QT PRODACT: Usability of miniature pigs in safety pharmacology studies: Assessment for drug-induced QT interval prolongation

Journal of Pharmacological Sciences

Volumn 99, Issue 5, 2005, Pages 501-511

  Kano, Mayumi ^a,b   Toyoshi, Tohru ^a,b   Iwasaki, Sakae ^b   Kato, Masami ^b   Shimizu, Masayoshi ^b   Ota, Takao ^b  

^a Japan Pharmaceutical Manufacturers Association JPMA/QT PRODACT   (Japan)

^b Nihon Bioresearch Inc   (Japan)

Author keywords

dl propranolol; dl sotalol; Haloperidol; Miniature pig; QT interval

Indexed keywords

HALOPERIDOL; PROPRANOLOL; SOTALOL;

ANIMAL EXPERIMENT; ARTICLE; BLOOD PRESSURE; CONCENTRATION RESPONSE; CONTROLLED STUDY; DRUG SAFETY; ELECTROCARDIOGRAM; HEART RATE; IN VIVO CULTURE; MALE; NONHUMAN; QT PROLONGATION; SWINE; TELEMETRY; ANIMAL; ANIMAL MODEL; BLOOD; CHEMICALLY INDUCED DISORDER; DRUG EFFECT; ELECTROCARDIOGRAPHY; FACTUAL DATABASE; LONG QT SYNDROME; MINIPIG;

ANIMALS; BLOOD PRESSURE; DATABASES, FACTUAL; ELECTROCARDIOGRAPHY; HALOPERIDOL; HEART RATE; LONG QT SYNDROME; MALE; MODELS, ANIMAL; PROPRANOLOL; SOTALOL; SWINE; SWINE, MINIATURE; TELEMETRY;

EID: 33645059979     PISSN: 13478613     EISSN: 13478648     Source Type: Journal    
DOI: 10.1254/jphs.QT-C13     Document Type: Article

References (38)

