Efficacy and safety of meropenem (3 g daily) in Japanese patients with refractory respiratory infections.

INTRODUCTION

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.

OBJECTIVES

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.

CONCLUSION

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.