Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine.
Identifieur interne : 000149 ( Main/Exploration ); précédent : 000148; suivant : 000150Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine.
Auteurs : Amir Sarayani [États-Unis] ; Brian Cicali [États-Unis] ; Carl H. Henriksen [États-Unis] ; Joshua D. Brown [États-Unis]Source :
- Research in social & administrative pharmacy : RSAP [ 1934-8150 ] ; 2021.
Descripteurs français
- KwdFr :
- Antiviraux (effets indésirables), Antiviraux (usage thérapeutique), Association de médicaments (MeSH), Azithromycine (effets indésirables), Azithromycine (usage thérapeutique), Chloroquine (effets indésirables), Chloroquine (usage thérapeutique), Humains (MeSH), Hydroxychloroquine (effets indésirables), Hydroxychloroquine (usage thérapeutique), Interactions médicamenteuses (MeSH), Pharmacovigilance (MeSH), Syndrome du QT long (induit chimiquement), Syndrome du QT long (mortalité), Torsades de pointes (induit chimiquement), Torsades de pointes (mortalité), États-Unis (épidémiologie).
- MESH :
- effets indésirables : Antiviraux, Azithromycine, Chloroquine, Hydroxychloroquine.
- induit chimiquement : Syndrome du QT long, Torsades de pointes.
- mortalité : Syndrome du QT long, Torsades de pointes.
- usage thérapeutique : Antiviraux, Azithromycine, Chloroquine, Hydroxychloroquine.
- épidémiologie : États-Unis.
- Association de médicaments, Humains, Interactions médicamenteuses, Pharmacovigilance.
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Azithromycin (adverse effects), Azithromycin (therapeutic use), COVID-19 (complications), COVID-19 (drug therapy), Chloroquine (adverse effects), Chloroquine (therapeutic use), Drug Interactions (MeSH), Drug Therapy, Combination (MeSH), Humans (MeSH), Hydroxychloroquine (adverse effects), Hydroxychloroquine (therapeutic use), Long QT Syndrome (chemically induced), Long QT Syndrome (mortality), Pharmacovigilance (MeSH), Torsades de Pointes (chemically induced), Torsades de Pointes (mortality), United States (epidemiology).
- MESH :
- chemical , adverse effects : Antiviral Agents, Azithromycin, Chloroquine, Hydroxychloroquine.
- chemical , therapeutic use : Antiviral Agents, Azithromycin, Chloroquine, Hydroxychloroquine.
- geographic , epidemiology : United States.
- chemically induced : Long QT Syndrome, Torsades de Pointes.
- complications : COVID-19.
- drug therapy : COVID-19.
- mortality : Long QT Syndrome, Torsades de Pointes.
- Drug Interactions, Drug Therapy, Combination, Humans, Pharmacovigilance.
Abstract
Background
Combinations of hydroxychloroquine (HCQ) and azithromycin have been promoted as treatments for COVID-19 based on small, uncontrolled clinical trials that have not assessed potential risks. Risks of treatment include QT segment prolongation, Torsades de Pointes (TdP), and death. This comparative pharmacovigilance analysis evaluated the risk of these events.
Methods
Data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) (>13 million total reports) were used. Queries extracted reports based on exposures of HCQ/chloroquine (CQ) alone, azithromycin alone, HCQ/CQ + azithromycin, amoxicillin alone, HCQ/CQ + amoxicillin alone. Amoxicillin served as a control. Events of interest included death and TdP/QT prolongation as well as accidents/injuries and depression as control events. Proportional Reporting Ratios (PRR) and 95% confidence intervals (CI) were calculated where a lower limit of the of 95% CI (Lower95CI) value of ≥2.0 is interpreted as a potential safety signal.
Results
Lower95CIs for HCQ/CQ alone showed no potential safety signals for TdP/QT prolongation, death, or any of the control events included. The PRRs and 95% CIs for TdP/QT prolongation was 1.43 (1.29-2.59) with HCQ/CQ use alone and 4.10 (3.80-4.42) for azithromycin alone. For the combined HCQ/CQ + azithromycin group, the PRR and 95% CI was 3.77 (1.80-7.87). For the control of amoxicillin, there were no safety signals when used alone or in combination with HCQ/CQ.
Conclusions
HCQ/CQ use was not associated with a safety signal in this analysis of FAERS data. However, azithromycin used alone was associated with TdP/QT prolongation events and should be used with caution.
