American College of Clinical Pharmacology® & Cardiac Safety Research Consortium are pleased to announce the publication of their first co-authored paper, "The Potential Role of the J-Tpeak Interval in Pro-arrhythmic Cardiac Safety − Current State-of-the-Science from the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium," in The Journal of Clinical Pharmacology.
Read the Position Paper here.
Dr. Michael J. Fossler, Jr. emphasized, "This important paper demonstrates the potential value of the J-Tpeak interval, which may be a more discerning marker of pro-arrhythmic potential than the QTc interval. Very soon, new drug developers may be able to use this technique to develop safer pharmaceuticals for patients. Also highlighted is the value of research consortiums & regulatory agencies collaborating to find solutions to difficult regulatory issues."
Sudden death resulting from drug-induced proarrhythmia is one of the most feared complications in pharmaceutical medicine and, accordingly, regulatory landscapes are now in place to investigate a new drug's proarrhythmic liability before marketing approval. Following initial assessments during nonclinical investigations, evaluation during clinical pharmacology studies is of fundamental importance. Since 2005, these studies have focused on the use of the heart rate-corrected QT interval as seen on the human electrocardiogram (ECG) for purposes of evaluating a new drug's potential to induce Torsade de Pointes. Torsade is a rare polymorphic ventricular arrhythmia that typically occurs in self-limiting bursts that can lead to symptoms of dizziness, palpitations, syncope and seizures, but that can also occasionally progress to ventricular fibrillation and sudden cardiac death. To date, QT interval prolongation has been considered to be an imperfect but nonetheless informative proarrhythmic liability biomarker.
More recently, attention has focused on another ECG interval, the heart rate-corrected J-Tpeak interval, hoping that it may prove to be a more discerning biomarker of true proarrhythmic liability. Accordingly, this manuscript introduces readers to the J-Tpeak interval, explains what it is and why it is important, provides initial evidence of its usefulness in the identification of true proarrhythmic liability and outlines additional activities necessary to further substantiate its clinical, scientific and regulatory relevance.
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