Dose-response effects of sotalol on cardiovascular function in conscious, freely moving cynomolgus monkeys

British Journal of Pharmacology

Volumn 154, Issue 7, 2008, Pages 1439-1445

  Lynch III, J J ^a   Wilson, A W ^b   Hernandez, L E ^a   Nelson, R A ^a   Marsh, K C ^a   Cox, B F ^a   Mittelstadt, S W ^a  

^a ABBOTT LABORATORIES   (United States)

^b Singapore Science Park II   (Singapore)

Author keywords

Arterial blood pressure; Body temperature; Cardiovascular; Electrocardiogram; Heart rate; Monkey; QT prolongation; Safety pharmacology; Sotalol; Telemetry

Indexed keywords

SOTALOL;

ANIMAL EXPERIMENT; ARTERIAL PRESSURE; ARTICLE; BODY TEMPERATURE; CARDIOVASCULAR FUNCTION; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFECT; ELECTROCARDIOGRAM; HEART RATE; MACACA; MALE; NONHUMAN; PR INTERVAL; PRIORITY JOURNAL; QRS COMPLEX; QT INTERVAL; RR INTERVAL; TELEMETRY;

ADMINISTRATION, ORAL; ADRENERGIC BETA-ANTAGONISTS; ANIMALS; BLOOD PRESSURE; BODY TEMPERATURE; DOSE-RESPONSE RELATIONSHIP, DRUG; ELECTROCARDIOGRAPHY; HEART RATE; MACACA FASCICULARIS; MALE; MODELS, ANIMAL; SOTALOL; SPECIES SPECIFICITY; TELEMETRY;

EID: 48149110309     PISSN: 00071188     EISSN: 14765381     Source Type: Journal    
DOI: 10.1038/bjp.2008.206     Document Type: Article

References (30)

