. , pp. 1-91
    • Stephens, M.1
  • 4
    • 0000940609 scopus 로고    scopus 로고
    • Withdrawal of troglitazone and cisapride
    • Henney J.E. Withdrawal of troglitazone and cisapride. JAMA 283 (2000) 2228
    • (2000) JAMA , vol.283 , pp. 2228
    • Henney, J.E.1
  • 5
    • 0024321898 scopus 로고
    • Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction
    • The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med 321 (1989) 406-412
    • (1989) N Engl J Med , vol.321 , pp. 406-412
    • The Cardiac Arrhythmia Suppression Trial (CAST) Investigators1
  • 6
    • 0000296591 scopus 로고
    • Effect of flosequinan on survival in chronic heart failure: preliminary results of the PROFILE trial
    • Packer M., Rouleau J., Swedberg K., et al. Effect of flosequinan on survival in chronic heart failure: preliminary results of the PROFILE trial. Circulation 88 Suppl I (1993) I-301
    • (1993) Circulation , vol.88 , Issue.SUPPL. I
    • Packer, M.1    Rouleau, J.2    Swedberg, K.3
  • 8
    • 62749084498 scopus 로고    scopus 로고
    • An uncertain future for cardiovascular drug development?
    • Garber A.M. An uncertain future for cardiovascular drug development?. N Engl J Med 360 (2009) 1169-1171
    • (2009) N Engl J Med , vol.360 , pp. 1169-1171
    • Garber, A.M.1
  • 9
    • 34548127718 scopus 로고    scopus 로고
    • Withdrawal of COX-2 selective inhibitors rofecoxib and valdecoxib: impact on NSAID and gastroprotective drug prescribing and utilization
    • Sun S.X., Lee K.Y., Bertram C.T., et al. Withdrawal of COX-2 selective inhibitors rofecoxib and valdecoxib: impact on NSAID and gastroprotective drug prescribing and utilization. Curr Med Res Opin 23 (2007) 1859-1866
    • (2007) Curr Med Res Opin , vol.23 , pp. 1859-1866
    • Sun, S.X.1    Lee, K.Y.2    Bertram, C.T.3
  • 10
    • 85077298184 scopus 로고    scopus 로고
    • FDA announces plan to halt marketing of terfenadine
    • FDA announces plan to halt marketing of terfenadine. Am J Health Syst Pharm 54 (1997) 342-
    • (1997) Am J Health Syst Pharm , vol.54
  • 11
    • 0005354212 scopus 로고    scopus 로고
    • Withdrawal of terodiline: a tale of two toxicities
    • Mann R., and Andrews E. (Eds), John Wiley and Sons, Ltd., London
    • Shah R. Withdrawal of terodiline: a tale of two toxicities. In: Mann R., and Andrews E. (Eds). Pharmacovigilance (2002), John Wiley and Sons, Ltd., London
    • (2002) Pharmacovigilance
    • Shah, R.1
  • 12
    • 58549101899 scopus 로고    scopus 로고
    • FDA and the critical path to twenty-first-century medicine
    • Pitts P.J. FDA and the critical path to twenty-first-century medicine. J Med Philos 33 (2008) 515-523
    • (2008) J Med Philos , vol.33 , pp. 515-523
    • Pitts, P.J.1
  • 13
    • 0031412855 scopus 로고    scopus 로고
    • Cardiac troponin T is a sensitive, specific biomarker of cardiac injury in laboratory animals
    • O'Brien P.J., Dameron G.W., Beck M.L., et al. Cardiac troponin T is a sensitive, specific biomarker of cardiac injury in laboratory animals. Lab Anim Sci 47 (1997) 486-495
    • (1997) Lab Anim Sci , vol.47 , pp. 486-495
    • O'Brien, P.J.1    Dameron, G.W.2    Beck, M.L.3
  • 14
    • 39749110000 scopus 로고    scopus 로고
