New preclinical guidelines on drug effects on ventricular repolarization: Safety pharmacology comes of age

Journal of Pharmacological and Toxicological Methods

Volumn 49, Issue 3, 2004, Pages 153-158

  Kinter, Lewis B ^a   Siegl, Peter K S ^b   Bass, Alan S ^b  

^a ASTRAZENECA   (United Kingdom)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; CARDIOVASCULAR AGENT;

BLOOD LEVEL; CARDIOTOXICITY; CARDIOVASCULAR SYSTEM; CENTRAL NERVOUS SYSTEM; CLINICAL TRIAL; DRUG EFFECT; DRUG SAFETY; ELECTROCARDIOGRAM; HEART REPOLARIZATION; HEART VENTRICLE TACHYCARDIA; HUMAN; HYPOCALCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; KIDNEY FUNCTION; META ANALYSIS; NONHUMAN; PERIPHERAL NERVOUS SYSTEM; QT INTERVAL; QT PROLONGATION; RESPIRATORY SYSTEM; REVIEW; RISK ASSESSMENT; SENSE ORGAN; SIDE EFFECT; TORSADE DES POINTES;

EID: 2542482516     PISSN: 10568719     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vascn.2004.03.007     Document Type: Article

References (17)

1. Ackerman M.J. The long QT syndrome: Ion channel diseases of the heart. Mayo Clinic Proceedings. 73:1998;250-269
2. Anderson M.E., Al-Khatib S.M., Roden D.M., Califf R.M. Cardiac repolarization: Current knowledge, critical gaps and new approaches to drug development and patient management. American Heart Journal. 144:2002;769-781
3. Anon. BioCentury. 11:2003;A1
4. Biomarkers Definitions Working Group Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology & Therapeutics. 69:2001;89-95
5. De Ponti F., Poluzzi E., Montanaro N. Organising evidence on QT prolongation and occurrence of torsades de pointes with non-antiarrhythmic drugs: A call for consensus. European Journal of Clinical Pharmacology. 57:2001;185-209
6. Hammond T.G., Carlsson L., Davis A.S., Lynch W.G., MacKenzie I., Redfern W.S., Sullivan A.T., Camm A.J. Methods of collecting and evaluating non-clinical cardiac electrophysiology data in pharmaceutical industry: Results of an international survey. Cardiovascular Research. 49:2001;741-750
7. Haverkamp W., Breithart G., Camm A.J., Janse M.J., Rosen M.R., Antzelevitch C., Escande D., Franz M., Malik M., Moss A., Shah R. The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs: Clinical and regulatory implications. Cardiovascular Research. 47:2000;219-233
8. Kinter L.B., Valentin J.P. Safety pharmacology and risk assessment. Fundamental & Clinical Pharmacology. 16:2002;175-182
9. Moss A.J. The QT interval and torsade de pointes. Drug Safety. 21:1999;5-10
10. Redfern W.S., Carlsson L., Davis A.S., Lynch W.G., MacKenzie I., Palethorpe S., Siegl P.K.S., Strang I., Sullivan A.T., Wallis R., Camm A.J., Hammond T.G. 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. Cardiovascular Research. 58:2003;1-44
11. Spence S., Soper K., Hoe C.-M., Coleman J. The rate-corrected QT interval of conscious beagle dogs: A formula based on analysis of covariance. Toxicological Sciences. 45:1998;247-258
12. Temple R. Are surrogate markers adequate to assess cardiovascular disease drugs? Journal of the American Medical Association. 282:1999;790-795
13. Thomas S.H.L. Drugs, QT interval abnormalities and ventricular arrhythmias. Adverse Drug Reactions and Toxicology Reviews. 13:1994;77-102
14. Viskin S. Long QT syndromes and torsade de pointes. Lancet. 354:1999;1625-1633
15. Vital B.O., Fontana M.D., Di A., Heluany F.F., Leite G.B. Actions of Androctonus australis and Leiurus quintquestriatus venoms in the rat isolated atria and anesthetized rat; effect of magnesium and lidocaine. Journal of Natural Toxins. 11:2002;1-13
16. Zbinden G. Pharmacological methods in toxicology. 1979;613 Pergamon Press, Elmsford, NY
17. Zbinden G. Neglect of function and obsession with structure in toxicity testing. Proceedings, 9th International Congress of Pharmacology. vol. 1:1984;43-49 Macmillan, New York