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Effect of hydroxychloroquine on the cardiac ventricular repolarization: A randomized clinical trial.
Eveleens Maarse, Boukje C; Graff, Claus; Kanters, Jørgen K; van Esdonk, Michiel J; Kemme, Michiel J B; In 't Veld, Aliede E; Jansen, Manon A A; Moerland, Matthijs; Gal, Pim.
  • Eveleens Maarse BC; Centre for Human Drug Research, Leiden, The Netherlands.
  • Graff C; Leiden University Medical Centre, Leiden, The Netherlands.
  • Kanters JK; Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
  • van Esdonk MJ; Laboratory of Experimental Cardiology, University of Copenhagen, Copenhagen, Denmark.
  • Kemme MJB; Centre for Human Drug Research, Leiden, The Netherlands.
  • In 't Veld AE; Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.
  • Jansen MAA; Centre for Human Drug Research, Leiden, The Netherlands.
  • Moerland M; Leiden University Medical Centre, Leiden, The Netherlands.
  • Gal P; Centre for Human Drug Research, Leiden, The Netherlands.
Br J Clin Pharmacol ; 88(3): 1054-1062, 2022 03.
Article in English | MEDLINE | ID: covidwho-1334431
ABSTRACT

AIMS:

Hydroxychloroquine has been suggested as possible treatment for severe acute respiratory syndrome-coronavirus-2. Studies reported an increased risk of QTcF-prolongation after treatment with hydroxychloroquine. The aim of this study was to analyse the concentration-dependent effects of hydroxychloroquine on the ventricular repolarization, including QTcF-duration and T-wave morphology.

METHODS:

Twenty young (≤30 y) and 20 elderly (65-75 y) healthy male subjects were included. Subjects were randomized to receive either a total dose of 2400 mg hydroxychloroquine over 5 days, or placebo (ratio 11). Follow-up duration was 28 days. Electrocardiograms (ECGs) were recorded as triplicate at baseline and 4 postdose single recordings, followed by hydroxychloroquine concentration measurements. ECG intervals (RR, QRS, PR, QTcF, J-Tpc, Tp-Te) and T-wave morphology, measured with the morphology combination score, were analysed with a prespecified linear mixed effects concentration-effect model.

RESULTS:

There were no significant associations between hydroxychloroquine concentrations and ECG characteristics, including RR-, QRS- and QTcF-interval (P = .09, .34, .25). Mean ΔΔQTcF-interval prolongation did not exceed 5 ms and the upper limit of the 90% confidence interval did not exceed 10 ms at the highest measured concentrations (200 ng/mL). There were no associations between hydroxychloroquine concentration and the T-wave morphology (P = .34 for morphology combination score). There was no significant effect of age group on ECG characteristics.

CONCLUSION:

In this study, hydroxychloroquine did not affect ventricular repolarization, including the QTcF-interval and T-wave morphology, at plasma concentrations up to 200 ng/mL. Based on this analysis, hydroxychloroquine does not appear to increase the risk of QTcF-induced arrhythmias.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Long QT Syndrome / COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Aged / Humans / Male Language: English Journal: Br J Clin Pharmacol Year: 2022 Document Type: Article Affiliation country: Bcp.15013

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Long QT Syndrome / COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Aged / Humans / Male Language: English Journal: Br J Clin Pharmacol Year: 2022 Document Type: Article Affiliation country: Bcp.15013