Key result
Omitting QT/RR hysteresis correction increased the width of the confidence intervals of PK/PD predicted QTc interval changes by 19.0% to 28.1%, which may lead to missed signals of QTc prolongation.
Why the study?
Does incorporating QT/RR hysteresis correction improve the accuracy of drug-induced QTc interval changes compared to omitting it?
Does incorporating QT/RR hysteresis correction improve the accuracy of drug-induced QTc interval changes compared to omitting it?
Effect estimate: 19.0% to 28.1% increase
p-value: p=<0.0001
Correction for QT/RR hysteresis should be incorporated into future studies of drug-induced QTc changes to decrease confidence intervals and avoid false positive outcomes.
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May bias QTc precision in TQT studies; hypothesis-generating for routine hysteresis inclusion.
Malík et al. (2018) studied Healthy subjects (n=751). QT/RR hysteresis correction vs. Omission of QT/RR hysteresis correction was evaluated on Width of confidence intervals of DDQTc estimates (19.0% to 28.1% increase, p=<0.0001). Omitting QT/RR hysteresis correction increased the width of the confidence intervals of PK/PD predicted QTc interval changes by 19.0% to 28.1%, which may lead to missed signals of QTc prolongation.
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