Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database.
Identifieur interne : 000637 ( Main/Corpus ); précédent : 000636; suivant : 000638Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database.
Auteurs : Alexandre O. Gérard ; Audrey Laurain ; Audrey Fresse ; Nadège Parassol ; Marine Muzzone ; Fanny Rocher ; Vincent L M. Esnault ; Milou-Daniel DriciSource :
- Clinical pharmacology and therapeutics [ 1532-6535 ] ; 2021.
English descriptors
- KwdEn :
- Acute Kidney Injury (chemically induced), Adenosine Monophosphate (adverse effects), Adenosine Monophosphate (analogs & derivatives), Adenosine Monophosphate (therapeutic use), Alanine (adverse effects), Alanine (analogs & derivatives), Alanine (therapeutic use), Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), COVID-19 (drug therapy), Humans (MeSH), Odds Ratio (MeSH), Pharmacovigilance (MeSH), SARS-CoV-2 (MeSH), World Health Organization (MeSH).
- MESH :
- chemical , adverse effects : Adenosine Monophosphate, Alanine, Antiviral Agents.
- chemical , analogs & derivatives : Adenosine Monophosphate, Alanine.
- chemically induced : Acute Kidney Injury.
- drug therapy : COVID-19.
- chemical , therapeutic use : Adenosine Monophosphate, Alanine, Antiviral Agents.
- Humans, Odds Ratio, Pharmacovigilance, SARS-CoV-2, World Health Organization.
Abstract
Remdesivir is approved for emergency use by the US Food and Drug Administration (FDA) and authorized conditionally by the European Medicines Agency (EMA) for patients with coronavirus disease 2019 (COVID-19). Its benefit-risk ratio is still being explored because data in the field are rather scant. A decrease of the creatinine clearance associated with remdesivir has been inconstantly reported in clinical trials with unclear relevance. Despite these uncertainties, we searched for a potential signal of acute renal failure (ARF) in pharmacovigilance postmarketing data. An analysis of the international pharmacovigilance postmarketing databases (VigiBase) of the World Health Organization (WHO) was performed, using two disproportionality methods. Reporting odds ratio (ROR) compared the number of ARF cases reported with remdesivir, with those reported with other drugs prescribed in comparable situations of COVID-19 (hydroxychloroquine, tocilizumab, and lopinavir/ritonavir). The combination of the terms "acute renal failure" and "remdesivir" yielded a statistically significant disproportionality signal with 138 observed cases instead of the 9 expected. ROR of ARF with remdesivir was 20-fold (20.3; confidence interval 0.95 [15.7-26.3], P < 0.0001]) that of comparative drugs. Based on ARF cases reported in VigiBase, and despite the caveats inherent to COVID-19 circumstances, we detected a statistically significant pharmacovigilance signal of nephrotoxicity associated with remdesivir, deserving a thorough qualitative assessment of all available data. Meanwhile, as recommended in its Summary of Product Characteristics, assessment of patients with COVID-19 renal function should prevail before and during treatment with remdesivir in COVID-19.
