Prediction of drug-induced QT interval prolongation in telemetered common marmosets

Journal of Toxicological Sciences

Volumn 33, Issue 3, 2008, Pages 315-325

  Tabo, Mitsuyasu ^a   Hara, Toshiko ^a   Sone, Sachiko ^a   Shishido, Nobuyuki ^a   Kuramoto, Shino ^a   Nakano, Kounosuke ^a   Onodera, Hideko ^a   Kimura, Kazuya ^a   Kobayashi, Kazuko ^a  

^a CHUGAI PHARMACEUTICAL CO LTD   (Japan)

Author keywords

Astemizole; Common marmosets; dl Sotalol; Individual rate correction; QT interval prolongation; Telemetry system

Indexed keywords

ASTEMIZOLE; NIFEDIPINE; PROPRANOLOL; SOTALOL;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; FEMALE; HEART RATE; LINEAR REGRESSION ANALYSIS; MALE; MARMOSET; NONHUMAN; PREDICTION; QT INTERVAL; QT PROLONGATION; RR INTERVAL; SENSITIVITY ANALYSIS; TELEMETRY;

CALLITHRIX JACCHUS;

EID: 48849100185     PISSN: 03881350     EISSN: 18803989     Source Type: Journal    
DOI: 10.2131/jts.33.315     Document Type: Article

References (41)

