Academic Journal
Model for predicting risk of developing drug-induced liver injury during remdesivir therapy: observational prospective open case-control study ; Модель прогнозирования риска развития лекарственного поражения печени на фоне терапии ремдесивиром: обсервационное проспективное открытое контролируемое исследование
العنوان: | Model for predicting risk of developing drug-induced liver injury during remdesivir therapy: observational prospective open case-control study ; Модель прогнозирования риска развития лекарственного поражения печени на фоне терапии ремдесивиром: обсервационное проспективное открытое контролируемое исследование |
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المؤلفون: | Yu. V. Shevchuk, A. V. Kryukov, I. I. Temirbulatov, I. V. Sychev, K. B. Mirzaev, N. P. Denisenko, Sh. P. Abdullaev, S. N. Tuchkova, V. I. Vechorko, O. V. Averkov, D. A. Sychev, Ю. В. Шевчук, А. В. Крюков, И. И. Темирбулатов, И. В. Сычев, К. Б. Мирзаев, Н. П. Денисенко, Ш. П. Абдуллаев, С. Н. Тучкова, В. И. Вечорко, О. В. Аверков, Д. А. Сычев |
المساهمون: | The present study was carried out with the financial support of the Ministry of Health of the Russian Federation, the subject of the state task was “Development of a medical decision support system for predicting adverse drug reactions in COVID-19 patients based on pharmacogenetic testing” (INIS RTD No. 122021800321-2)., Данная работа выполнена при финансовой поддержке Министерства здравоохранения Российской Федерации тематика государственного задания «Разработка системы поддержки принятия врачебных решений для прогнозирования нежелательных лекарственных реакций у пациентов с COVID-19 на основе фармакогенетического тестирования» (ЕГИСУ НИОКТР №122021800321-2). |
المصدر: | Pharmacy & Pharmacology; Том 11, № 3 (2023); 228-239 ; Фармация и фармакология; Том 11, № 3 (2023); 228-239 ; 2413-2241 ; 2307-9266 ; 10.19163/2307-9266-2023-11-3 |
بيانات النشر: | Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer |
سنة النشر: | 2023 |
المجموعة: | Pharmacy & Pharmacology (E-Journal) / Фармация и фармакология |
مصطلحات موضوعية: | клиническое исследование, remdesivir, hepatotoxicity, adverse reactions, predictors of adverse reactions, pharmacogenetic study, clinical trial, ремдесивир, гепатотоксичность, нежелательные реакции, предикторы нежелательных реакций, фармакогенетическое исследование |
الوصف: | Remdesivir is a drug widely used for the etiotropic treatment of COVID-19. According to a number of studies, the incidence of adverse reactions during remdesivir therapy reaches 66%, with the most common is an increase in liver function tests.The aim of the work was to study the influence of clinical, demographic and pharmacogenetic factors on the development of drug-induced liver damage during remdesivir therapy in COVID-19 patients.Materials and methods. The study comprised 100 hospitalized patients treated with remdesivir. The patients were divided into two groups: group 1 (n=32) – remdesivir therapy, developed an increase in the level of liver transaminases; group 2 (control, n=68) – did not develop this adverse reaction. The patients in both groups underwent a pharmacogenetic study, and a retrospective analysis of medical records was performed. Based on the data obtained, the association of clinical, laboratory, pharmacological and pharmacogenetic parameters with the development of drug-induced liver damage during remdesivir therapy was studied.Results. In the group of patients with the development of drug-induced liver damage, people with a high body mass index were significantly more likely