{"id":82878,"date":"2021-09-06T09:16:44","date_gmt":"2021-09-06T13:16:44","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=82878"},"modified":"2021-09-06T09:16:44","modified_gmt":"2021-09-06T13:16:44","slug":"scientific-research-paper-remdesivir-and-acute-renal-failure","status":"publish","type":"post","link":"http:\/\/stateofthenation.co\/?p=82878","title":{"rendered":"SCIENTIFIC RESEARCH PAPER: Remdesivir and Acute Renal Failure"},"content":{"rendered":"<p><!--more--><\/p>\n<header id=\"heading\" class=\"heading\">\n<div id=\"full-view-heading\" class=\"full-view\">\n<h1 class=\"heading-title\">Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database<\/h1>\n<div class=\"inline-authors\">\n<div class=\"authors\">\n<div class=\"authors-list\"><span class=\"authors-list-item \"><a class=\"full-name\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/?term=G%C3%A9rard+AO&amp;cauthor_id=33340409\" data-ga-category=\"search\" data-ga-action=\"author_link\" data-ga-label=\"Alexandre O G\u00e9rard\">Alexandre O G\u00e9rard<\/a><sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span><a class=\"affiliation-link\" title=\"Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/#affiliation-1\">1<\/a><span class=\"author-sup-separator\">\u00a0<\/span><a class=\"affiliation-link\" title=\"Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/#affiliation-2\">2<\/a><\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \"><a class=\"full-name\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/?term=Laurain+A&amp;cauthor_id=33340409\" data-ga-category=\"search\" data-ga-action=\"author_link\" data-ga-label=\"Audrey Laurain\">Audrey Laurain<\/a><sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span><a class=\"affiliation-link\" title=\"Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/#affiliation-1\">1<\/a><\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \"><a class=\"full-name\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/?term=Fresse+A&amp;cauthor_id=33340409\" data-ga-category=\"search\" data-ga-action=\"author_link\" data-ga-label=\"Audrey Fresse\">Audrey Fresse<\/a><sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span><a class=\"affiliation-link\" title=\"Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/#affiliation-2\">2<\/a><\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \"><a class=\"full-name\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/?term=Parassol+N&amp;cauthor_id=33340409\" data-ga-category=\"search\" data-ga-action=\"author_link\" data-ga-label=\"Nad\u00e8ge Parassol\">Nad\u00e8ge Parassol<\/a><sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span><a class=\"affiliation-link\" title=\"Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/#affiliation-2\">2<\/a><\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \"><a class=\"full-name\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/?term=Muzzone+M&amp;cauthor_id=33340409\" data-ga-category=\"search\" data-ga-action=\"author_link\" data-ga-label=\"Marine Muzzone\">Marine Muzzone<\/a><sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span><a class=\"affiliation-link\" title=\"Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/#affiliation-2\">2<\/a><\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \"><a class=\"full-name\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/?term=Rocher+F&amp;cauthor_id=33340409\" data-ga-category=\"search\" data-ga-action=\"author_link\" data-ga-label=\"Fanny Rocher\">Fanny Rocher<\/a><sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span><a class=\"affiliation-link\" title=\"Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/#affiliation-2\">2<\/a><\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \"><a class=\"full-name\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/?term=Esnault+VLM&amp;cauthor_id=33340409\" data-ga-category=\"search\" data-ga-action=\"author_link\" data-ga-label=\"Vincent L M Esnault\">Vincent L M Esnault<\/a><sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span><a class=\"affiliation-link\" title=\"Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/#affiliation-1\">1<\/a><\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \"><a class=\"full-name\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/?term=Drici+MD&amp;cauthor_id=33340409\" data-ga-category=\"search\" data-ga-action=\"author_link\" data-ga-label=\"Milou-Daniel Drici\">Milou-Daniel Drici<\/a><sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span><a class=\"affiliation-link\" title=\"Department of Pharmacology and Pharmacovigilance, Centre Hospitalier Universitaire de Nice, Nice Cedex, France.