Comparison of different QT correction methods for nonclinical safety assessment in ketamine-anesthetized Indian rhesus monkeys (Macaca mulatta)

References

• [CCSEA] Committee for Control And Supervision of Experiments on Animals 2010. Guidelines for Laboratory Animal Facility. Ministry of Environment & Forests, Government of India.
   Google Scholar
• [FDA] Food and Drug Administration, HHS. 2005. International Conference on Harmonisation; guidance on E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs; availability. Notice. Fed Regist. 70(202):61134–61135.
   PubMedGoogle Scholar
• [ICH E14/S7B Q&As] ICH E14/S7B Implementation Working Group 2022. Clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential: questions and answers.
   Google Scholar
• Ahnve S. 1985. Correction of the QT interval for heart rate: review of different formulas and the use of Bazett’s formula in myocardial infarction. Am Heart J. 109(3 Pt 1):568–574.
   PubMed Web of Science ®Google Scholar
• Al-Khatib SM, LaPointe NM, Kramer JM, Califf RM. 2003. What clinicians should know about the QT interval. JAMA. 289(16):2120–2127.
   PubMed Web of Science ®Google Scholar
• Al-Tweigeri T, Dent S, Al Sayed A, Mohty D, Suleman K, Ajarim D, Raef H, Echahidi N. 2021. Using the appropriate formula for QT measurement can save lives. Hematol Oncol Stem Cell Ther. S1658-3876(21):00058–00053.
   Google Scholar
• Andršová I, Hnatkova K, Šišáková M, Toman O, Smetana P, Huster KM, Barthel P, Novotný T, Schmidt G, Malik M. 2021. Influence of heart rate correction formulas on QTc interval stability. Sci Rep. 11(1):14269.
   PubMed Web of Science ®Google Scholar
• Bazett H. 1997. An analysis of the time-relations of electrocardiograms. Ann Noninv Electrocard. 2(2):177–194.
   Google Scholar
• Bhatt LK, Shah CR, Patel RJ, Patel SD, Patel SR, Patel VA, Patel JH, Dwivedi P, Shah NA, Sundar RS, et al. 2022. QT correction formulae: comparison of different heart rate correction methods in Indian rhesus monkeys. PREPRINT (Version 1) available at Research Square. https://doi.org/10.21203/rs.3.rs-2245938/v1
   Google Scholar
• Cawthon Lang KA. 2005. Primate factsheets: rhesus macaque (Macaca mulatta). https://primate.wisc.edu/primate-info-net/ pin-factsheets/pin-factsheet-rhesus-macaque/
   Google Scholar
• Chaves AA, Keller WJ, O'Sullivan S, Williams MA, Fitzgerald LE, McPherson HE, Goykhman D, Ward PD, Hoe CM, Mixson L, et al. 2006. Cardiovascular monkey telemetry: sensitivity to detect QT interval prolongation. J Pharmacol Toxicol Methods. 54(2):150–158.
   PubMedGoogle Scholar
• Dmitrienke AA, Sides GD, Winters KJ, Kovacs RJ, Rebhun DM, Bloom JC, Groh W, Eisenberg PR. 2005. Electrocardiogram reference ranges derived from a standardized clinical trial population. Drug Information J. 39(4):395–405.
   Google Scholar
• Fridericia LS. 1920. Die systolendauer im elektrokardiogramm bei normalen menschen und bei Herzkranken. Acta Medica Scandinavica. 53(1):469–486.
   Google Scholar
• Garnett CE, Zhu H, Malik M, Fossa AA, Zhang J, Badilini F, Li J, Darpö B, Sager P, Rodriguez I. 2012. Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects. Am Heart J. 163(6):912–930.
   PubMed Web of Science ®Google Scholar
• Gauvin DV, Tilley LP, Smith FW, Jr, Baird TJ. 2006. Electrocardiogram, hemodynamics, and core body temperatures of the normal freely moving cynomolgus monkey by remote radiotelemetry. J Pharmacol Toxicol Methods. 53(2):140–151.
   PubMedGoogle Scholar
• Guideline ICH S7A. 2001. Safety pharmacology studies for human pharmaceuticals S7A. Fed Regist. 66:36791–36792.
