Abstract Objective: Several studies showed that amoxicillin plus clavulanic acid (co-amoxiclav) is one of the most common agents associated to serious Drug Induced Liver Injury (DILI). We estimated the risk of acute serious DILI associated with amoxicillin alone compared with co-amoxiclav, through a multicenter case-control study carried out in nine Italian hospitals from October 2010 to January 2014. Methods: Cases were adults, with a diagnosis of acute liver injury. Controls presented acute clinical disorders, not related to chronic conditions and not involving the liver. Adjusted Odds Ratio (ORs) with 95% CI were calculated initially with a bivariate and then multivariate analysis. Results: We analysed 179 cases matched to 1770 controls. Seven cases were exposed to amoxicillin (adjusted OR 1.69, 95% CI 0.72-3.98) and 22 cases to co-amoxiclav (adjusted OR 3.00, 95% CI 1.76-5.40). Conclusions: Co-amoxiclav almost doubled the risk of serious acute liver injury compared to amoxicillin alone. The incidence of co-amoxiclav induced DILI is very low but the widespread use of this drug by the general population makes the risk clinically relevant. The often inappropriate prescription of antimicrobial agents, and in particular of co-amoxiclav, could expose a given patient to a life-threatening risk compared to a negligible clinical benefit.

Liver Injury due to Amoxicillin vs. Amoxicillin/Clavulanate: A Subgroup Analysis of a Drug-Induced Liver Injury Case-Control Study in Italy / Donati, Monia; Motola, Domenico; Leone, Roberto; Moretti, Ugo; Stoppa, Giovanna; Arzenton, Elena; Maria, Carmela Lenti; Bonaiuti, Roberto; Mugelli, Alessandro; Vannacci, Alfredo; Rafaniello, Concetta; Sportiello, Liberata; Capuano, Annalisa; Bortolami, Oscar; Vaccheri, Alberto. - In: JOURNAL OF HEPATOLOGY AND GASTROINTESTINAL DISORDERS. - ISSN 2475-3181. - ELETTRONICO. - 03:(2017), pp. 1-5. [10.4172/2475-3181.1000143]

Liver Injury due to Amoxicillin vs. Amoxicillin/Clavulanate: A Subgroup Analysis of a Drug-Induced Liver Injury Case-Control Study in Italy

Carmela Lenti, Maria;Bonaiuti, Roberto;Mugelli, Alessandro;Vannacci, Alfredo;
2017

Abstract

Abstract Objective: Several studies showed that amoxicillin plus clavulanic acid (co-amoxiclav) is one of the most common agents associated to serious Drug Induced Liver Injury (DILI). We estimated the risk of acute serious DILI associated with amoxicillin alone compared with co-amoxiclav, through a multicenter case-control study carried out in nine Italian hospitals from October 2010 to January 2014. Methods: Cases were adults, with a diagnosis of acute liver injury. Controls presented acute clinical disorders, not related to chronic conditions and not involving the liver. Adjusted Odds Ratio (ORs) with 95% CI were calculated initially with a bivariate and then multivariate analysis. Results: We analysed 179 cases matched to 1770 controls. Seven cases were exposed to amoxicillin (adjusted OR 1.69, 95% CI 0.72-3.98) and 22 cases to co-amoxiclav (adjusted OR 3.00, 95% CI 1.76-5.40). Conclusions: Co-amoxiclav almost doubled the risk of serious acute liver injury compared to amoxicillin alone. The incidence of co-amoxiclav induced DILI is very low but the widespread use of this drug by the general population makes the risk clinically relevant. The often inappropriate prescription of antimicrobial agents, and in particular of co-amoxiclav, could expose a given patient to a life-threatening risk compared to a negligible clinical benefit.
2017
03
1
5
Donati, Monia; Motola, Domenico; Leone, Roberto; Moretti, Ugo; Stoppa, Giovanna; Arzenton, Elena; Maria, Carmela Lenti; Bonaiuti, Roberto; Mugelli, Alessandro; Vannacci, Alfredo; Rafaniello, Concetta; Sportiello, Liberata; Capuano, Annalisa; Bortolami, Oscar; Vaccheri, Alberto
File in questo prodotto:
File Dimensione Formato  
liver-injury-due-to-amoxicillin-vs-amoxicillinclavulanate-a-subgroupanalysis-of-a-druginduced-liver-injury-casecontrol-study-in-it-2475-3181-1000143.pdf

accesso aperto

Tipologia: Pdf editoriale (Version of record)
Licenza: Open Access
Dimensione 387.47 kB
Formato Adobe PDF
387.47 kB Adobe PDF

I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1104847
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? ND
social impact