\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/#affiliation-2\">2<\/a><\/sup><\/span><\/div>\n<\/div>\n<\/div>\n<div class=\"short-article-details\">Affiliations\u00a0<button id=\"toggle-authors\" class=\"more-details\" data-alt-text=\"Collapse\" aria-controls=\"expanded-authors\" aria-expanded=\"false\" data-pinger-ignore=\"\" data-fetch-url=\"\/33340409\/long-authors\/\" data-id-prefix=\"\"><span class=\"title\">expand<\/span><\/button><\/div>\n<ul id=\"full-view-identifiers\" class=\"identifiers\">\n<li><span class=\"identifier pubmed\"><span class=\"id-label\">PMID:\u00a0<\/span><strong class=\"current-id\" title=\"PubMed ID\">33340409<\/strong><\/span><\/li>\n<li><span class=\"identifier doi\"><span class=\"id-label\">DOI:\u00a0<\/span><a class=\"id-link\" href=\"https:\/\/doi.org\/10.1002\/cpt.2145\" target=\"_blank\" rel=\"noopener\" data-ga-category=\"full_text\" data-ga-action=\"DOI\">10.1002\/cpt.2145<\/a><\/span><\/li>\n<\/ul>\n<\/div>\n<\/header>\n<div id=\"abstract\" class=\"abstract\">\n<h2 class=\"title\">Abstract<\/h2>\n<div id=\"enc-abstract\" class=\"abstract-content selected\">\n<p>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 &#8220;acute renal failure&#8221; and &#8220;remdesivir&#8221; 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 &lt; 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.<\/p>\n<\/div>\n<\/div>\n<p id=\"copyright\" class=\"copyright\">\u00a9 2020 The Authors. Clinical Pharmacology &amp; Therapeutics \u00a9 2020 American Society for Clinical Pharmacology and Therapeutics.<\/p>\n<div id=\"similar\" class=\"similar-articles\">\n<h2 class=\"title\">Similar articles<\/h2>\n<ul id=\"similar-articles-list\" class=\"articles-list\">\n<li class=\"full-docsum\">\n<div class=\"docsum-content\"><a class=\"docsum-title\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/34374967\/\" data-ga-category=\"similar_article\" data-ga-action=\"34374967\" data-ga-label=\"\">Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020.<\/a><\/p>\n<div class=\"docsum-citation full-citation\"><span class=\"docsum-authors full-authors\">Rocca E, Gauffin O, Savage R, Vidlin SH, Grundmark B.<\/span><span class=\"docsum-journal-citation full-journal-citation\">Drug Saf. 2021 Sep;44(9):987-998. doi: 10.1007\/s40264-021-01091-x. 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Epub 2021 Feb 26.<\/span><span class=\"citation-part\">PMID:\u00a0<span class=\"docsum-pmid\">33647327<\/span><\/span>\u00a0<span class=\"free-resources spaced-citation-item citation-part\">Free PMC article.<\/span>\u00a0<span class=\"no-abstract spaced-citation-item citation-part\">No abstract available.<\/span><\/div>\n<\/div>\n<\/li>\n<\/ul>\n<\/div>\n<div id=\"references\" class=\"references\">\n<h3 class=\"title\">References<\/h3>\n<div id=\"top-references-list\" class=\"references-lists-container\">\n<div class=\"refs-list\">\n<ol id=\"top-references-list-1\" class=\"references-list\">\n<li>\n<ol class=\"references-and-notes-list\">\n<li class=\"skip-numbering\" value=\"1\">Jorgensen, S.C.J., Kebriaei, R. &amp; Dresser, L.D. Remdesivir: review of pharmacology, pre-clinical data, and emerging clinical experience for COVID-19. Pharmacother. J. Hum. Pharmacol. 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European Medicines Agency &lt;<a class=\"external-link-urlize\" href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-covid-19-treatment-recommended-eu-authorisation\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.ema.europa.eu\/en\/news\/first-covid-19-treatment-recommended-e&#8230;<\/a>&gt; (2020).<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<p>___<br \/>\n<a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/\">https:\/\/pubmed.ncbi.nlm.nih.gov\/33340409\/<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-82878","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/82878","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=82878"}],"version-history":[{"count":0,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/82878\/revisions"}],"wp:attachment":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=82878"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=82878"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=82878"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}