1. Anderson J, Prystowsky EN (1999). Sotalol: an important new antiarrthymic. Am Heart J 137: 388-409.
2. Ando K, Hombo T, Kanno A, Ikeda H, Imaizumi M, Shimizu N et al. (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.
3. Antonaccio MJ, Gomoll A (1990). Pharmacology, pharmacodynamics and pharmacokinetics of sotalol. Am J Cardiol 65: 12A-21A.
4. Authier S, Tanguay J-F, Gauvin D, Di Fruscia R, Fournier S, Chaurand F et al. (2007a). A cardiovascular monitoring system used in conscious cynomologus monkeys for regulatory safety pharmacology: part 1: non-pharmacological validation. J Pharmacol Toxicol Meth 56: 115-121.
5. Authier S, Tanguay J-F, Gauvin D, Di Fruscia R, Troncy E (2007b). A cardiovascular monitoring system used in conscious cynomologus monkeys for regulatory safety pharmacology: part 2: pharmacological validation. J Pharmacol Toxicol Meth 56: 122-130.
6. Batey AJ, Doe CPA (2002). A method for QT correction based on beat-to-beat analysis of the QT/RR interval relationship in conscious telemetred beagle dogs. J Pharmacol Toxicol Meth 48: 11-19.
7. Cammu G, Geelen P, Baetens P, De Vos J, Demeyer I (1999). Two cases of torsades de pointes caused by sotalol therapy. Resuscitation 40: 49-51.
8. Carr RA, Foster RT, Lewanczuk RZ, Hamilton PG (1992). Pharmacokinetics of sotalol enantiomers in humans. J Clin Pharmacol 31: 1105-1109.
9. Chaves AA, Keller WJ, O'Sullivan S, Williams MA, Fitzgerald LE, McPherson HE et al. (2006). Cardiovascular monkey telemetry: sensitivity to detect QT interval prolongation. J Pharmacol Toxicol Meth 54: 150-158.
10. Fossa AA, Wisialowski T, Crimin K, Wolfgang E, Couderc J-P, Hinterseer M et al. (2007). Analyses of dynamic beat-to-beat QT-TQ interval (ECG restitution) changes in humans under normal sinus rhythm and prior to an event of torsades de pointes during QT prolongation caused by sotalol. Ann Noninvasive Electrocardiol 12: 338-348.
11. Fridericia LS (1920). The systolic period in electrocardiograms of normal people and those with heart conditions. Acta Med Scand 53: 469-486.
12. Gomoll AW, Lekich RF, Bartek MJ, Comereski CR, Antonaccio MJ (1990). Comparability of the electrophysiologic responses and plasma and myocardial tissue concentrations of sotalol and its d sterereoisomer in the dog. J Cardiovasc Pharmacol 16: 204-211.
13. Hamlin RL, Kijtawornrat A, Keene BW, Hamlin DM (2003). QT and RR intervals in conscious and anesthetized guinea pigs with highly varying RR intervals and given QTc-lengthening test articles. Toxicol Sci 76: 437-442.
14. Hess P, Rey M, Wanner D, Steiner B, Clozel M (2007). Measurements of blood pressure and electrocardiogram in conscious freely moving guinea pigs: a model for screening QT interval prolongation effects. Lab Animal 41: 470-480.
15. Kano M, Toyoshi T, Iwasaki S, Kato M, Shimizu M, 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.
16. Kehoe RF, MacNeil DJ, Zheutlin TA, Ezri MD, Nazari J, Spangenberg RB et al. (1993). Safety and efficacy of oral sotalol for sustained ventricular tachyarrhythmias refractory to other antiarrhythmic agents. Am J Cardiol 72: 56A-66A.
17. Lake-Bruse KD, Wilkinson JT, Herberth MT, Chengelis CP, Schaefer GJ (2004). Altered PR, QRS, RR, and QT following orally administered dofetilide, sotalol, or pinacidil to radiotelemetry-implanted dogs. J Pharmacol Toxicol Meth 49: 223.
18. Le Coz F, Funck-Brentano C, Poirier J-M, Kibleur Y, Mazoit FX, Jaillon P (1992). Prediction of sotalol-induced maximum steady-state QTc prolongation from single-dose administration in healthy volunteers. Clin Pharmacol Ther 52: 417-426.
19. Lehtonen A, Fodstad H, Laitinen-Forsblom P, Toivonen L, Kontula K, Swan H (2007). Further evidence of inherited long QT syndrome gene mutations in antiarryhthmic drug-associated torsades de pointes. Heart Rhythm 4: 603-610.
20. McComb JM, McGovern B, McGowan JB, Ruskin JN, Garan H (1987). Electrophysiologic effects of d-sotalol in humans. J Am Coll Cardiol 10: 211-217.
21. Mittelstadt SW, Maynard AE, Benn DR, Lowe ER, Kostreva DR (1997). Effects of azimilide and d,l-sotalol on the heart rate and blood pressure response to isoproterenol in anesthetized rats. Cardiovasc Drugs Ther 11: 591-598.
22. Sahar DI, Reiffel JA, Bigger Jr JT, Squatrito A, Kidwell GA (1989). Efficacy, safety, and tolerance of d-sotalol in patients with refractory superventricular tachyarrhythmias. Am Heart J 117: 562-568.
23. Kr blockade: comparison with urethane anesthesia. J Pharmacol Sci 99: 185-190.
24. Sasaki H, Shimizu N, Suganami H, Yamamoto K (2005). QT PRODACT: inter-facility variability in electrocardiographic and hemodynamic parameters in conscious dogs and monkeys. J Pharmacol Sci 99: 513-522.
25. Kr blockade. Eur J Pharmacol 507: 169-177.
26. US Food and Drug Administration (FDA) (2001). ICH guidance for industry: S7A safety pharmacology studies for human pharmaceuticals. US FDA, Rockville, MD, USA.
27. Vormberge T, Hoffmann M, Himmel H (2006). Safety pharmacology assessment of drug-induced QT-prolongation in dogs with reduced repolarization reserve. J Pharmacol Toxicol Meth 54: 130-140.
28. Wang T, Bergstrand RH, Thompson KA, Siddoway LA, Duff HJ, Woosley RL et al. (1986). Concentration-dependent pharmacologic properties of sotalol. Am J Cardiol 57: 1160-1165.
29. Ward KW, Smith BR (2004). A comprehensive quantitative and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog, and monkey to humans. I. Clearance. Drug Metab Dispos 32: 603-611.
30. Zuber R, Anzenbacherová E, Anzenbacher P (2002). Cytochromes P450 and experimental models of drug metabolism. J Cell Molec Med 26: 189-198.