6b044955806f9bf690a5c53532101cca 264085.pdf 6d43705105a05738636bf7c451a1d80cecf0aea3 264085.pdf d12c96649151f6656245c748b5e5ddeb7206098e5296dc29e45309ebbec6462d 264085.pdf Title: Safety of Drugs Used during the First Wave of COVID-19: A Hospital-Registry-Based Study Subject: The emergency of the coronavirus disease 2019 (COVID-19) pandemic led to the off-label use of drugs without data on their toxicity profiles in patients with COVID-19, or on their concomitant use. Patients included in the COVID-19 Patient Registry of a tertiary hospital during the first wave were analyzed to evaluate the adverse drug reactions (ADRs) with the selected treatments. Twenty-one percent of patients (197 out of 933) had at least one ADR, with a total of 240 ADRs. Patients with ADRs were more commonly treated with multiple drugs for COVID-19 infection than patients without ADRs (p < 0.001). They were younger (median 62 years vs. 70.1 years; p < 0.001) and took less medication regularly (69.5% vs. 75.7%; p = 0.031). The most frequent ADRs were gastrointestinal (67.1%), hepatobiliary (10.8%), and cardiac disorders (3.3%). Drugs more frequently involved included lopinavir/ritonavir (82.2%), hydroxychloroquine (72.1%), and azithromycin (66.5%). Although most ADRs recovered without sequelae, fatal cases were described, even though the role of the disease could not be completely ruled out. In similar situations, efforts should be made to use the drugs in the context of clinical trials, and to limit off-label use to those drugs with a better benefit/risk profile in specific situations and for patients at high risk of poor disease prognosis. Keywords: adverse drug reactions; off-label use; registries; COVID-19; lopinavir/ritonavir; hydroxychloroquine Author: Cristina Aguilera, Immaculada Danés, Elena Guillén, Alba Vimes, Montserrat Bosch, Gloria Cereza, Adrián Sánchez-Montalvá, Isabel Campos-Varela, Marta Miarons, Jaume Mestre-Torres and Antònia Agustí Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Fri Jul 15 06:24:26 2022 CEST ModDate: Fri Jul 15 06:29:37 2022 CEST Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 11 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 280806 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- VACWFK+URWPalladioL-Bold Type 1 Custom yes yes no 10 0 WYUSCM+URWPalladioL-Roma Type 1 Custom yes yes no 15 0 ZPDMWS+URWPalladioL-Ital Type 1 Custom yes yes no 19 0 GFKJOY+VnURWPalladioL Type 1 Custom yes yes no 23 0 MPDLZD+VnURWPalladioL-Bold Type 1 Custom yes yes no 28 0 BXZUUH+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 46 0 PDTLUH+CMSY10 Type 1 Builtin yes yes no 71 0 QLBIEB+URWPalladioL-BoldItal Type 1 Custom yes yes no 78 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2022-10-19 02:33:57 CEST RepresentationInformation: 264085.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2022-10-18 11:30:37 CEST Size: 280806 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 209 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@4923ab24 Item: Title: Materials and Methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@44c8afef Item: Title: Results Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7b69c6ba Item: Title: Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@46daef40 Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@12f41634 Info: Title: Safety of Drugs Used during the First Wave of COVID-19: A Hospital-Registry-Based Study Author: Cristina Aguilera, Immaculada Danés, Elena Guillén, Alba Vimes, Montserrat Bosch, Gloria Cereza, Adrián Sánchez-Montalvá, Isabel Campos-Varela, Marta Miarons, Jaume Mestre-Torres and Antònia Agustí Subject: The emergency of the coronavirus disease 2019 (COVID-19) pandemic led to the off-label use of drugs without data on their toxicity profiles in patients with COVID-19, or on their concomitant use. Patients included in the COVID-19 Patient Registry of a tertiary hospital during the first wave were analyzed to evaluate the adverse drug reactions (ADRs) with the selected treatments. Twenty-one percent of patients (197 out of 933) had at least one ADR, with a total of 240 ADRs. Patients with ADRs were more commonly treated with multiple drugs for COVID-19 infection than patients without ADRs (p < 0.001). They were younger (median 62 years vs. 70.1 years; p < 0.001) and took less medication regularly (69.5% vs. 75.7%; p = 0.031). The most frequent ADRs were gastrointestinal (67.1%), hepatobiliary (10.8%), and cardiac disorders (3.3%). Drugs more frequently involved included lopinavir/ritonavir (82.2%), hydroxychloroquine (72.1%), and azithromycin (66.5%). Although most ADRs recovered without sequelae, fatal cases were described, even though the role of the disease could not be completely ruled out. In similar situations, efforts should be made to use the drugs in the context of clinical trials, and to limit off-label use to those drugs with a better benefit/risk profile in specific situations and for patients at high risk of poor disease prognosis. 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