    • Cardiac troponin is the most effective translational safety biomarker for myocardial injury in cardiotoxicity
    • O'Brien P.J. Cardiac troponin is the most effective translational safety biomarker for myocardial injury in cardiotoxicity. Toxicology 245 (2008) 206-218
    • (2008) Toxicology , vol.245 , pp. 206-218
    • O'Brien, P.J.1
  • 15
    • 57149119763 scopus 로고    scopus 로고
    • Analytical characteristics of commercial cardiac troponin I and T immunoassays in serum from rats, dogs, and monkeys with induced acute myocardial injury
    • Apple F.S., Murakami M.M., Ler R., et al. Analytical characteristics of commercial cardiac troponin I and T immunoassays in serum from rats, dogs, and monkeys with induced acute myocardial injury. Clin Chem 54 (2008) 1982-1989
    • (2008) Clin Chem , vol.54 , pp. 1982-1989
    • Apple, F.S.1    Murakami, M.M.2    Ler, R.3
  • 16
    • 0035755341 scopus 로고    scopus 로고
    • Elevations in cardiac troponin measurements: false false-positives
    • Jaffe A. Elevations in cardiac troponin measurements: false false-positives. Cardiovasc Toxicol 1 (2001) 87-92
    • (2001) Cardiovasc Toxicol , vol.1 , pp. 87-92
    • Jaffe, A.1
  • 17
    • 1442306232 scopus 로고    scopus 로고
    • Drug-induced prolongation of the QT interval
    • Roden D.M. Drug-induced prolongation of the QT interval. N Engl J Med 350 (2004) 1013-1022
    • (2004) N Engl J Med , vol.350 , pp. 1013-1022
    • Roden, D.M.1
  • 18
    • 0031893970 scopus 로고    scopus 로고
    • Block of the rapid component of the delayed rectifier potassium current by the prokinetic agent cisapride underlies drug-related lengthening of the QT interval
    • Drolet B., Khalifa M., Daleau P., et al. Block of the rapid component of the delayed rectifier potassium current by the prokinetic agent cisapride underlies drug-related lengthening of the QT interval. Circulation 97 (1998) 204-210
    • (1998) Circulation , vol.97 , pp. 204-210
    • Drolet, B.1    Khalifa, M.2    Daleau, P.3
  • 19
    • 0025222965 scopus 로고
    • Torsades de pointes occurring in association with terfenadine use
    • Monahan B.P., Ferguson C.L., Killeavy E.S., et al. Torsades de pointes occurring in association with terfenadine use. JAMA 264 (1990) 2788-2790
    • (1990) JAMA , vol.264 , pp. 2788-2790
    • Monahan, B.P.1    Ferguson, C.L.2    Killeavy, E.S.3
  • 20
    • 35148850168 scopus 로고    scopus 로고
    • Effect of ranolazine, an antianginal agent with novel electrophysiological properties, on the incidence of arrhythmias in patients with non ST-segment elevation acute coronary syndrome: results from the Metabolic Efficiency With Ranolazine for Less Ischemia in Non ST-Elevation Acute Coronary Syndrome Thrombolysis in Myocardial Infarction 36 (MERLIN-TIMI 36) Randomized Controlled Trial
    • Scirica B.M., Morrow D.A., Hod H., et al. Effect of ranolazine, an antianginal agent with novel electrophysiological properties, on the incidence of arrhythmias in patients with non ST-segment elevation acute coronary syndrome: results from the Metabolic Efficiency With Ranolazine for Less Ischemia in Non ST-Elevation Acute Coronary Syndrome Thrombolysis in Myocardial Infarction 36 (MERLIN-TIMI 36) Randomized Controlled Trial. Circulation 116 (2007) 1647-1652
    • (2007) Circulation , vol.116 , pp. 1647-1652
