The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development

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• 作者：Adel Nada ; MD ; MS ; MFPM^a ; ^{adel_nada@baxter.com} ; Gary A. Gintant ; PhD^b ; Robert Kleiman ; MD^c ; David E. Gutstein ; MD^d ; Christer Gottfridsson ; MD ; PhD^e ; Eric L. Michelson ; MD^f ; Colette Strnadova ; PhD^g ; Matthew Killeen ; MD^h ; Mary Jane Geiger ; MD ; PhDⁱ ; Mó ; nica L. Fiszman ; MD ; PhD^j ; Luana Pesco Koplowitz ; MD^k ; Glenn F. Carlson ; MD^f ; Ignacio Rodriguez ; MD^l ; Philip T. Sager ; MD^m
• 刊名：American Heart Journal
• 出版年：2013
• 出版时间：April, 2013
• 年：2013
• 卷：165
• 期：4
• 页码：489-500
• 全文大小：379 K

文摘

Recent advances in electrocardiographic monitoring and waveform analysis have significantly improved the ability to detect drug-induced changes in cardiac repolarization manifested as changes in the QT/corrected QT interval. These advances have also improved the ability to detect drug-induced changes in cardiac conduction. This White Paper summarizes current opinion, reached by consensus among experts at the Cardiac Safety Research Consortium, on the assessment of electrocardiogram-based safety measurements of the PR and QRS intervals, representing atrioventricular and ventricular conduction, respectively, during drug development.