Cumulative Experience of Azimilide-Associated Torsades de Pointes Ventricular Tachycardia in the 19 Clinical Studies Comprising the Azimilide Database

Journal of the American College of Cardiology

Volumn 48, Issue 3, 2006, Pages 471-477

  Pratt, Craig M ^a   Al Khalidi, Hussein R ^b   Brum, Jose M ^b   Holroyde, Michael J ^b   Schwartz, Peter J ^c   Marcello, Stephen R ^b   Borggrefe, Martin ^d   Dorian, Paul ^e   Camm, A John ^f  

^a HOUSTON METHODIST RESEARCH INSTITUTE   (United States)

^b PROCTER AND GAMBLE PHARMACEUTICALS   (United States)

^c FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^d UNIVERSITY OF HEIDELBERG   (Germany)

^e ST MICHAEL'S HOSPITAL   (Canada)

^f ST GEORGE S HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AZIMILIDE;

ADULT; AGED; ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEFIBRILLATION; DISEASE ASSOCIATION; DOSE RESPONSE; FEMALE; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HEART LEFT VENTRICLE EJECTION FRACTION; HEART RATE; HEART SUPRAVENTRICULAR ARRHYTHMIA; HEART VENTRICLE TACHYCARDIA; HUMAN; INCIDENCE; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; META ANALYSIS; PRIORITY JOURNAL; QT INTERVAL; RISK ASSESSMENT; RISK FACTOR; SYSTEMATIC REVIEW; TORSADE DES POINTES; TREATMENT OUTCOME;

AGED; ANTI-ARRHYTHMIA AGENTS; ARRHYTHMIA; DATABASES, FACTUAL; DOSE-RESPONSE RELATIONSHIP, DRUG; ELECTROCARDIOGRAPHY; FEMALE; HUMANS; IMIDAZOLIDINES; MALE; MIDDLE AGED; PIPERAZINES; TIME FACTORS; TORSADES DE POINTES;

EID: 33746366782     PISSN: 07351097     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacc.2006.04.075     Document Type: Article

References (30)