    • Scirica, B.M.1    Morrow, D.A.2    Hod, H.3
  • 21
    • 19444382797 scopus 로고    scopus 로고
    • ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis
    • Cavero I., and Crumb W. ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis. Ex Opin Drug Saf 4 (2005) 509-530
    • (2005) Ex Opin Drug Saf , vol.4 , pp. 509-530
    • Cavero, I.1    Crumb, W.2
  • 22
    • 0030588699 scopus 로고    scopus 로고
    • Sex difference in risk of torsade de pointes with d,l-sotalol
    • Lehmann M.H., Hardy S., Archibald D., et al. Sex difference in risk of torsade de pointes with d,l-sotalol. Circulation 94 (1996) 2535-2541
    • (1996) Circulation , vol.94 , pp. 2535-2541
    • Lehmann, M.H.1    Hardy, S.2    Archibald, D.3
  • 23
    • 48149092512 scopus 로고    scopus 로고
    • Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics
    • Vargas H.M., Bass A.S., Breidenbach A., et al. Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics. J Pharmacol Toxicol Methods 58 (2008) 72-76
    • (2008) J Pharmacol Toxicol Methods , vol.58 , pp. 72-76
    • Vargas, H.M.1    Bass, A.S.2    Breidenbach, A.3
  • 24
    • 21344463329 scopus 로고    scopus 로고
    • Refining detection of drug-induced proarrhythmia: QT interval and TRIaD
    • Shah R.R., and Hondeghem L.M. Refining detection of drug-induced proarrhythmia: QT interval and TRIaD. Heart Rhythm 2 (2005) 758-772
    • (2005) Heart Rhythm , vol.2 , pp. 758-772
    • Shah, R.R.1    Hondeghem, L.M.2
  • 25
    • 27244456179 scopus 로고    scopus 로고
    • International conference on harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice
    • Food and Drug Administration, HHS. International conference on harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice. Fed Regist 70 (2005) 61134-61135
    • (2005) Fed Regist , vol.70 , pp. 61134-61135
    • Food and Drug Administration, HHS,1
  • 26
    • 33745151940 scopus 로고    scopus 로고
    • Relation of QT interval measurements to evolving automated algorithms from different manufacturers of electrocardiographs
    • Kligfield P., Hancock E.W., Helfenbein E.D., et al. Relation of QT interval measurements to evolving automated algorithms from different manufacturers of electrocardiographs. Am J Cardiol 98 (2006) 88-92
    • (2006) Am J Cardiol , vol.98 , pp. 88-92
    • Kligfield, P.1    Hancock, E.W.2    Helfenbein, E.D.3
  • 27
    • 39749173672 scopus 로고    scopus 로고
    • Improving the detection of subtle I(Kr)-inhibition: assessing electrocardiographic abnormalities of repolarization induced by moxifloxacin
    • Couderc J.P., McNitt S., Hyrien O., et al. Improving the detection of subtle I(Kr)-inhibition: assessing electrocardiographic abnormalities of repolarization induced by moxifloxacin. Drug Saf 31 (2008) 249-260
    • (2008) Drug Saf , vol.31 , pp. 249-260
    • Couderc, J.P.1    McNitt, S.2    Hyrien, O.3
  • 28
    • 55649110026 scopus 로고    scopus 로고
    • Investigating the effect of sotalol on the repolarization intervals in healthy young individuals
    • Corrected proof, in press
    • Couderc J-P, Zhou M, Sarapa N, et al. Investigating the effect of sotalol on the repolarization intervals in healthy young individuals. J Electrocardiol [in press], Corrected proof.
