Drug-induced QT interval prolongation: does ethnicity of the thorough QT study population matter?

ABSTRACT: Inter-ethnic differences in drug responses have been well documented. Drug-induced QT interval prolongation is a major safety concern and therefore, regulatory authorities recommend a clinical thorough QT study (TQT) to investigate new drugs for their QT-prolonging potential. A positive study, determined by breach of a preset regulatory threshold, significantly influences late phase clinical trials by requiring intense ECG monitoring. A few studies that are currently available, although not statistically conclusive at present, question the assumption that ethnicity of the study population may not influence the outcome of a TQT study. Collective consideration of available pharmacogenetic and clinical information suggests that there may be inter-ethnic differences in QT-prolonging effects of

SUBMITTER: Shah RR 

PROVIDER: S-EPMC3579250 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature