Clinical Pharmacology of Antimicrobials: Focus on the Safety of Vancomycin and Linezolid
Scientific relevance. Vancomycin and linezolid are the antibacterial agents of choice for severe infections caused by multidrug-resistant pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). However, few studies have been conducted in Russia to analyse the safety of these medicin...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2023-12-01
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| Series: | Безопасность и риск фармакотерапии |
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| Online Access: | https://www.risksafety.ru/jour/article/view/337 |
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| author | M. V. Zhuravleva E. V. Kuznetsova N. G. Berdnikova A. B. Prokofiev T. R. Kameneva E. Yu. Demchenkova |
| author_facet | M. V. Zhuravleva E. V. Kuznetsova N. G. Berdnikova A. B. Prokofiev T. R. Kameneva E. Yu. Demchenkova |
| author_sort | M. V. Zhuravleva |
| collection | DOAJ |
| description | Scientific relevance. Vancomycin and linezolid are the antibacterial agents of choice for severe infections caused by multidrug-resistant pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). However, few studies have been conducted in Russia to analyse the safety of these medicinal products.Aim. The study aimed to compare the safety of vancomycin and linezolid using the Moscow segment of the Russian Federal Service for Surveillance in Healthcare’s database for adverse drug reaction (ADR) reports.Materials and methods. The study used information from the spontaneous reporting database for 2018–2022, which contained 147 ADR reports for vancomycin (122 reports) and linezolid (25 reports). The authors analysed the ADR distribution and assessed the statistical significance of the identified differences by sex, weight, and age of patients, conditions of medical care, route of administration, single dose, daily dose, therapy duration, ICD-10 codes, ADR severity, and ADR outcome.Results. The distribution of adverse reactions to vancomycin and linezolid by patient age was relatively uniform. Outpatient linezolid was associated with a significantly higher rate of ADRs (3 of 5 reports) than outpatient vancomycin (21 of 129 reports; p=0.0408). For ADR severity, 5 of 20 ADRs reported with linezolid required hospitalisation or prolongation of hospitalisation—considerably more than with vancomycin (16 of 94 reports; p=0.528). The average single dose of vancomycin (794 mg) was higher than that of linezolid (467 mg; p=0.007); the same was noted for average daily doses (1273 mg vs 998 mg; p=0.3664). The mean duration of treatment with linezolid before ADR onset was 5.26 days, which was significantly longer than the mean duration of treatment with vancomycin (2.44 days; p=0.0053). Oral linezolid was associated with a significantly higher ADR rate (4 of 19 cases) than oral vancomycin (5 of 96 cases; p=0.0027).Conclusions. The ADRs observed with vancomycin and linezolid were predictable and class-specific. According to the results of the ADR report analysis, adverse reactions to vancomycin and linezolid were associated with different factors. Similar results of the literature analysis confirmed this conclusion. However, according to the results of the linear regression analysis, none of the factors considered in this study had a statistically significant influence on the probability of developing an adverse reaction to vancomycin or linezolid. |
| first_indexed | 2024-03-08T22:26:53Z |
| format | Article |
| id | doaj.art-f00c8258fe57441cba0f761819381bf3 |
| institution | Directory Open Access Journal |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| last_indexed | 2025-03-14T10:50:31Z |
| publishDate | 2023-12-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj.art-f00c8258fe57441cba0f761819381bf32025-03-02T10:50:06ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642023-12-0111443044110.30895/2312-7821-2023-337317Clinical Pharmacology of Antimicrobials: Focus on the Safety of Vancomycin and LinezolidM. V. Zhuravleva0E. V. Kuznetsova1N. G. Berdnikova2A. B. Prokofiev3T. R. Kameneva4E. Yu. Demchenkova5Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation; I.V. Davydovsky City Clinical HospitalResearch Institute for Healthcare Organisation and Medical Management of the Moscow Healthcare DepartmentI.V. Davydovsky City Clinical HospitalScientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation; I.V. Davydovsky City Clinical HospitalResearch Institute for Healthcare Organisation and Medical Management of the Moscow Healthcare Department; M.P. Konchalovsky City Clinical HospitalScientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation; I.V. Davydovsky City Clinical HospitalScientific relevance. Vancomycin and linezolid are the antibacterial agents of choice for severe infections caused by multidrug-resistant pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). However, few studies have been conducted in Russia to analyse the safety of these medicinal products.Aim. The study aimed to compare the safety of vancomycin and linezolid using the Moscow segment of the Russian Federal Service for Surveillance in Healthcare’s database for adverse drug reaction (ADR) reports.Materials and methods. The study used information from the spontaneous reporting database for 2018–2022, which contained 147 ADR reports for vancomycin (122 reports) and linezolid (25 reports). The authors analysed the ADR distribution and assessed the statistical significance of the identified differences by sex, weight, and age of patients, conditions of medical care, route of administration, single dose, daily dose, therapy duration, ICD-10 codes, ADR severity, and ADR outcome.Results. The distribution of adverse reactions to vancomycin and linezolid by patient age was relatively uniform. Outpatient linezolid was associated with a significantly higher rate of ADRs (3 of 5 reports) than outpatient vancomycin (21 of 129 reports; p=0.0408). For ADR severity, 5 of 20 ADRs reported with linezolid required hospitalisation or prolongation of hospitalisation—considerably more than with vancomycin (16 of 94 reports; p=0.528). The average single dose of vancomycin (794 mg) was higher than that of linezolid (467 mg; p=0.007); the same was noted for average daily doses (1273 mg vs 998 mg; p=0.3664). The mean duration of treatment with linezolid before ADR onset was 5.26 days, which was significantly longer than the mean duration of treatment with vancomycin (2.44 days; p=0.0053). Oral linezolid was associated with a significantly higher ADR rate (4 of 19 cases) than oral vancomycin (5 of 96 cases; p=0.0027).Conclusions. The ADRs observed with vancomycin and linezolid were predictable and class-specific. According to the results of the ADR report analysis, adverse reactions to vancomycin and linezolid were associated with different factors. Similar results of the literature analysis confirmed this conclusion. However, according to the results of the linear regression analysis, none of the factors considered in this study had a statistically significant influence on the probability of developing an adverse reaction to vancomycin or linezolid.https://www.risksafety.ru/jour/article/view/337vancomycinlinezolidadverse drug reactionspharmacovigilanceantibioticsnosocomial infectionsmultidrug resistanceuse of medicinal productsspontaneous reports |
| spellingShingle | M. V. Zhuravleva E. V. Kuznetsova N. G. Berdnikova A. B. Prokofiev T. R. Kameneva E. Yu. Demchenkova Clinical Pharmacology of Antimicrobials: Focus on the Safety of Vancomycin and Linezolid Безопасность и риск фармакотерапии vancomycin linezolid adverse drug reactions pharmacovigilance antibiotics nosocomial infections multidrug resistance use of medicinal products spontaneous reports |
| title | Clinical Pharmacology of Antimicrobials: Focus on the Safety of Vancomycin and Linezolid |
| title_full | Clinical Pharmacology of Antimicrobials: Focus on the Safety of Vancomycin and Linezolid |
| title_fullStr | Clinical Pharmacology of Antimicrobials: Focus on the Safety of Vancomycin and Linezolid |
| title_full_unstemmed | Clinical Pharmacology of Antimicrobials: Focus on the Safety of Vancomycin and Linezolid |
| title_short | Clinical Pharmacology of Antimicrobials: Focus on the Safety of Vancomycin and Linezolid |
| title_sort | clinical pharmacology of antimicrobials focus on the safety of vancomycin and linezolid |
| topic | vancomycin linezolid adverse drug reactions pharmacovigilance antibiotics nosocomial infections multidrug resistance use of medicinal products spontaneous reports |
| url | https://www.risksafety.ru/jour/article/view/337 |
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