Exposure-safety analysis of QTc interval and transaminase levels following bedaquiline administration in patients with drug-resistant tuberculosis.

CPT Pharmacometrics Syst Pharmacol · 2021 · PMC8674006 · PMID 34626526

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a positive trendno p-value reported

BDQ’s main metabolite (M2) levels were found to significantly correlate with QTcF prolongation, whereas only a positive trend (nonsignificant positive correlation) was observed with BDQ concentrations. 7 , 8 In the Nix‐TB trial ( NCT02333799 ), where BDQ was administered in a combination therapy, the effect of M2 concentrations on QTc interval was described by a linear model. 9 Besides the potential effects of

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