    • J Electrocardiol
    • Couderc, J.-P.1    Zhou, M.2    Sarapa, N.3
  • 29
    • 0035043773 scopus 로고    scopus 로고
    • Problems of heart rate correction in assessment of drug-induced QT interval prolongation
    • Malik M. Problems of heart rate correction in assessment of drug-induced QT interval prolongation. J Cardiovasc Electrophysiol 12 (2001) 411-420
    • (2001) J Cardiovasc Electrophysiol , vol.12 , pp. 411-420
    • Malik, M.1
  • 30
    • 11144273910 scopus 로고    scopus 로고
    • Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation
    • Marek M., Hnatkova K., Batchvarov V., et al. Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation. Pacing Clin Electrophysiol 27 (2004) 1659-1669
    • (2004) Pacing Clin Electrophysiol , vol.27 , pp. 1659-1669
    • Marek, M.1    Hnatkova, K.2    Batchvarov, V.3
  • 31
    • 0346732890 scopus 로고    scopus 로고
    • Cases from the Osler Medical Service at Johns Hopkins University
    • Piccini J., and Zaas A. Cases from the Osler Medical Service at Johns Hopkins University. Am J Med 115 (2003) 70-71
    • (2003) Am J Med , vol.115 , pp. 70-71
    • Piccini, J.1    Zaas, A.2
  • 33
    • 34247397075 scopus 로고    scopus 로고
    • Further evidence of inherited long QT syndrome gene mutations in antiarrhythmic drug-associated torsades de pointes
    • Lehtonen A., Fodstad H., Laitinen-Forsblom P., et al. Further evidence of inherited long QT syndrome gene mutations in antiarrhythmic drug-associated torsades de pointes. Heart Rhythm 4 (2007) 603-607
    • (2007) Heart Rhythm , vol.4 , pp. 603-607
    • Lehtonen, A.1    Fodstad, H.2    Laitinen-Forsblom, P.3
  • 34
    • 0037161355 scopus 로고    scopus 로고
    • Allelic variants in long-QT disease genes in patients with drug-associated torsades de pointes
    • Yang P., Kanki H., Drolet B., et al. Allelic variants in long-QT disease genes in patients with drug-associated torsades de pointes. Circulation 105 (2002) 1943-1948
    • (2002) Circulation , vol.105 , pp. 1943-1948
    • Yang, P.1    Kanki, H.2    Drolet, B.3
  • 35
    • 19644399507 scopus 로고    scopus 로고
    • Genomics and drug toxicity
    • Lord P.G., and Papoian T. Genomics and drug toxicity. Science 306 (2004) 575
    • (2004) Science , vol.306 , pp. 575
    • Lord, P.G.1    Papoian, T.2
  • 37
    • 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 76 (2004) 359-364
    • (2004) Clin Pharmacol Ther , vol.76 , pp. 359-364
    • Charbit, B.1    Funck-Brentano, C.2    Samain, E.3
  • 38
    • 18044381359 scopus 로고    scopus 로고
    • Pentamidine reduces hERG expression to prolong the QT interval
    • Cordes J.S., Sun Z., Lloyd D.B., et al. Pentamidine reduces hERG expression to prolong the QT interval. Br J Pharmacol 145 (2005) 15-23
    • (2005) Br J Pharmacol , vol.145 , pp. 15-23
    • Cordes, J.S.1    Sun, Z.2    Lloyd, D.B.3
  • 39
    • 34247327016 scopus 로고    scopus 로고
    • Molecular, biologic, and pharmacokinetic properties of monoclonal antibodies: impact of these parameters on early clinical development
    • Mascelli M.A., Zhou H., Sweet R., et al. Molecular, biologic, and pharmacokinetic properties of monoclonal antibodies: impact of these parameters on early clinical development. J Clin Pharmacol 47 (2007) 553-565
    • (2007) J Clin Pharmacol , vol.47 , pp. 553-565
    • Mascelli, M.A.1    Zhou, H.2    Sweet, R.3
  • 40
    • 34547119058 scopus 로고    scopus 로고
    • TNF-alpha downregulates transient outward potassium current in rat ventricular myocytes through iNOS overexpression and oxidant species generation.
