دورية أكاديمية
Clinical Equivalence between Generic Versus Branded Antibiotics: Systematic Review and Meta-Analysis.
| العنوان: | Clinical Equivalence between Generic Versus Branded Antibiotics: Systematic Review and Meta-Analysis. |
|---|---|
| المؤلفون: | Cotia A; MBA Program in Prevention of Healthcare Acquired Infections, Infectious Diseases Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo 05403-000, Brazil., Oliveira Junior HA; Health Technology Assessment Unit, Hospital Alemão Oswaldo Cruz, São Paulo 01323-903, Brazil., Matuoka JY; Health Technology Assessment Unit, Hospital Alemão Oswaldo Cruz, São Paulo 01323-903, Brazil., Boszczowski Í; Infection Control Department, Hospital Alemão Oswaldo Cruz, São Paulo 01323-020, Brazil.; Infection Control Department, Central Institute, Clinics Hospital, Medicine Faculty, Universidade de São Paulo, São Paulo 05403-010, Brazil. |
| المصدر: | Antibiotics (Basel, Switzerland) [Antibiotics (Basel)] 2023 May 21; Vol. 12 (5). Date of Electronic Publication: 2023 May 21. |
| نوع المنشور: | Journal Article; Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: MDPI AG Country of Publication: Switzerland NLM ID: 101637404 Publication Model: Electronic Cited Medium: Print ISSN: 2079-6382 (Print) Linking ISSN: 20796382 NLM ISO Abbreviation: Antibiotics (Basel) Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Original Publication: Basel, Switzerland : MDPI AG, 2012- |
| مستخلص: | Regulatory authorities authorize the clinical use of generic drugs (GD) based on bioequivalence studies, which consist of the evaluation of pharmacokinetics after a single dose in vitro or in healthy individuals. There are few data on clinical equivalence between generic and branded antibiotics. Our aim was to synthesize and analyze the available evidence on the clinical efficacy and safety of generic antibiotics compared to their original formulations. A systematic review was performed on Medline ( PubMed ) and Embase and validated through Epistemonikos and Google Scholar . The last search was conducted on 30 June 2022. Meta-analyses of clinical cure and mortality outcomes were performed. One randomized clinical trial (RCT) and 10 non-randomized intervention studies were included. No differences in clinical cure were observed between groups in the meta-analysis (OR = 0.89, 95% CI [0.61-1.28]; I 2 = 70%, p = 0.005). No difference was observed between groups when considering the use of carbapenems for overall mortality (OR = 0.99, 95% CI [0.63-1.55]; I 2 = 78%) or death associated with infections (OR = 0.79, 95% CI [0.48-1.29], I 2 = 67%). Most of the studies were observational, and the duration of follow-up, the characteristics of the participants, and the sites of infections were heterogeneous. Due to the uncertainty of the evidence, it is not possible to contraindicate the use of generics, which is an important strategy to expand access. |
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| فهرسة مساهمة: | Keywords: anti-bacterial agents; clinical equivalence; efficacy; generic antibiotics; systematic review |
| تواريخ الأحداث: | Date Created: 20230527 Latest Revision: 20230530 |
| رمز التحديث: | 20230530 |
| مُعرف محوري في PubMed: | PMC10215091 |
| DOI: | 10.3390/antibiotics12050935 |
| PMID: | 37237838 |
| قاعدة البيانات: | MEDLINE |
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