Considerations for assessing the potential effects of antidiabetes drugs on cardiac ventricular repolarization: A report from the Cardiac Safety Research Consortium

Thorough QT studies conducted according to the International Council on Harmonisation E14 guideline are required for new nonantiarrhythmic drugs to assess the potential to prolong ventricular repolarization. Special considerations may be needed for conducting such studies with antidiabetes drugs as...

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Veröffentlicht in:	The American heart journal 2015-07, Vol.170 (1), p.23-35
Hauptverfasser:	Heller, Simon, FRCP, Darpö, Börje, MD, PhD, Mitchell, Malcolm I., MBBS, MFPM, Linnebjerg, Helle, PhD, Leishman, Derek J., PhD, DSP, Mehrotra, Nitin, PhD, Zhu, Hao, PhD, Koerner, John, PhD, Fiszman, Mónica L., MD, PhD, Balakrishnan, Suchitra, MD, PhD, Xiao, Shen, MD, PhD, Todaro, Thomas G., MD, JD, Hensley, Ingrid, PhD, Guth, Brian D., PhD, Michelson, Eric L., MD, FACC, Sager, Philip, MD, FACC, FAHA, FHRS
Format:	Artikel
Sprache:	eng
Schlagworte:	Arrhythmias, Cardiac - chemically induced Brugada Syndrome Cardiac arrhythmia Cardiac Conduction System Disease Cardiovascular Dipeptidyl-Peptidase IV Inhibitors - adverse effects Electrocardiography Glucagon-Like Peptide-1 Receptor Glucose Glycoside Hydrolase Inhibitors Heart Conduction System - abnormalities Heart Ventricles Humans Hyperglycemia Hypoglycemic Agents - adverse effects Insulin Long QT Syndrome - chemically induced Patch-Clamp Techniques Receptors, Glucagon - agonists Sodium-Glucose Transporter 2 Inhibitors Sulfonylurea Compounds - adverse effects Thiazolidinediones - adverse effects Ventricular Function
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Zusammenfassung:	Thorough QT studies conducted according to the International Council on Harmonisation E14 guideline are required for new nonantiarrhythmic drugs to assess the potential to prolong ventricular repolarization. Special considerations may be needed for conducting such studies with antidiabetes drugs as changes in blood glucose and other physiologic parameters affected by antidiabetes drugs may prolong the QT interval and thus confound QT/corrected QT assessments. This review discusses potential mechanisms for QT/corrected QT interval prolongation with antidiabetes drugs and offers practical considerations for assessing antidiabetes drugs in thorough QT studies. This article represents collaborative discussions among key stakeholders from academia, industry, and regulatory agencies participating in the Cardiac Safety Research Consortium. It does not represent regulatory policy.
ISSN:	0002-8703 1097-6744
DOI:	10.1016/j.ahj.2015.03.007