DOI: 10.1016/j.sapharm.2020.04.016
PubMed: 32327397
PubMed Central: PMC7166303
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral Agents (adverse effects)</term>
<term>Antiviral Agents (therapeutic use)</term>
<term>Azithromycin (adverse effects)</term>
<term>Azithromycin (therapeutic use)</term>
<term>COVID-19 (complications)</term>
<term>COVID-19 (drug therapy)</term>
<term>Chloroquine (adverse effects)</term>
<term>Chloroquine (therapeutic use)</term>
<term>Drug Interactions (MeSH)</term>
<term>Drug Therapy, Combination (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (adverse effects)</term>
<term>Hydroxychloroquine (therapeutic use)</term>
<term>Long QT Syndrome (chemically induced)</term>
<term>Long QT Syndrome (mortality)</term>
<term>Pharmacovigilance (MeSH)</term>
<term>Torsades de Pointes (chemically induced)</term>
<term>Torsades de Pointes (mortality)</term>
<term>United States (epidemiology)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Antiviraux (effets indésirables)</term>
<term>Antiviraux (usage thérapeutique)</term>
<term>Association de médicaments (MeSH)</term>
<term>Azithromycine (effets indésirables)</term>
<term>Azithromycine (usage thérapeutique)</term>
<term>Chloroquine (effets indésirables)</term>
<term>Chloroquine (usage thérapeutique)</term>
<term>Humains (MeSH)</term>
<term>Hydroxychloroquine (effets indésirables)</term>
<term>Hydroxychloroquine (usage thérapeutique)</term>
<term>Interactions médicamenteuses (MeSH)</term>
<term>Pharmacovigilance (MeSH)</term>
<term>Syndrome du QT long (induit chimiquement)</term>
<term>Syndrome du QT long (mortalité)</term>
<term>Torsades de pointes (induit chimiquement)</term>
<term>Torsades de pointes (mortalité)</term>
<term>États-Unis (épidémiologie)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term>
<term>Azithromycin</term>
<term>Chloroquine</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term>
<term>Azithromycin</term>
<term>Chloroquine</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>United States</term>
</keywords>
<keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Long QT Syndrome</term>
<term>Torsades de Pointes</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>COVID-19</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antiviraux</term>
<term>Azithromycine</term>
<term>Chloroquine</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" qualifier="induit chimiquement" xml:lang="fr"><term>Syndrome du QT long</term>
<term>Torsades de pointes</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Long QT Syndrome</term>
<term>Torsades de Pointes</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Syndrome du QT long</term>
<term>Torsades de pointes</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antiviraux</term>
<term>Azithromycine</term>
<term>Chloroquine</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>États-Unis</term>
</keywords>
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<term>Drug Therapy, Combination</term>
<term>Humans</term>
<term>Pharmacovigilance</term>
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<term>Humains</term>
<term>Interactions médicamenteuses</term>
<term>Pharmacovigilance</term>
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<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</term>
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<front><div type="abstract" xml:lang="en"><p><b>Background</b>
</p>
<p>Combinations of hydroxychloroquine (HCQ) and azithromycin have been promoted as treatments for COVID-19 based on small, uncontrolled clinical trials that have not assessed potential risks. Risks of treatment include QT segment prolongation, Torsades de Pointes (TdP), and death. This comparative pharmacovigilance analysis evaluated the risk of these events.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>Methods</b>
</p>
<p>Data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) (>13 million total reports) were used. Queries extracted reports based on exposures of HCQ/chloroquine (CQ) alone, azithromycin alone, HCQ/CQ + azithromycin, amoxicillin alone, HCQ/CQ + amoxicillin alone. Amoxicillin served as a control. Events of interest included death and TdP/QT prolongation as well as accidents/injuries and depression as control events. Proportional Reporting Ratios (PRR) and 95% confidence intervals (CI) were calculated where a lower limit of the of 95% CI (Lower95CI) value of ≥2.0 is interpreted as a potential safety signal.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>Results</b>
</p>
<p>Lower95CIs for HCQ/CQ alone showed no potential safety signals for TdP/QT prolongation, death, or any of the control events included. The PRRs and 95% CIs for TdP/QT prolongation was 1.43 (1.29-2.59) with HCQ/CQ use alone and 4.10 (3.80-4.42) for azithromycin alone. For the combined HCQ/CQ + azithromycin group, the PRR and 95% CI was 3.77 (1.80-7.87). For the control of amoxicillin, there were no safety signals when used alone or in combination with HCQ/CQ.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>Conclusions</b>
</p>
<p>HCQ/CQ use was not associated with a safety signal in this analysis of FAERS data. However, azithromycin used alone was associated with TdP/QT prolongation events and should be used with caution.</p>
</div>
</front>
</TEI>
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<Abstract><AbstractText Label="Background">Combinations of hydroxychloroquine (HCQ) and azithromycin have been promoted as treatments for COVID-19 based on small, uncontrolled clinical trials that have not assessed potential risks. Risks of treatment include QT segment prolongation, Torsades de Pointes (TdP), and death. This comparative pharmacovigilance analysis evaluated the risk of these events.</AbstractText>
<AbstractText Label="Methods">Data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) (>13 million total reports) were used. Queries extracted reports based on exposures of HCQ/chloroquine (CQ) alone, azithromycin alone, HCQ/CQ + azithromycin, amoxicillin alone, HCQ/CQ + amoxicillin alone. Amoxicillin served as a control. Events of interest included death and TdP/QT prolongation as well as accidents/injuries and depression as control events. Proportional Reporting Ratios (PRR) and 95% confidence intervals (CI) were calculated where a lower limit of the of 95% CI (Lower95CI) value of ≥2.0 is interpreted as a potential safety signal.</AbstractText>
<AbstractText Label="Results">Lower95CIs for HCQ/CQ alone showed no potential safety signals for TdP/QT prolongation, death, or any of the control events included. The PRRs and 95% CIs for TdP/QT prolongation was 1.43 (1.29-2.59) with HCQ/CQ use alone and 4.10 (3.80-4.42) for azithromycin alone. For the combined HCQ/CQ + azithromycin group, the PRR and 95% CI was 3.77 (1.80-7.87). For the control of amoxicillin, there were no safety signals when used alone or in combination with HCQ/CQ.</AbstractText>
<AbstractText Label="Conclusions">HCQ/CQ use was not associated with a safety signal in this analysis of FAERS data. However, azithromycin used alone was associated with TdP/QT prolongation events and should be used with caution.</AbstractText>
<CopyrightInformation>© 2020 Elsevier Inc. All rights reserved.</CopyrightInformation>
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<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sarayani</LastName>
<ForeName>Amir</ForeName>
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</AffiliationInfo>
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</AffiliationInfo>
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<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
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<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
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<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
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<MeshHeading><DescriptorName UI="D016171" MajorTopicYN="N">Torsades de Pointes</DescriptorName>
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<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
</MeshHeading>
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