DOI: 10.1002/cpt.2145
PubMed: 33340409
Links to Exploration step
pubmed:33340409Le document en format XML
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Gérard</name><affiliation><nlm:affiliation>Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Laurain, Audrey" sort="Laurain, Audrey" uniqKey="Laurain A" first="Audrey" last="Laurain">Audrey Laurain</name><affiliation><nlm:affiliation>Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Fresse, Audrey" sort="Fresse, Audrey" uniqKey="Fresse A" first="Audrey" last="Fresse">Audrey Fresse</name><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Parassol, Nadege" sort="Parassol, Nadege" uniqKey="Parassol N" first="Nadège" last="Parassol">Nadège Parassol</name><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Muzzone, Marine" sort="Muzzone, Marine" uniqKey="Muzzone M" first="Marine" last="Muzzone">Marine Muzzone</name><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Rocher, Fanny" sort="Rocher, Fanny" uniqKey="Rocher F" first="Fanny" last="Rocher">Fanny Rocher</name><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Esnault, Vincent L M" sort="Esnault, Vincent L M" uniqKey="Esnault V" first="Vincent L M" last="Esnault">Vincent L M. 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Gérard</name><affiliation><nlm:affiliation>Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Laurain, Audrey" sort="Laurain, Audrey" uniqKey="Laurain A" first="Audrey" last="Laurain">Audrey Laurain</name><affiliation><nlm:affiliation>Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Fresse, Audrey" sort="Fresse, Audrey" uniqKey="Fresse A" first="Audrey" last="Fresse">Audrey Fresse</name><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Parassol, Nadege" sort="Parassol, Nadege" uniqKey="Parassol N" first="Nadège" last="Parassol">Nadège Parassol</name><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Muzzone, Marine" sort="Muzzone, Marine" uniqKey="Muzzone M" first="Marine" last="Muzzone">Marine Muzzone</name><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Rocher, Fanny" sort="Rocher, Fanny" uniqKey="Rocher F" first="Fanny" last="Rocher">Fanny Rocher</name><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Esnault, Vincent L M" sort="Esnault, Vincent L M" uniqKey="Esnault V" first="Vincent L M" last="Esnault">Vincent L M. Esnault</name><affiliation><nlm:affiliation>Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author><author><name sortKey="Drici, Milou Daniel" sort="Drici, Milou Daniel" uniqKey="Drici M" first="Milou-Daniel" last="Drici">Milou-Daniel Drici</name><affiliation><nlm:affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Clinical pharmacology and therapeutics</title><idno type="eISSN">1532-6535</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acute Kidney Injury (chemically induced)</term><term>Adenosine Monophosphate (adverse effects)</term><term>Adenosine Monophosphate (analogs & derivatives)</term><term>Adenosine Monophosphate (therapeutic use)</term><term>Alanine (adverse effects)</term><term>Alanine (analogs & derivatives)</term><term>Alanine (therapeutic use)</term><term>Antiviral Agents (adverse effects)</term><term>Antiviral Agents (therapeutic use)</term><term>COVID-19 (drug therapy)</term><term>Humans (MeSH)</term><term>Odds Ratio (MeSH)</term><term>Pharmacovigilance (MeSH)</term><term>SARS-CoV-2 (MeSH)</term><term>World Health Organization (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Adenosine Monophosphate</term><term>Alanine</term><term>Antiviral Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Adenosine Monophosphate</term><term>Alanine</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Acute Kidney Injury</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Adenosine Monophosphate</term><term>Alanine</term><term>Antiviral Agents</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>Odds Ratio</term><term>Pharmacovigilance</term><term>SARS-CoV-2</term><term>World Health Organization</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Remdesivir is approved for emergency use by the US Food and Drug Administration (FDA) and authorized conditionally by the European Medicines Agency (EMA) for patients with coronavirus disease 2019 (COVID-19). Its benefit-risk ratio is still being explored because data in the field are rather scant. A decrease of the creatinine clearance associated with remdesivir has been inconstantly reported in clinical trials with unclear relevance. Despite these uncertainties, we searched for a potential signal of acute renal failure (ARF) in pharmacovigilance postmarketing data. An analysis of the international pharmacovigilance postmarketing databases (VigiBase) of the World Health Organization (WHO) was performed, using two disproportionality methods. Reporting odds ratio (ROR) compared the number of ARF cases reported with remdesivir, with those reported with other drugs prescribed in comparable situations of COVID-19 (hydroxychloroquine, tocilizumab, and lopinavir/ritonavir). The combination of the terms "acute renal failure" and "remdesivir" yielded a statistically significant disproportionality signal with 138 observed cases instead of the 9 expected. ROR of ARF with remdesivir was 20-fold (20.3; confidence interval 0.95 [15.7-26.3], P < 0.0001]) that of comparative drugs. Based on ARF cases reported in VigiBase, and despite the caveats inherent to COVID-19 circumstances, we detected a statistically significant pharmacovigilance signal of nephrotoxicity associated with remdesivir, deserving a thorough qualitative assessment of all available data. Meanwhile, as recommended in its Summary of Product Characteristics, assessment of patients with COVID-19 renal function should prevail before and during treatment with remdesivir in COVID-19.