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KMID : 1142220150100010039
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Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 1 p.39 ~ p.46
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Points to Consider During the Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Risk for New Drug Approval in the Republic of Korea
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Yun Jae-Suk
Hwangbo Eun
Lee Jong-Pill
Seo Hyun-Ok
Lim Hwa-Kyung
Park Man-Young
Park Rae-Woong
Choi Don-Woong
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Abstract
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A number of non-antiarrhythmic drugs have been shown to delay cardiac repolarization, an undesirable effect that can be detected as a prolongation of the QT interval on surface electrocardiogram (ECG). The ICH E14 guidance was approved by the steering committee of ICH under step4 in May 2005 and addresses the liability of new drugs to induce such prolongation. The ‘thorough QT/QTc study’ described in the guidance is recommended to positively identify drugs that may cause QT prolongation issues. Based on these efforts, we sought to develop a Korean version of the guidance appropriate for the clinical evaluation of QT/QTc interval prolongation and the proarrhythmic potential of novel drug candidates in the Republic of Korea. We suggest a number of points to consider for clinical trials in the Korean population such as QTc correction, positive control, baseline of Korean ECG parameters, and have conducted an ECG database (ECG ViEW) analysis to identify the mean QT/QTc intervals for both healthy individuals and patients with risk factors (e.g. hypokalemia). Our findings provide guidance for the testing of drugs of potential concern with regards to ICH E14 in the Korean population.
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KEYWORD
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QT prolongation, ICH E14, Safety pharmacology, Drug devel
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