1. Salata J.J., and Brooks R.R. Pharmacology of azimilide dihydrochloride. (NE-10064). Card Drug Rev 15 (1997) 137-156
2. Connolly S.J., Schnell D.J., Page R.L., et al., Azimilide Supraventricular Arrhythmia Program Investigators. Symptoms at the time of arrhythmia recurrence in patients receiving azimilide for control of atrial fibrillation or flutter. results from randomized trials. for the. Am Heart J 146 (2003) 489-493
3. Connolly S.J., Schnell D.J., Page R.L., et al. Dose-response relations of azimilide in the management of symptomatic, recurrent, atrial fibrillation. Am J Cardiol 88 (2001) 974-979
4. Singer I., Al-Khalidi H., Niazi I., et al. Azimilide decreases recurrent ventricular tachyarrhythmias in patients with implantable cardioverter defibrillators. J Am Coll Cardiol 43 (2004) 44-46
5. Dorian P., Borggrefe M., Al-Khalidi H.R., et al. Placebo-controlled, randomized clinical trial of azimilide for prevention of ventricular tachyarrhythmias in patients with an implantable cardioverter defibrillator. Circulation 110 (2004) 3646-3654
6. Camm A.J., Pratt C.M., Schwartz P.J., et al., AzimiLide post Infarct surVival Evaluation (ALIVE) Investigators. Mortality in patients after a recent myocardial infarction. a randomized, placebo-controlled trial of azimilide using heart rate variability for risk stratification. for the. Circulation 109 (2004) 990-996
7. Roden D.M. Drug-induced prolongation of the QT interval. N Engl J Med 350 (2004) 1013-1022
8. Arking D.E., Chugh S.S., Chakravart A., and Spooner P.M. Genomics in sudden cardiac death. Circ Res 94 (2004) 712-723
9. Collett D. Modelling Survival Data in Medical Research. 2nd edition (2003), Chapman and Hall, London 15
10. Armitage P. Test for linear trend in proportions and frequencies. Biometrics 11 (1955) 375-386
11. Bazett H.C. An analysis of the time-relations of the electrocardiogram. Heart 7 (1920) 353-370
12. Julian D.G., Camm A.J., Frangin G., et al., European Myocardial Infarct Amiodarone Trial Investigators. Randomised trial of effect of amiodarone on mortality in patients with left-ventricular dysfunction after recent myocardial infarction. EMIAT. for the. Lancet 349 (1997) 667-674
13. Lehmann M.H., Hardy S., Archibald D., Quart B., and MacNeil D.J. Sex difference in risk of torsades de pointes with d,l-sotalol. Circulation 94 (1996) 2534-2541
14. Torp-Pedersen C., Moller M., Bloch-Thomsen P.E., et al., Danish Investigations of Arrhythmia and Mortality on Dofetilide Study Group. Dofetilide in patients with congestive heart failure and left ventricular dysfunction. N Engl J Med 341 (1999) 857-865
15. Kober L., Bloch-Thomsen P.E., Moller M., et al. Effect of dofetilide in patients with recent myocardial infarction and left ventricular dysfunction. a randomized trial. Lancet 356 (2000) 2052-2058
16. Bauman J.L., Bauernfeind R.A., Hoff J.V., Strasberg B., Swiryn S., and Rosen K.M. Torsades de pointes due to quinidine. observations in 31 patients. Am Heart J 107 (1984) 425-430
17. Minardo J.D., Heger J.J., Miles W.M., Zipes D.P., and Prystowsky E.N. Clinical characteristics of patients with ventricular fibrillation during antiarrhythmic drug therapy. N Engl J Med 319 (1988) 257-262
18. Nguyen P.T., Scheinman M.M., and Seger J. Polymorphous ventricular tachycardia. clinical characterization, therapy, and the QT interval. Circulation 74 (1986) 340-349
19. Roden D.M., Woosley R.L., and Primm R.K. Incidence and clinical features of the quinidine-associated long QT syndrome. implications for patient care. Am Heart J 111 (1986) 1088-1093
20. Amiodarone Trials Meta-Analysis Investigators. Effect of prophylactic amiodarone on mortality after acute myocardial infarction and in congestive heart failure. meta-analysis of individual data from 6500 patients in randomised trials. Lancet 350 (1997) 1417-1424
21. Waldo A.L., and Pratt C.M. Interpretation of clinical trials. how mortality trials relate to the therapy of atrial fibrillation. In: Saksena S., and Camm A.J. (Eds). Electrophysiological Disorders of the Heart. 1st edition (2005), Churchill Livingstone, New York, NY 189-206
22. Zeltser D., Justo D., Halkin A., Prokhorov V., Heller K., and Viskin S. Torsade de pointes due to noncardiac drugs. most patients have easily identifiable risk factors. Medicine 82 (2003) 282-290
23. Corey A., Al-Khalidi H., Brezovic C., et al. Azimilide pharmacokinetics and pharmacodynamics upon multiple oral dosing. Biopharm Drug Disp 20 (1999) 59-68
24. Viskin S. Post-tachycardia QT prolongation. maladjustment of the QT interval to the normal heart rate. Pacing Clin Electrophysiol 26 (2003) 659-661
25. Fenichel R.R., Malik M., Antzelevitch C., et al., Independent Academic Task Force. Drug-induced torsades de pointes and implications for drug development. for the. J Cardiovasc Electrophysiol 15 (2004) 475-495
26. Norata G.D., Pirillo A., and Catapano A.L. Statins and oxidative stress during atherogenesis. J Cardiovasc Risk 10 (2003) 181-189
27. Kumagai K., Nakashima H., and Saku K. The HMG-CoA reductase inhibitor atorvastatin prevents atrial fibrillation by inhibiting inflammation in a canine sterile pericarditis model. Cardiovasc Res 62 (2004) 105-111
28. Anderson J.L., Maycock C.A., Lappe D.L., et al., Intermountain Heart Collaborative Study Group. Frequency of elevation of C-reactive protein in atrial fibrillation. for the. Am J Cardiol 94 (2004) 1255-1259
29. Kowalewski M., Urban M., Mroczko B., and Szmitkowski M. Proinflammatory cytokines (IL-6, TNF-alpha) and cardiac troponin I (cTnI) in serum of young people with ventricular arrhythmias. Polskie Archiwum Medycyny Wewnetrznej 108 (2002) 647-651
30. + reveals that ischaemic arrhythmias are caused by independent effects of endogenous 'mediators' facilitated by interactions, and moderated by paradoxical antagonism. Br J Pharmacol 142 (2004) 352-366