   PubMedGoogle Scholar
• Guideline ICH S7B. 2005. The non-clinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals. http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html
   Google Scholar
• Guth BD. 2007. Preclinical cardiovascular risk assessment in modern drug development. Toxicol Sci. 97(1):4–20.
   PubMed Web of Science ®Google Scholar
• Guth BD, Bass AS, Briscoe R, Chivers S, Markert M, Siegl PK, Valentin JP. 2009. Comparison of electrocardiographic analysis for risk of QT interval prolongation using safety pharmacology and toxicological studies. J Pharmacol Toxicol Methods. 60(2):107–116.
   PubMedGoogle Scholar
• Hassimoto M, Harada T, Harada T. 2004. Changes in hematology, biochemical values, and restraint ECG of rhesus monkeys (Macaca mulatta) following 6‐month laboratory acclimation. J Med Primatol. 33(4):175–186.
   PubMed Web of Science ®Google Scholar
• Hassimoto M, Harada T, Kaga N, Murano H, Obata M. 2002. Accurate evaluation of QT interval in conscious rhesus monkeys (Macaca mulatta) by use of Holter ECG. J Electrocardiol. 35(4):333–342.
   PubMed Web of Science ®Google Scholar
• Hodges M. 1983. Bazett’s QT correction reviewed: evidence that a linear QT correction for heart rate is better. J Am Coll Cardiol. 1:694.
   Web of Science ®Google Scholar
• Holzgrefe HH, Cavero I, Gleason CR, Warner WA, Buchanan LV, Gill MW, Burkett DE, Durham SK. 2007. Novel probabilistic method for precisely correcting the QT interval for heart rate in telemetered dogs and cynomolgus monkeys. J Pharmacol Toxicol Methods. 55(2):159–175.
   PubMedGoogle Scholar
• Holzgrefe H, Ferber G, Champeroux P, Gill M, Honda M, Greiter-Wilke A, Baird T, Meyer O, Saulnier M. 2014. Preclinical QT safety assessment: cross-species comparisons and human translation from an industry consortium. J Pharmacol Toxicol Methods. 69(1):61–101.
   PubMed Web of Science ®Google Scholar
• Hom GJ, Bach TJ, Carroll D, Forrest MJ, Mariano MA, Trainor CE, Wang PR, MacIntyre DE. 1999. Comparison of cardiovascular parameters and/or serum chemistry and hematology profiles in conscious and anesthetized rhesus monkeys (Macaca mulatta). J Am Assoc Lab Anim Sci. 38(2):60–64.
   Google Scholar
• Hotchkiss CE, Wang C, Slikker W. 2007. Effect of prolonged ketamine exposure on cardiovascular physiology in pregnant and infant rhesus monkeys (Macaca mulatta). J Am Assoc Labor Anim Sci. 46(6):21–28.
   PubMed Web of Science ®Google Scholar
• Indik JH, Pearson EC, Fried K, Woosley RL. 2006. Bazett and Fridericia QT correction formulas interfere with measurement of drug-induced changes in QT interval. Heart Rhythm. 3(9):1003–1007.
   PubMed Web of Science ®Google Scholar
• Koga T, Kuwano K, Kito G, Kanefuji K. 2007. Evaluation of QT interval using a linear model in individual cynomolgus monkeys. J Pharmacol Toxicol Methods. 55(3):248–253.
   PubMedGoogle Scholar
• Kupper JL, Kessler MJ, Clayton JD, Brown RJ. 1981. Establishment of normal electrocardiographic values for a colony of rhesus monkeys (Macaca mulatta) under sedated and unsedated conditions. J Med Primatol. 10(6):329–335.
   PubMed Web of Science ®Google Scholar
• Lee JI, Hong SH, Lee SJ, Kim YS, Kim MC. 2003. Immobilization with ketamine HCl and tiletamine-zolazepam in cynomolgus monkeys. J Vet Sci. 4(2):187–191.
   PubMedGoogle Scholar
• Leishman DJ, Beck TW, Dybdal N, Gallacher DJ, Guth BD, Holbrook M, Roche B, Wallis RM. 2012. Best practice in the conduct of key nonclinical cardiovascular assessments in drug development: current recommendations from the Safety Pharmacology Society. J Pharmacol Toxicol Methods. 65(3):93–101.