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33340409</PMID><DateCompleted><Year>2021</Year><Month>04</Month><Day>14</Day></DateCompleted><DateRevised><Year>2021</Year><Month>04</Month><Day>14</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1532-6535</ISSN><JournalIssue CitedMedium="Internet"><Volume>109</Volume><Issue>4</Issue><PubDate><Year>2021</Year><Month>04</Month></PubDate></JournalIssue><Title>Clinical pharmacology and therapeutics</Title><ISOAbbreviation>Clin Pharmacol Ther</ISOAbbreviation></Journal><ArticleTitle>Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database.</ArticleTitle><Pagination><MedlinePgn>1021-1024</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/cpt.2145</ELocationID><Abstract><AbstractText>Remdesivir is approved for emergency use by the US Food and Drug Administration (FDA) and authorized conditionally by the European Medicines Agency (EMA) for patients with coronavirus disease 2019 (COVID-19). Its benefit-risk ratio is still being explored because data in the field are rather scant. A decrease of the creatinine clearance associated with remdesivir has been inconstantly reported in clinical trials with unclear relevance. Despite these uncertainties, we searched for a potential signal of acute renal failure (ARF) in pharmacovigilance postmarketing data. An analysis of the international pharmacovigilance postmarketing databases (VigiBase) of the World Health Organization (WHO) was performed, using two disproportionality methods. Reporting odds ratio (ROR) compared the number of ARF cases reported with remdesivir, with those reported with other drugs prescribed in comparable situations of COVID-19 (hydroxychloroquine, tocilizumab, and lopinavir/ritonavir). The combination of the terms "acute renal failure" and "remdesivir" yielded a statistically significant disproportionality signal with 138 observed cases instead of the 9 expected. ROR of ARF with remdesivir was 20-fold (20.3; confidence interval 0.95 [15.7-26.3], P < 0.0001]) that of comparative drugs. Based on ARF cases reported in VigiBase, and despite the caveats inherent to COVID-19 circumstances, we detected a statistically significant pharmacovigilance signal of nephrotoxicity associated with remdesivir, deserving a thorough qualitative assessment of all available data. Meanwhile, as recommended in its Summary of Product Characteristics, assessment of patients with COVID-19 renal function should prevail before and during treatment with remdesivir in COVID-19.</AbstractText><CopyrightInformation>© 2020 The Authors. Clinical Pharmacology & Therapeutics © 2020 American Society for Clinical Pharmacology and Therapeutics.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gérard</LastName><ForeName>Alexandre O</ForeName><Initials>AO</Initials><AffiliationInfo><Affiliation>Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Laurain</LastName><ForeName>Audrey</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fresse</LastName><ForeName>Audrey</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Parassol</LastName><ForeName>Nadège</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Muzzone</LastName><ForeName>Marine</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rocher</LastName><ForeName>Fanny</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Esnault</LastName><ForeName>Vincent L M</ForeName><Initials>VLM</Initials><AffiliationInfo><Affiliation>Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Drici</LastName><ForeName>Milou-Daniel</ForeName><Initials>MD</Initials><AffiliationInfo><Affiliation>Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>01</Month><Day>16</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Pharmacol Ther</MedlineTA><NlmUniqueID>0372741</NlmUniqueID><ISSNLinking>0009-9236</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>3QKI37EEHE</RegistryNumber><NameOfSubstance UI="C000606551">remdesivir</NameOfSubstance></Chemical><Chemical><RegistryNumber>415SHH325A</RegistryNumber><NameOfSubstance UI="D000249">Adenosine Monophosphate</NameOfSubstance></Chemical><Chemical><RegistryNumber>OF5P57N2ZX</RegistryNumber><NameOfSubstance UI="D000409">Alanine</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D058186" MajorTopicYN="N">Acute Kidney Injury</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000249" MajorTopicYN="N">Adenosine Monophosphate</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000409" MajorTopicYN="N">Alanine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000998" MajorTopicYN="N">Antiviral Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016017" MajorTopicYN="N">Odds Ratio</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D060735" MajorTopicYN="N">Pharmacovigilance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014944" MajorTopicYN="N">World Health Organization</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>10</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>12</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>12</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>4</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>12</Month><Day>19</Day><Hour>17</Hour><Minute>3</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33340409</ArticleId><ArticleId IdType="doi">10.1002/cpt.2145</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Jorgensen, S.C.J., Kebriaei, R. & Dresser, L.D. 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