Effects of Long-term Norfloxacin Therapy in Patients with Advanced Cirrhosis. - Université de Lille Accéder directement au contenu
Article Dans Une Revue Gastroenterology Année : 2018

Effects of Long-term Norfloxacin Therapy in Patients with Advanced Cirrhosis.

Laure Elkrief
  • Fonction : Auteur
Christophe Bureau
  • Fonction : Auteur
Jean-Marc Perarnau
  • Fonction : Auteur
Thierry Thevenot
  • Fonction : Auteur
Faouzi Saliba
  • Fonction : Auteur
Adrien Lannes
  • Fonction : Auteur
Rodolphe Anty
  • Fonction : Auteur
Sophie Hillaire
  • Fonction : Auteur
Blandine Pasquet
  • Fonction : Auteur
Violaine Ozenne
  • Fonction : Auteur
Marika Rudler
  • Fonction : Auteur
Isabelle Ollivier-Hourmand
  • Fonction : Auteur
Angele Robic Marie
  • Fonction : Auteur
Louis d'Alteroche
  • Fonction : Auteur
Vincent Di Martino
  • Fonction : Auteur
Marie-Pierre Ripault
  • Fonction : Auteur
Arnaud Pauwels
  • Fonction : Auteur
Jean-Didier Grange
  • Fonction : Auteur
Nicolas Carbonell
  • Fonction : Auteur
Audrey Payance
  • Fonction : Auteur
Pierre-Emmanuel Rautou
  • Fonction : Auteur
Didier Lebrec
  • Fonction : Auteur

Résumé

Background & Aims: There is debate over the effects of long-term oral fluoroquinolone therapy in patients with advanced cirrhosis. We performed a randomized controlled trial to evaluate the effects of long-term treatment with the fluoroquinolone norfloxacin on survival of patients with cirrhosis. Methods: We performed a double-blind trial of 291 patients with Child-Pugh class C cirrhosis who had not received recent fluoroquinolone therapy. The study was performed at 18 clinical sites in France from April 2010 through November 2014. Patients were randomly assigned to groups given 400 mg norfloxacin (n = 144) or placebo (n = 147) once daily for 6 months. Patients were evaluated monthly for the first 6 months and at 9 months and 12 months thereafter. The primary outcome was 6-month mortality, estimated by the Kaplan–Meier method, censoring spontaneous bacterial peritonitis, liver transplantation, or loss during follow-up. Results: The Kaplan–Meier estimate for 6-month mortality was 14.8% for patients receiving norfloxacin and 19.7% for patients receiving placebo (P = .21). In competing risk analysis that took liver transplantation into account, the cumulative incidence of death at 6 months was significantly lower in the norfloxacin group than in the placebo group (subdistribution hazard ratio, 0.59; 95% confidence interval, 0.35–0.99). The subdistribution hazard ratio for death at 6 months with norfloxacin vs placebo was 0.35 (95% confidence interval, 0.13–0.93) in patients with ascites fluid protein concentrations <15 g/L and 1.39 (95% confidence interval, 0.42–4.57) in patients with ascites fluid protein concentrations ≥15 g/L. Norfloxacin significantly decreased the incidence of any and Gram-negative bacterial infections without increasing infections caused by Clostridium difficile or multiresistant bacteria. Conclusions: In a randomized controlled trial of patients with advanced cirrhosis without recent fluoroquinolone therapy, norfloxacin did not reduce 6-month mortality, estimated by the Kaplan–Meier method. Norfloxacin, however, appears to increase survival of patients with low ascites fluid protein concentrations. ClinicalTrials.gov ID: NCT01037959.
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hal-04431063 , version 1 (14-02-2024)

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Paternité - Pas d'utilisation commerciale - Pas de modification

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Richard Moreau, Laure Elkrief, Christophe Bureau, Jean-Marc Perarnau, Thierry Thevenot, et al.. Effects of Long-term Norfloxacin Therapy in Patients with Advanced Cirrhosis.. Gastroenterology, 2018, Gastroenterology, 155, pp.1816-1827.e9. ⟨10.1053/j.gastro.2018.08.026⟩. ⟨hal-04431063⟩
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