1. Ando, K., Hombo, T., Kanno, A., Ikeda, H., Imaizumi, M., Shimizu, N., Sakamoto, K., Kitani, S., Yamamoto, Y., Hizume, S., Nakai, K., Kitayama, T. and Yamamoto, K. (2005): QT PRODACT: In vivo QT assay with a conscious monkey for assessment of the potential for drug-induced QT interval prolongation. J. Pharmacol. Sci., 99, 487-500.
2. Antonaccio, M.J. and Gomoll, A. (1993): Pharmacologic basis of the antiarrhythmic and hemodynamic effects of sotalol. Am. J. Cardiol., 72, 27-37.
3. Bartlett, M.S. (1937): Properties of sufficiency and statistical tests. Proc. Roy. Soc., A160, 268-282.
4. Bazett, H.C. (1920): An analysis of the time-relations of electrocardiograms. Heart, 7, 353-370.
5. Benton, R.E., Sale, M., Flockhart, D.A. and Woosley, R.L. (2000): Greater quinidine-induced QTc interval prolongation in women. Clin. Pharmacol. Ther., 67, 413-418.
6. Carr, R.A., Pasutto, F.M., Lewanczuk, R.Z. and Foster, R.T. (1995): Protein binding of Sotalol enantiomers in young and elderly human and rat serum using ultrafiltration. Biopharm. Drug Dispos., 16, 705-712.
7. Dunnett, C.W. (1964): New tables for multiple comparisons with a control. Biometrics, 20, 482-491.
8. Fridericia, L.S. (1920): Die systolendauer im elektrokardiogramm bei normalen menschen und bei herzkranken. Acta. Med. Scand., 53, 469-486.
9. Guth, B.D., Germeyer, S., Kolb, W. and Markert, M. (2004): Developing a strategy for the nonclinical assessment of proarrhythmic risk of pharmaceuticals due to prolonged ventricular repolarization. J. Pharmacol. Toxicol. Methods, 49, 159-169.
10. Hanson, L.A., Bass, A.S., Gintant, G., Mittelstadt, S., Rampe, D. and Thomas, K. (2006): ILSI-HESI cardiovascular safety subcommittee initiative: evaluation of three non-clinical models of QT prolongation. J. Pharmacol. Toxicol. Methods, 54, 116-129.
11. Harada, T., Abe, J., Shiotani, M., Hamada, Y. and Horii, I. (2005): Effect of autonomic nervous function on QT interval in dogs. J. Toxicol. Sci., 30, 229-237.
12. Hayashi, S., Kii, Y., Tabo, M., Fukuda, H., Itoh, T., Shimosato, T., Amano, H., Saito, M., Morimoto, H., Yamada, K., Kanda, A., Ishitsuka, T., Yamazaki, T., Kiuchi, Y., Taniguchi, S., Mori, T., Shimizu, S., Tsurubuchi, Y., Yasuda, S., Kitani, S., Shimada, C., Kobayashi, K., Komeno, M., Kasai, C., Hombo, T. and Yamamoto, K. (2005): QT PRODACT: A multi-site study of in vitro action potential assays on 21 compounds in isolated guinea-pig papillary muscles. J. Pharmacol. Sci., 99, 423-437.
13. Holzgrefe, H.H., Cavero, I., Buchanan, L.V., Gill, M.W. and Durham, S.K. (2007): Application of a probabilistic method for the determination of drug-induced QT prolongation in telemetered cynomolgus monkeys: Effects of moxifloxacin. J. Pharmacol. Toxicol. Methods, 55, 244-254.
14. Hoppu, K., Tikanoja, T., Tapanainen, P., Remes, M., Saarenpaa-Heikkila, O. and Kouvalainen, K. (1991): Accidental astemizole overdose in young children. Lancet, 338, 538-540.
15. Horii, I., Kito, G., Hamada, T., Jikuzono, T., Kobayashi, K. and Hashimoto, K. (2002): Development of telemetry system in the common marmoset -cardiovascular effects of astemizole and nicardipine-. J. Toxicol. Sci., 27, 123-130.
16. ICH Harmonised Tripartite Guideline, The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals S7B. Recommended for adoption at step 4 of the ICH process on 12 May 2005 by the ICH Steering Committee. ICH; http://www.ich.org/.
17. JIS (1965): The t-test with F-test for homogeneity of variance. Significance test of difference between the two population means (standard deviations unknown, two-sided). Japanese Industry Standard Z9049.
18. Kano, M., Toyoshi, T., Iwasaki, S., Kato, M., Shimizu, M. and Ota, T. (2005): QT PRODACT: Usability of miniature pigs in safety pharmacology studies: assessment for drug-induced QT interval prolongation. J. Pharmacol. Sci., 99, 501-511.
19. Kawakami, K., Nagatomo, T., Abe, H., Kikuchi, K., Takemasa, H., Anson, B.D., Delisle, B.P., January, C.T. and Nakashima, Y. (2006): Comparison of HERG channel blocking effects of various β-blockers -implication for clinical strategy. Br. J. Pharmacol., 147, 642-652.
20. Kimura, M., Umemura, K., Ikeda, Y., Kosuge, K., Mizuno, A., Nakanomyo, H., Ohashi, K. and Nakashima, M. (1996): Pharmacokinetics and pharmacodynamics of (±)-sotalol in healthy male volunteers. Br. J. Clin. Pharmacol., 42, 583-588.