than in the control group (30.7±4.2 kg/m2 in group 1 vs. 27.3±5.5 kg/m2 in group 2, p=0.003), with a history of diabetes mellitus (odds ratio (OR)=2.647, 95% confidence interval (CI)=1.092–6.414, χ2=4.785, p=0.029), with higher levels of ferritin in the blood (724.03±432.27 and 553.19±358.48 mg/mol, respectively, p=0.040), receiving therapy with angiotensin-converting enzyme inhibitors (OR=5.440, 95% CI=2.160–13.699, χ2=14.027, p=0.000), statins (OR=3.148, 95% CI=1.307–7.581, χ2=6.795, p=0.009), and also being heterozygous for the polymorphic marker rs776746 of the CYP3A5 gene (OR=3.961, 95% CI=1.343–11.686, χ2=6.772, p=0.009).Conclusion. A high body mass index, a history of diabetes mellitus, high levels of ferritin in the blood, concomitant therapy with angiotensin-converting enzyme inhibitors and statins, as well as ... |
نوع الوثيقة: | article in journal/newspaper |
وصف الملف: | application/pdf |
اللغة: | Russian English |
Relation: | https://www.pharmpharm.ru/jour/article/view/1355/983; https://www.pharmpharm.ru/jour/article/view/1355/984; Alsuhaibani D.S., Edrees H.H., Alshammari T.M. The use and safety risk of repurposed drugs for COVID-19 patients: lessons learned utilizing the Food and Drug Administration’s Adverse Event Reporting System // Saudi Pharm J. – 2023. – Vol. 31, No. 7. – P. 1360–1366. DOI:10.1016/j.jsps.2023.05.023; Pantazis N., Pechlivanidou E., Antoniadou A., Akinosoglou K., Kalomenidis I., Poulakou G., Milionis H., Panagopoulos P., Marangos M., Katsarolis I., Kazakou P., Dimakopoulou V., Chaliasou AL., Rapti V., Christaki E., Liontos A., Petrakis V., Schinas G., Biros D., Rimpa M.C., Touloumi G. Remdesivir: Effectiveness and Safety in Hospitalized Patients with COVID-19 (ReEs-COVID-19)-Analysis of Data from Daily Practice // Microorganisms. – 2023. – Vol. 11, No. 8. – Art. ID: 1998. DOI:10.3390/microorganisms11081998; Deb S., Reeves A.A., Hopefl R., Bejusca R. ADME and Pharmacokinetic Properties of Remdesivir: Its Drug Interaction Potential // Pharmaceuticals (Basel). – 2021. – Vol. 14, No. 7. – Art. ID: 655. DOI:10.3390/ph14070655; Zhang Q., Melchert P.W., Markowitz J.S. In vitro evaluation of the impact of Covid-19 therapeutic agents on the hydrolysis of the antiviral prodrug remdesivir // Chem Biol Interact. – 2022. – Vol. 365. – Art. ID: 110097. DOI:10.1016/j.cbi.2022.110097; Pratt V.M., Cavallari L.H., Fulmer M.L., Gaedigk A., Hachad H., Ji Y., Kalman L.V., Ly R.C., Moyer A.M., Scott S.A., van Schaik R.H.N., Whirl-Carrillo M., Weck K.E. CYP3A4 and CYP3A5 Genotyping Recommendations: A Joint Consensus Recommendation of the Association for Molecular Pathology, Clinical Pharmacogenetics Implementation Consortium, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, European Society for Pharmacogenomics and Personalized Therapy, and Pharmacogenomics Knowledgebase // J Mol Diagn. – 2023. – Vol. 25, No. 9. – P. 619–629. DOI:10.1016/j.jmoldx.2023.06.008; Flockhart D.A., Thacker D., McDonald C., Desta Z. The Flockhart Cytochrome P450 Drug-Drug Interaction Table. Division of Clinical Pharmacology, Indiana University School of Medicine (Updated 2021). – [Электронный ресурс]. – Режим доступа: https://drug-interactions.medicine.iu.edu/.; Whirl-Carrillo M., Huddart R., Gong L., Sangkuhl K., Thorn C.F., Whaley R., Klein T.E. An Evidence-Based Framework for Evaluating Pharmacogenomics Knowledge for Personalized Medicine // Clin Pharmacol Ther. – 2021. – Vol. 110, No. 3. – P. 563–572. DOI:10.1002/cpt.2350; Wang Y., Zhang D., Du G., Du R., Zhao J., Jin Y., Fu S., Gao L., Cheng Z., Lu Q., Hu Y., Luo G., Wang K., Lu Y., Li H., Wang S., Ruan S., Yang C., Mei C., Wang Y., Ding D., Wu F., Tang X., Ye X., Ye Y., Liu B., Yang J., Yin W., Wang A., Fan G., Zhou F., Liu Z., Gu X., Xu J., Shang L., Zhang Y., Cao L., Guo T., Wan Y., Qin H., Jiang Y., Jaki T., Hayden FG., Horby PW., Cao B., Wang C. