Vol.53 No.S-1 July 2005

Double-blind, controlled study to evaluate safety and efficacy of doripenem and meropenem in patients with complicated urinary tract infection

Sadao Kamidono¹⁾, Soichi Arakawa¹⁾, Takaoki Hirose²⁾, Hiroichi Kishi³⁾, Masaya Tsugawa⁴⁾, Tetsuro Matsumoto⁵⁾, Masatoshi Tanaka⁶⁾, Motoshi Kawahara⁷⁾, Mitsuyoshi Nakashima⁸⁾, Nobumasa Kataoka⁹⁾ and Jingoro Shimada¹⁰⁾

¹⁾Department of Urology, Kobe University, School of Medicine,
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
²⁾Department of Urology, Hokkaido Social Insurance Hospital
³⁾Department of Urology, International Medical Center of Japan
(Present: Yokosuka Kyosai Hospital)
⁴⁾Department of Urology, Okayama University Medical School
(Present: Department of Urology, Okayama Citizens'Hospital)
⁵⁾Department of Urology, University of Occupational and Environmental Health
⁶⁾Department of Urology, Faculty of Medicine, Kyushu University
(Present: Department of Urology, Fukuoka University, School of Medicine)
⁷⁾Department of Urology, Faculty of Medicine, Kagoshima University
⁸⁾Hamamatsu Institute of Clinical Pharmacology and Therapeutics
⁹⁾Kobe University, School of Medicine, Faculty of Health Sciences
¹⁰⁾St. Marianna University School of Medicine

Abstract

We conducted a double-blind, controlled study to evaluate the safety and efficacy of doripenem (DRPM), a new carbapenem antibiotic for injection, in patients with complicated urinary tract infection with meropenem (MEPM) set as the control drug. Subjects were in-patients aged 20 to 79 years shown to have pyuria of at least 5 WBCs/hpf and bacteriuria of at least 10⁴ CFU/mL.
DRPM was administered at 250 mg b.i.d. and MEPM at 500 mg b.i.d. for 5 consecutive days. Based on the criteria proposed by the Japanese UTI Committee, DRPM and MEPM were evaluated for efficacy. Overall efficacy was 96.1% (73/76) in the DRPM group and 88.6% (70/79) in the MEPM group, demonstrating the non inferiority of DRPM to MEPM (Pn=0.0003). The bacteriological response was 95.9% (94/98) in the DRPM group and 96.2% (101/105) in the MEPM group, demonstrating the non inferiority of DRPM to MEPM (p=0.0036). For both gram-negative and gram-positive bacteria, the bacteriological response exceeded 95% in both groups. Clinical efficacy judged by attending urologists was 93.4% (71/76) in the DRPM group and 92.4% (73/79) in the MEPM group, demonstrating the non inferiority of DRPM to MEPM (Pn=0.0098).
For safety, the incidence of adverse drug reactions (symptoms) was 4.3% (4/92) in the DRPM group and 4.0% (4/101) in the MEPM group. The incidence of adverse drug reactions (abnormal laboratory findings) was 17.6% (16/91) in the DRPM group and 22.2% (22/99) in the MEPM group, with no significant difference between groups (Pe=1.0000, 0.4709).
These results show that DRPM at 250 mg b.i.d. is useful for treating patients with complicated urinary tract infection, and equivalent to MEPM at 500 mg b.i.d..

Key word

doripenem, complication, urinary tract infection, double-blind study, meropenem

Received

January 24, 2005

Accepted

February 24, 2005

Jpn. J. Chemother. 53 (S-1): 244-259, 2005