| アブストラクト | Objectives: Remdesivir has shown promise in the management of patients with COVID-19 although recent studies have shown concerns with its effectiveness in practice. Despite this there is a need to document potential adverse drug events (ADEs) to guide future decisions as limited ADE data available before the COVID-19 pandemic. Methods: Interrogation of WHO VigiBase(R) from 2015 to 2020 coupled with published studies of ADEs in COVID-19 patients. The main outcome measures are the extent of ADEs broken down by factors including age, seriousness, region and organ. Results: A total 1086 ADEs were reported from the 439 individual case reports up to July 19, 2020, in the VigiBase(R), reduced to 1004 once duplicates were excluded. Almost all ADEs concerned COVID-19 patients (92.5%), with an appreciable number from the Americas (67.7%). The majority of ADEs were from males > 45 years and were serious (82.5%). An increase in hepatic enzymes (32.1%), renal injury (14.4%), rise in creatinine levels (11.2%), and respiratory failure (6.4%) were the most frequently reported ADEs. Conclusions: Deterioration of liver and kidney function are frequently observed ADEs with remdesivir; consequently, patients should be monitored for these ADEs. The findings are in line with ADEs included in regulatory authority documents. |
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| 投稿者 | Charan, Jaykaran; Kaur, Rimple Jeet; Bhardwaj, Pankaj; Haque, Mainul; Sharma, Praveen; Misra, Sanjeev; Godman, Brian |
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| 組織名 | Department of Pharmacology, All India Institute of Medical Sciences , Jodhpur,;India.;Department of Pharmacology, S.N. Medical College , Jodhpur, India.;Department of Community and Family Medicine, All India Institute of Medical;Sciences , Jodhpur, India.;Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti;Pertahanan Nasional Malaysia (National Defence University of Malaysia) , Kuala;Lumpur, Malaysia.;Department of Biochemistry, All India Institute of Medical Sciences , Jodhpur,;Department of Surgical Oncology, All India Institute of Medical Sciences ,;Jodhpur, India.;Strathclyde Institute of Pharmacy and Biomedical Sciences, University of;Strathclyde , Glasgow, UK.;School of Pharmacy, Sefako Makgatho Health Sciences University , Pretoria, South;Africa.;School of Pharmaceutical Sciences, Universiti Sains Malaysia , Penang, Malaysia.;Division of Clinical Pharmacology, Karolinska Institute, Karolinska University;Hospital Huddinge , Stockholm, Sweden. |
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