    • Fernández-Velasco M., Ruiz-Hurtado G., Hurtado O., et al. TNF-alpha downregulates transient outward potassium current in rat ventricular myocytes through iNOS overexpression and oxidant species generation. Am J Physiol Heart Circ Physiol 293 (2007) H238-H245
    • (2007) Am J Physiol Heart Circ Physiol , vol.293
    • Fernández-Velasco, M.1    Ruiz-Hurtado, G.2    Hurtado, O.3
  • 41
    • 54349091558 scopus 로고    scopus 로고
    • Safety-related regulatory actions for biologicals approved in the United States and the European Union
    • Giezen T.J., Mantel-Teeuwisse A.K., Straus S.M., et al. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 300 (2008) 1887-1896
    • (2008) JAMA , vol.300 , pp. 1887-1896
    • Giezen, T.J.1    Mantel-Teeuwisse, A.K.2    Straus, S.M.3
  • 42
    • 9644310269 scopus 로고    scopus 로고
    • Inhibition of ErbB2 causes mitochondrial dysfunction in cardiomyocytes: implications for herceptin-induced cardiomyopathy
    • Grazette L.P., Boecker W., Matsui T., et al. Inhibition of ErbB2 causes mitochondrial dysfunction in cardiomyocytes: implications for herceptin-induced cardiomyopathy. J Am Coll Cardiol 44 (2004) 2231-2238
    • (2004) J Am Coll Cardiol , vol.44 , pp. 2231-2238
    • Grazette, L.P.1    Boecker, W.2    Matsui, T.3
  • 43
    • 48149110309 scopus 로고    scopus 로고
    • Dose response effects of sotalol on cardiovascular function in conscious, freely moving cynomolgus monkeys
    • Lynch III J.J., Wilson A.W., Hernandez L.E., et al. Dose response effects of sotalol on cardiovascular function in conscious, freely moving cynomolgus monkeys. Br J Pharmacol 154 (2008) 1439-1445
    • (2008) Br J Pharmacol , vol.154 , pp. 1439-1445
    • Lynch III, J.J.1    Wilson, A.W.2    Hernandez, L.E.3
  • 44
    • 1842472957 scopus 로고    scopus 로고
    • Insights from ambulatory blood pressure monitoring: diagnosis of hypertension and diurnal blood pressure in renal transplant recipients
    • Haydar A.A., Covic A., Jayawardene S., et al. Insights from ambulatory blood pressure monitoring: diagnosis of hypertension and diurnal blood pressure in renal transplant recipients. Transplantation 77 (2004) 849-853
    • (2004) Transplantation , vol.77 , pp. 849-853
    • Haydar, A.A.1    Covic, A.2    Jayawardene, S.3
  • 45
    • 0037722939 scopus 로고    scopus 로고
    • Night-time blood pressure load is associated with higher left ventricular mass index in renal transplant recipients
    • Toprak A., Koc M., Tezcan H., et al. Night-time blood pressure load is associated with higher left ventricular mass index in renal transplant recipients. J Hum Hypertens 17 (2003) 239-244
    • (2003) J Hum Hypertens , vol.17 , pp. 239-244
    • Toprak, A.1    Koc, M.2    Tezcan, H.3
  • 46
    • 36348975228 scopus 로고    scopus 로고
    • Effects of torcetrapib in patients at high risk for coronary events
    • Barter P.J., Caulfield M., Eriksson M., et al. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med 357 (2007) 2109-2122
    • (2007) N Engl J Med , vol.357 , pp. 2109-2122
    • Barter, P.J.1    Caulfield, M.2    Eriksson, M.3
  • 47
    • 0037238861 scopus 로고    scopus 로고
    • Adverse drug event monitoring at the Food and Drug Administration
    • Ahmad S.R. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med 18 (2003) 57-60
    • (2003) J Gen Intern Med , vol.18 , pp. 57-60
    • Ahmad, S.R.1
  • 49
    • 0020448932 scopus 로고
    • Comparison of the effects of propranolol, pindolol, oxprenolol and acebutolol on atrioventricular conduction in unanaesthetized dogs
    • Kantelip J.P., Duchene-Marullaz P., Delaigue-Fabry R., et al. Comparison of the effects of propranolol, pindolol, oxprenolol and acebutolol on atrioventricular conduction in unanaesthetized dogs. Br J Clin Pharmacol 13 Suppl 2 (1982) 159S-166S
    • (1982) Br J Clin Pharmacol , vol.13 , Issue.SUPPL. 2
    • Kantelip, J.P.1    Duchene-Marullaz, P.2    Delaigue-Fabry, R.3
  • 50
    • 0023694743 scopus 로고
    • Safety issues during antihypertensive treatment with angiotensin converting enzyme inhibitors
    • Weber M.A. Safety issues during antihypertensive treatment with angiotensin converting enzyme inhibitors. Am J Med 84 (1988) 16-23
    • (1988) Am J Med , vol.84 , pp. 16-23
    • Weber, M.A.1


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