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial // Lancet. – 2020. – Vol. 395, No. 10236. – P. 1569–1578. DOI:10.1016/S0140-6736, No. 20)31022-9; Touafchia A., Bagheri H., Carrié D., Durrieu G., Sommet A., Chouchana L., Montastruc F. Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19. – P. a new safety concerns // Clin Microbiol Infect. – 2021. – Vol. 27, No. 5. – P. 791.e5–8. DOI:10.1016/j.cmi.2021.02.013; Gérard A.O., Laurain A., Fresse A., Parassol N., Muzzone M., Rocher F., Esnault V.L.M,. Drici M.D. Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database // Clin Pharmacol Ther. – 2021. – Vol. 109, No. 4. – P. 1021–1024. DOI:10.1002/cpt.2145; Nazir N., Chopra D., Bhandari B., Sidhu J.K. Adverse Drug Reactions in Corona Virus Disease Patients Admitted to Intensive Care Unit: An Observational Study // Curr Drug Saf. – 2023. – Vol. 18, No. 2. – P. 202–206. DOI:10.2174/1574886317666220513095618; Merad M, Blish CA, Sallusto F, Iwasaki A. The immunology and immunopathology of COVID-19 // Science. – 2022. – Vol. 375, No. 6585. – P. 1122–1127. DOI:10.1126/science.abm8108; Stavropoulou E., Pircalabioru G.G., Bezirtzoglou E. The Role of Cytochromes P450 in Infection // Front Immunol. 2018. – Vol. 9. – Art. ID: 89. DOI:10.3389/fimmu.2018.00089; Morgan E.T. Impact of infectious and inflammatory disease on cytochrome P450-mediated drug metabolism and pharmacokinetics // Clin Pharmacol Ther. – 2009. – Vol. 85, No. 4. – P. 434–438. DOI:10.1038/clpt.2008.302; Habib H.M., Ibrahim S., Zaim A., Ibrahim W.H. The role of iron in the pathogenesis of COVID-19 and possible treatment with lactoferrin and other iron chelators // Biomed Pharmacother. – 2021. – Vol. 136. – Art. ID: 111228. DOI:10.1016/j.biopha.2021.111228; Stone J.H., Frigault M.J., Serling-Boyd N.J., Fernandes A.D., Harvey L., Foulkes A.S., Horick N.K., Healy B.C., Shah R., Bensaci A.M., Woolley A.E., Nikiforow S., Lin N., Sagar M., Schrager H., Huckins D.S., Axelrod M., Pincus M.D., Fleisher J., Sacks C.A., Dougan M., North C.M., Halvorsen Y.D., Thurber T.K., Dagher Z., Scherer A., Wallwork R.S., Kim A.Y., Schoenfeld S., Sen P., Neilan T.G., Perugino C.A., Unizony S.H., Collier D.S., Matza M.A., Yinh J.M., Bowman K.A., Meyerowitz E., Zafar A., Drobni Z.D., Bolster M.B., Kohler M., D’Silva K.M., Dau J., Lockwood M.M., Cubbison C., Weber B.N., Mansour M.K; BACC Bay Tocilizumab Trial Investigators. Efficacy of Tocilizumab in Patients Hospitalized with Covid-19 // N Engl J Med. – 2020. – Vol. 383, No. 24. – P. 2333–2344. DOI:10.1056/NEJMoa2028836.; Perrone F., Piccirillo M.C., Ascierto PA., Salvarani C., Parrella R., Marata A.M., Popoli P., Ferraris L., Marrocco-Trischitta M.M., Ripamonti D., Binda F., Bonfanti P., Squillace N., Castelli F., Muiesan M.L., Lichtner M., Calzetti C., Salerno N.D., Atripaldi L., Cascella M., Costantini M., Dolci G., Facciolongo N.C., Fraganza F., Massari M., Montesarchio V., Mussini C., Negri E.A., Botti G., Cardone C., Gargiulo P., Gravina A., Schettino C., Arenare L., Chiodini P., Gallo C.;TOCIVID-19 investigators, Italy. Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial // J Transl Med. – 2020. – Vol. 18, No. 1. – Art. ID: 405. DOI:10.1186/s12967-020-02573-9.; Lescure F.X., Honda H., Fowler R.A., Lazar J.S., Shi G., Wung P., Patel N., Hagino O.; Sarilumab COVID-19 Global Study Group. