title: Efficacy and safety of meropenem (3 g daily) in Japanese patients with refractory respiratory infections.
abstract: BACKGROUND
  Pneumonia is the third leading cause of mortality in Japan. In 2011, the use of meropenem (MEPM) at 3 g daily was approved to treat refractory infections in Japan. However, little has been reported on the clinical efficacy and safety of this regimen in Japanese patients with refractory infections.
  
  
  OBJECTIVE
  This study prospectively assessed the clinical efficacy and safety of MEPM (3 g daily) in Japanese patients with refractory pneumonia and/or intrapleural infections.
  
  
  METHODS
  This study was performed at our university hospital and affiliated hospitals. The plasma concentrations of MEPM before and one and four hours after MEPM administration were also evaluated.
  
  
  RESULTS
  A total of 48 patients were enrolled for the efficacy and safety evaluations. The response rate to MEPM (3 g daily) treatment was 90.9% (40/44). Adverse drug reactions were observed in 17 of the 48 patients (20.8%), and all improved after the cessation of MEPM. The plasma MEPM concentration one hour after administering 1 g of MEPM was 44.9 ± 12.0 μg/ml. A pharmacokinetic analysis revealed that the percentage of time above the MIC/24 h for an MIC of 4 μg/ml or 8 μg/ml was more than 50% in 12 of 13 (92%) and in nine of the 13 patients (69%), respectively, indicating sufficient efficacy of 3 g daily of MEPM.
  
  
  CONCLUSIONS
  Treatment with MEPM (3 g daily) in Japanese patients with refractory pneumonia and/or intrapleural infections is effective, with sufficient plasma concentrations of MEPM, and the treatment has a relatively good safety profile.
authors.affiliation: Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan.
authors.forename: Toshinori
authors.initials: T
authors.lastname: Kawanami
authors.affiliation: Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan. Electronic address: hmukae@med.uoeh-u.ac.jp.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mukae
authors.affiliation: Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Noguchi
authors.affiliation: Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Yamasaki
authors.affiliation: Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan.
authors.forename: Kentarou
authors.initials: K
authors.lastname: Akata
authors.affiliation: Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ishimoto
authors.affiliation: Department of Clinical Pharmaceutics, Doshisha Women's College of Liberal Arts, Japan.
authors.forename: Kana
authors.initials: K
authors.lastname: Matsumoto
authors.affiliation: Department of Clinical Pharmaceutics, Doshisha Women's College of Liberal Arts, Japan.
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Morita
authors.affiliation: Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yatera
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood; D001424:Bacterial Infections / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D000077731:Meropenem; D008875:Middle Aged; D011446:Prospective Studies; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D013845:Thienamycins / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood
chemical_list: D000900:Anti-Bacterial Agents; D013845:Thienamycins; D000077731:Meropenem
keywords: Efficacy and safety; High dose; Meropenem; Plasma concentration; Respiratory infection