Vol.63 No.6 November 2015

A multicenter retrospective analysis regarding the clinical safety and efficacy of the post-approval meropenem dose in Japanese patients

Yukihiro Hamada^1,2,20), Takashi Niwa^3,20), Yuichi Muraki^4,20), Satoshi Aoyama^5,20), Hidechika Ueda^6,20), Masami Okudaira^7,20), Masao Kimura^8,20), Yoshikazu Kobayashi^9,20), Arufumi Shiota^10,20), Tomoyuki Hirashita^11,20), Katsuaki Honda^12,20), Hiroki Mase^13,20), Tomoko Matsuoka^14,20), Takahiro Mochizuki^15,20), Akiya Mori^16,20), Toshiya Katayama^17,20), Takeshi Mori^18,20) and Hiroshige Mikamo^18,19)

¹⁾Department of Infection Control and Prevention and Pharmacy, Aichi Medical University Hospital School of Medicine, 1-1 Yazakokarimata, Nagakute, Aichi, Japan
²⁾Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT, USA
³⁾Department of Pharmacy, Gifu University Hospital
⁴⁾Department of Pharmacy, Mie University Hospital
⁵⁾Department of Pharmacy, Gifu Municipal Hospital
⁶⁾Department of Pharmacy, Takayama Red Cross Hospital
⁷⁾Department of Infection Control and Prevention, Anjo Kosei Hospital
⁸⁾Division of Pharmacy, Suzuka Kaisei Hospital
⁹⁾Department of Pharmacy, Tokai Municipal Hospital
¹⁰⁾Department of Pharmacy, and Infection Control and Prevention, Nagoya City University Hospital
¹¹⁾Department of Pharmacy, Gifu Prefectural General Medical Center
¹²⁾Department of Pharmacy, Seirei Hamamatsu General Hospital
¹³⁾Department of Pharmacy, National Center for Geriatrics and Gerontology
¹⁴⁾Department of Pharmacy, Ogaki Municipal Hospital
¹⁵⁾Department of Pharmacy, Shizuoka Cancer Center
¹⁶⁾Department of Pharmacy, JA Mie Suzuka General Hospital
¹⁷⁾Department of Pharmacy, Japan Community Health Care Organization Yokkaichi Hazu Medical Center
¹⁸⁾Department of Infection Control and Prevention, Aichi Medical University Hospital School of Medicine
¹⁹⁾Department of Clinical Infectious Diseases, Aichi Medical University Graduate School of Medicine
²⁰⁾Tokai Regional Infection Control Study Group (TRICSG)

Abstract

The post-approval dose of meropenem (MEPM), namely ≥3 g daily, is widely used for severe or refractory infectious diseases in Japan. However, evidence for the safety and efficacy of the post-approval dose in MEPM therapy remains insufficient. In a multicenter retrospective analysis, we compared patient backgrounds and the safety and efficacy of high-dose MEPM therapy with those patients who received the pre-approval MEPM therapy dose for severe or refractory infectious diseases.
Our final study comprised 383 cases; 231 cases in which the post-approval dose of MEPM was given versus 152 cases of the pre-approval dose of less than 3 g daily. The safety rates were 12.1% and 9.9% (p=0.49) and the clinical efficacy rates were 87.0% and 75.0% (p<0.01), respectively. The most frequent adverse event was hepatopathy but overall, severe adverse effects were not observed.
These findings suggest that an MEPM dose larger than 3 g daily is a useful and tolerable therapy in Japanese infectious patients.

Key word

meropenem, safety, efficacy, multicenter retrospective analysis

Received

March 27, 2015

Accepted

July 14, 2015

Jpn. J. Chemother. 63 (6): 560-567, 2015