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial // Lancet Respir Med. – 2021. – Vol. 9, No. 5. – P. 522–532. DOI:10.1016/S2213-2600(21)00099-0; Hermine O., Mariette X., Porcher R., Resche-Rigon M., Tharaux P.L., Ravaud P.; CORIMUNO-19 Collaborative Group. Effect of interleukin-6 receptor antagonists in critically ill adult patients with COVID-19 pneumonia: two randomised controlled trials of the CORIMUNO-19 Collaborative Group // Eur Respir J. – 2022. – Vol. 60, No. 2. – Art. ID: 2102523. DOI:10.1183/13993003.02523-2021; Cavalli G., De Luca G., Campochiaro C., Della-Torre E., Ripa M., Canetti D., Oltolini C., Castiglioni B., Tassan Din C., Boffini N., Tomelleri A., Farina N., Ruggeri A., Rovere-Querini P., Di Lucca G., Martinenghi S., Scotti R., Tresoldi M., Ciceri F., Landoni G., Zangrillo A., Scarpellini P., Dagna L. Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study // Lancet Rheumatol. – 2020. – Vol. 2, No. 6. – P. e325-e331. DOI:10.1016/S2665-9913(20)30127-2; Kyriazopoulou E., Poulakou G., Milionis H., Metallidis S., Adamis G., Tsiakos K., Fragkou A., Rapti A., Damoulari C., Fantoni M., Kalomenidis I., Chrysos G., Angheben A., Kainis I., Alexiou Z., Castelli F., Serino FS., Tsilika M., Bakakos P., Nicastri E., Tzavara V., Kostis E., Dagna L., Koufargyris P., Dimakou K., Savvanis S., Tzatzagou G., Chini M., Cavalli G., Bassetti M., Katrini K., Kotsis V., Tsoukalas G., Selmi C., Bliziotis I., Samarkos M., Doumas M., Ktena S., Masgala A., Papanikolaou I., Kosmidou M., Myrodia DM., Argyraki A., Cardellino CS., Koliakou K., Katsigianni E.I., Rapti V., Giannitsioti E., Cingolani A., Micha S., Akinosoglou K., Liatsis-Douvitsas O., Symbardi S., Gatselis N., Mouktaroudi M., Ippolito G., Florou E., Kotsaki A., Netea M.G., Eugen-Olsen J., Kyprianou M., Panagopoulos P., Dalekos G.N., Giamarellos-Bourboulis E.J. Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial // Nat Med. – 2021. – Vol. 27, No. 10. – P. 1752–1760. DOI:10.1038/s41591-021-01499-z; Huet T., Beaussier H., Voisin O., Jouveshomme S., Dauriat G., Lazareth I., Sacco E., Naccache J.M., Bézie Y., Laplanche S., Le Berre A., Le Pavec J., Salmeron S., Emmerich J., Mourad J.J., Chatellier G., Hayem G. Anakinra for severe forms of COVID-19: a cohort study // Lancet Rheumatol. – 2020. – Vol. 2, No. 7. – P. e393–e400. DOI:10.1016/S2665-9913(20)30164-8; Lomakin N.V., Bakirov B.A., Protsenko D.N., Mazurov V.I., Musaev G.H., Moiseeva O.M., Pasechnik E.S., Popov V.V., Smolyarchuk E.A., Gordeev I.G., Gilyarov M.Y., Fomina D.S., Seleznev A.I., Linkova Y.N., Dokukina E.A., Eremeeva A.V., Pukhtinskaia P.S., Morozova M.A., Zinkina-Orikhan A.V., Lutckii A.A. The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study // Inflamm Res. – 2021. – Vol. 70, No. 10–12. – P. 1233–1246. DOI:10.1007/s00011-021-01507-5; Jorgensen S.C.J., Tse C.L.Y., Burry L., Dresser L.D. Baricitinib: A Review of Pharmacology, Safety, and Emerging Clinical Experience in COVID-19 // Pharmacotherapy. – 2020. – Vol. 40, No. 8. – P. 843–856. DOI:10.1002/phar.2438; Blair H.A. Remdesivir: A Review in COVID-19 // Drugs. – 2023. – Vol. 83, No. 13. – P. 1215–1237. DOI:10.1007/s40265-023-01926-0; https://www.pharmpharm.ru/jour/article/view/1355 |
DOI: | 10.19163/2307-9266-2023-11-3-228-239 |
الاتاحة: | https://www.pharmpharm.ru/jour/article/view/1355 https://doi.org/10.19163/2307-9266-2023-11-3-228-239 |
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رقم الانضمام: | edsbas.4A8289B0 |
قاعدة البيانات: | BASE |
DOI: | 10.19163/2307-9266-2023-11-3-228-239 |
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