21. Kirsch, G.E., Trepakova, E.S., Brimecombe, J.C., Sidach, S.S., Erickson, H.D., Kochan, M.C., Shyjka, L.M., Lacerda, A.E. and Brown, A.M. (2004): Variability in the measurement of hERG potassium channel inhibition: Effects of temperature and stimulus pattern. J. Pharmacol. Toxicol. Methods, 50, 93-101.
22. Malik, M., Farbom, P., Batchvarov, V., Hnatkova, K. and Camm, A.J. (2002): Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval. Heart, 87, 220-228.
23. Matsunaga, T., Mitsui, T., Harada, T., Inokuma, M., Murano, H. and Shibutani, Y. (1997): QT corrected for heart rate and relation between QT and RR intervals in beagle dogs. J. Pharmacol. Toxicol. Methods, 38, 201-209.
24. Miyazaki, H. and Tagawa, M. (2002): Rate-correction technique for QT interval in long-term telemetry ECG recording in beagle dogs. Exp. Anim., 51, 465-475.
25. Omata, T., Kasai, C., Hashimoto, M., Hombo, T. and Yamamoto, K. (2005): QT PRODACT: Comparison of non-clinical studies for drug-induced delay in ventricular repolarization and their role in safety evaluation in humans. J. Pharmacol. Sci., 99, 531-541.
26. 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. and Hammond, T.G. (2003): 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. Cardiovasc. Res., 58, 32-45.
27. Reinoehl, J., Frankovich, D., Machado, C., Kawasaki, R., Baga, J.J., Pires, L.A., Steinman, R.T., Fromm, B.S. and Lehmann, M.H. (1996): Probucol-associated tachyarrhythmic events and QT prolongation: importance of gender. Am. Heart J., 131, 1184-1191.
28. Rocher, I., Decourt, S., Leneveu, A., Lebrec, D., Rosier, S.P. and Flouvat, B. (1985): Hemodynamic and pharmacokinetic study of propranolol and atenolol in cirrhosis patients. Int. J. Clin. Pharmacol. Ther. Toxicol., 23, 406-410.
29. Sarma, J.S.M., Venkataraman, K., Nicod, P., Polikar, R., Smith, J., Schoenbaum, M.P. and Singh, B.N. (1990): Circadian rhythmicity of rate-normalized QT interval in hypothyroidism and its significance for development of class III antiarrhythmic agents. Am. J. Cardiol., 66, 959-963.
30. Saviuc, P., Danel, V. and Dixmerias, F. (1993): Prolonged QT interval and torsade de pointes following astemizole overdose. J. Toxicol. Clin. Toxicol., 31, 121-125.
31. Schnelle, K. and Garrett, E.R. (1973): Pharmacokinetics of the β-adrenergic blocker Sotalol in dogs. J. Pharm. Sci., 62, 362-375.
32. Spence, S., Soper, K., Hoe, C.M. and Coleman, J. (1998): The heart rate-corrected QT interval of conscious beagle dogs: A formula based on analysis of covariance. Toxicol. Sci., 45, 247-258.
33. Tabo, M., Nakamura, M., Kimura, K. and Ito, S. (2006): QT-RR relationships and suitable QT correction formulas for halothane-anesthetized dogs. J. Toxicol. Sci., 31, 381-390.
34. Toyoshima, S., Kanno, A., Kitayama, T., Sekiya, K., Nakai, K., Haruna, M., Mino, T., Miyazaki, H., Yano, K. and Yamamoto, K. (2005): QT PRODACT: In vivo QT assay in the conscious dog for assessing the potential for QT interval prolongation by human pharmaceuticals. J. Pharmacol. Sci., 99, 459-471.
35. Varro, A., Lathrop, D. A. and Surawicz, B. (1990): Effects of propranolol on premature action potentials in canine Purkinje and ventricular muscle. J. Cardiovasc. Pharmacol., 16, 757-763.
36. Vorperian, V.R., Zhou, Z., Mohammad, S., Hoon, T.J., Studenik, C. and January, C.T. (1996): Torsade de pointes with an antihistamine metabolite: Potassium channel blockade with desmethylastemizole. J.Am. Coll. Cardiol., 28, 1556-1561.
37. Webster, R., Leishman, D. and Walker, D. (2002): Towards a drug concentration effect relationship for QT prolongation and torsades de pointes. Curr. Opin. Drug Discov. Devel., 5, 116-126.
38. Welch, B.L. (1938): The significance of the difference between two means when the population variances are unequal. Biometrika, 29, 350-362.
39. Zhang, S., Zhou, Z., Gong, Q., Makielski, J.C. and January, C.T. (1999): Mechanism of block and identification of the verapamil binding domain to HERG potassium channels. Circ. Res., 84, 989-998.
40. Zhou, Z., Vorperian, V.R., Gong, Q., Zhang, S. and January, C.T. (1999): Block of HERG potassium channels by the antihistamine astemizole and its metabolites desmethylastemizole and norastemizole. J. Cardiovasc. Electrophysiol., 10, 836-843.
41. Zylber-Katz, E., Turetz-Abramovitch, M., Koren, G. and Levy, M. (1988): Pharmacokinetic interaction between nifedipine and propranolol. Fundam. Clin. Pharmacol., 2, 29-35.