   PubMed Web of Science ®Google Scholar
• Li M, Ramos LG. 2017. Drug-induced QT prolongation and torsades de pointes. P T. 42(7):473.
   PubMedGoogle Scholar
• Miyazaki H, Tagawa M. 2002. Rate-correction technique for QT interval in long-term telemetry ECG recording in beagle dogs. Exp Anim. 51(5):465–475.
   PubMed Web of Science ®Google Scholar
• Naccarato EF, Hunter WS. 1979. Anaesthetic effects of various ratios of ketamine and xylazine in rhesus monkeys (Macaca mulatta). Lab Anim. 13(4):317–319.
   PubMedGoogle Scholar
• Nakayama S, Koie H, Kato-Tateishi M, Pai C, Ito-Fujishiro Y, Kanayama K, Sankai T, Yasutomi Y, Ageyama N. 2020. Establishment of a new formula for QT interval correction using a large colony of cynomolgus monkeys. Exp Anim. 69(1):18–25.
   PubMed Web of Science ®Google Scholar
• Patel S, Bhatt L, Patel R, Shah C, Patel V, Patel J, Sundar R, Bhatnagar U, Jain M. 2017. Identification of appropriate QTc formula in beagle dogs for nonclinical safety assessment. Regul Toxicol Pharmacol. 89:118–124.
   PubMed Web of Science ®Google Scholar
• Porsolt RD, Picard S, Lacroix P. 2005. International safety pharmacology guidelines (ICH S7A and S7B): where do we go from here? Drug Dev Res. 64(2):83–89.
   Web of Science ®Google Scholar
• Rabkin SW, Cheng XB. 2015. Nomenclature, categorization and usage of formulae to adjust QT interval for heart rate. World J Cardiol. 7(6):315–325.
   PubMed Web of Science ®Google Scholar
• Rautaharju PM, Zhang ZM. 2002. Linearly scaled, rate-invariant normal limits for QT interval: eight decades of incorrect application of power functions. J Cardiovasc Electrophysiol. 13(12):1211–1218.
   PubMed Web of Science ®Google Scholar
• Richig J, Sleeper M. 2018. Electrocardiography of laboratory animals. 2nd ed. Cambridge (MA): Academic Press.
   Google Scholar
• Sagie A, Larson MG, Goldberg RJ, Bengtson JR, Levy D. 1992. An improved method for adjusting the QT interval for heart rate (the Framingham Heart Study). Am J Cardiol. 70(7):797–801.
   PubMed Web of Science ®Google Scholar
• Shah NA, Bhatt LK, Patel RJ, Patel TM, Patel NV, Trivedi HG, Patel NR, Patel JH, Patel SD, Sundar RS, et al. 2022. Hematological and biochemical reference intervals of wild-caught and inhouse adult Indian rhesus macaques (Macaca mulatta). Lab Anim Res. 38(1):1–9.
   PubMed Web of Science ®Google Scholar
• Simmons HA. 2016. Age-associated pathology in rhesus macaques (Macaca mulatta). Vet Pathol. 53(2):399–416.
   PubMed Web of Science ®Google Scholar
• Tattersall ML, Dymond M, Hammond T, Valentin JP. 2006. Correction of QT values to allow for increases in heart rate in conscious Beagle dogs in toxicology assessment. J Pharmacol Toxicol Methods. 53(1):11–19.
   PubMedGoogle Scholar
• Van de Water A, Verheyen J, Xhonneux R, Reneman RS. 1989. An improved method to correct the QT interval of the electrocardiogram for changes in heart rate. J Pharmacol Methods. 22(3):207–217.
   PubMedGoogle Scholar
• Vandenberk B, Vandael E, Robyns T, Vandenberghe J, Garweg C, Foulon V, Ector J, Willems R. 2016. Which QT correction formulae to use for QT monitoring? J Am Heart Assoc. 5(6):e003264. Erratum in: J Am Heart Assoc. 2018 Aug 21;7(16):e004252.
   PubMed Web of Science ®Google Scholar
• Yap YG, Camm AJ. 2003. Drug induced QT prolongation and torsades de pointes. Heart. 89(11):1363–1372.
   PubMed Web of Science ®Google Scholar