1. Kates RA, Zaggy AP, Norfleet EA, Heath KR. Comparative cardiovascular effects of verapamil, nifedipine, and diltiazem during halothane anesthesia in swine. Anesthesiology. 1984;61:10-18.
2. Egashira K, Pipers FS, Morgan JP. Effects of cocaine on epicardial coronary artery reactivity in miniature swine after endothelial injury and high cholesterol feeding. In vivo and in vitro analysis. J Clin Invest. 1991;88:1307-1314.
3. Hidaka H, Sawada S, Sato R, Oka H, Yasuda Y. Pharmacological comparison of captopril and MK-422 by a new method for measuring activity of angiotensin converting enzyme (ACE). Jpn Circ J. 1985;49:1175-1179.
4. Hsu C. Uses of pigs in biomedical research: strengths and limitations. In: Roberts HR, Dodds WJ, editors. Pig model for biomedical research. Taiwan: Pig Research Institute; 1982. p. 3-10.
5. Kriwisky M, Perry GY, Tarchitsky D, Gutman Y, Kishon, Y. Haloperidol-induced torsades de pointes. Chest. 1990;98:482-484.
6. Lehmann MH, Hardy S, Archibald D, quart B, MacNeil DJ. Sex difference in risk of torsade de pointes with dl-sotalol. Circulation. 1996;15;94:2535-2541.
7. Clozel JP, Danchin N, Genton P, Thomas JL, Cherrier F. Effects of propranolol and of verapamil on heart rate and blood pressure in hyperthyroidism. Clin Pharmacol Ther. 1984;36:64-69.
8. Forsman A, Ohman R. Pharmacokinetic studies on haloperidol in man. Curr Ther Res Clin Exp. 1976;20:319-336.
9. Suzuki A, Tsutsumi H, Kusakabe K, Kuwahara M, Sugano S, Tanigawa M. Establishment of a 24-hour electrocardiogram recording system using a Holter recorder for miniature swine. Lab Anim. 1998;32:165-172.
10. Satoh Y, Sugiyama A, Tamura K, Hashimoto K. Effect of magnesium sulfate on the haloperidol-induced QT prolongation assessed in the canine in vivo model under the monitoring of monophasic action potential. Jpn Circ J. 2000;64:445-451.
11. Mortensen E, Tande PM, Klow NE, Refsum H. Plasma concentrations and haemodynamic effects of d-sotalol after beta-blockade in dogs. Pharmacol Toxicol. 1990;67:420-425.
12. Wojcicki J, Sulzyc-Bielicka V, Kutrzeba J, Gawronska-Szklarz B, Drozdzik M, Sterna Z. Studies on the pharmacokinetics and pharmacodynamics of propranolol in hyperlipidemia. J Clin Pharmacol. 1999;39:826-833.
13. Lalonde RL, Pieper JA, Straka RJ, Bottorff MB, Mirvis DM. Propranolol pharmacokinetics and pharmacodynamics after single doses and at steady-state. Eur J Clin Pharmacol. 1987;33:315-318.
14. Heinzow BG, Somogyi A, McLean AJ. Influence of hydralazine on the pharmacokinetics of orally administered d-propranolol and lidocaine in conscious dogs. Arch Int Pharmacodyn Ther. 1987;286:5-14.
15. Tse FL, Sanders TM, Reo JP. Bioavailability of propranolol in the dog. Arch Int Pharmacodyn Ther. 1980;248:180-189.
16. Bazett HC. An analysis of the time-relations of electrocardiograms. Heart. 1920;7:353-370.
17. Fridericia LS. Die systolendauer im electrokardiogramm bei normalen menshen und bei herzkranken. Acta Med Scand. 1920;53:469-486. (in German)
18. Spence S, Soper K, Hoe C-M, Coleman J. The heart rate-corrected QT interval of conscious beagle dogs: a formula based on analysis of covariance. Toxicol Sci. 1998;45:247-258.
19. Miyazaki H, Tagawa M. Rate-correction technique for QT interval in long-term telemetry ECG recording in beagle dogs. Exp Anim. 2002;51:465-475.
20. Oguchi E, Kanba S, Watanabe K, Yagi G. Determination of haloperidol in serum by Markit-M haloperidol and its clinical application. Jpn J Neuropsychopharmacol. 1994;16:233-239.
21. Ahnoff M, Ervik M, Lagerstrom PO, Persson BA, Vessman J. Drug level monitoring: cardiovascular drugs. J Chromatogr. 1985;340:73-138.
22. Kuwahara M, Suzuki A, Tsutsumi H, Tanigawa M, Tsubone H, Sugano S. Power spectral analysis of heart rate variability for assessment of diurnal variation of autonomic nervous activity in miniature swine. Lab Anim Sci. 1999;49:202-208.
23. Hammond TG, Carlsson L, Davis AS, Lynch WG, MacKenzie I, Redfern WS, et al. Methods of collecting and evaluating nonclinical cardiac electrophysiology data in the pharmaceutical industry: results of an international survey. Cardiovasc Res. 2001;49:741-750.
24. Malik M, Farbom P, Batchvarov V, Hnatkova K, Camm AJ. Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval. Heart. 2002;87:220-228.
25. Batchvarov VN, Ghuran A, Smetana P, Hnatkova K, Harries M, Dilaveris P, et al. QT-RR relationship in healthy subjects exhibits substantial intersubject variability and high intrasubject stability. Am J Physiol Heart Circ Physiol. 2002;282:H2356-H2363.
26. Suessbrich H, Schonherr R, Heinemann SH, Attali B, Lang F, Busch AE. The inhibitory effect of the antipsychotic drug haloperidol on HERG potassium channels expressed in Xenopus oocytes. Br J Pharmacol. 1997;120:968-974.
27. Sharma ND, Rosman HS, Padhi ID, Tisdale JE. Torsades de pointes associated with intravenous haloperidol in critically ill patients. Am J Cardiol. 1998;81:238-240.
28. Settle EC Jr, Ayd FJ Jr. Haloperidol: a quarter century of experience. J Clin Psychiatry. 1983;44:440-448.
29. Imagawa A, Kawamoto T, Yoshino K, Ishikawa K. Haloperidol-induced torsades de pointes. J Jpn As Acute Med. 1993;4:369-373.
30. Desai M, Tanus-Santos JE, Li L, Gorski JC, Arefayene M, Liu Y, et al. Pharmacokinetics and QT interval pharmacodynamics of oral haloperidol in poor and extensive metabolizers of CYP2D6. Pharmacogenomics J. 2003;3:105-113.
31. Toyoshima S, Kanno A, Kitayama T, Sekiya K, Nakai K, Haruma M, et al. QT PRODACT: In vivo QT assay in the conscious dog for assessing the potential for QT interval prolongation by human pharmaceuticals. J Pharmacol Sci. 2005;99:459-471.
32. Ando K, Hombo T, Kanno A, Ikeda H, Imaizumi M, Shimizu N, et al. QT PRODACT: In vivo QT assay with a conscious monkey for assessment of the potential for drug-induced QT interval prolongation. J Pharmacol Sci. 2005;99:487-500.
33. Tisdale JE, Kambe JC, Chow MS, Yeston NS. The effect of haloperidol on ventricular fibrillation threshold in pigs. Pharmacol Toxicol. 1991;69:327-329.
34. Milne JR, Ward DE, Spurrell RA, Camm AJ. The long QT syndrome; effects of drugs and left stellate ganglion block. Am Heart J. 1982;104:194-198.
35. Varro A, Nakaya Y, Elharrar V, Surawicz B. Effect of antiarrhythmic drugs on the cycle length-dependent action potential duration in dog Purkinje and ventricular muscle fibers. J Cardiovasc Pharmacol. 1986;8:178-185.
36. Hayashi S, Kii, Y, Tabo M, Fukuda H, Itoh T, Shimosato T, et al. QT PRODACT: A multi-site study of in vitro action potential assays on 21 compounds in isolated guinea-pig papillary muscles. J Pharmacol Sci. 2005;99:423-437.
37. Weissenburger J, Davy JM, Chezalviel F. Experimental models of torsades de pointes. Fundam Clin Pharmacol. 1993;7:29-38.
38. Sasaki H, Shimizu N, Suganami H, Yamamoto K. QT PRODACT: Inter-facility variability in electrocardiographic and hemodynamic parameters in conscious dogs and monkeys. J Pharmacol Sci. 2005;99:513-522.