Vol.53 No.S-1 July 2005

Comparative study of doripenem and meropenem in respiratory infections Phase III double-blind comparative study

Atsushi Saito¹⁾, Akira Watanabe²⁾, Koichiro Nakata³⁾, Shigeki Odagiri⁴⁾, Nobuki Aoki⁵⁾, Toshiharu Matsushima⁶⁾, Shigeru Kohno⁷⁾, Masaru Nasu⁸⁾, Mitsuyoshi Nakashima⁹⁾, Keizo Yamaguchi¹⁰⁾ and Jingoro Shimada¹¹⁾

¹⁾Department of Medicine and Therapeutics, Control and Prevention of Infectious Diseases,
Faculty of Medicine, University of the Ryukyus, 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
²⁾Department of Respiratory Medicine, Division of Cancer Control,
Institute of Development, Aging and Cancer, Tohoku University
³⁾Department of Internal Medicine, Toranomon Hospital
(Present: Department of Respiratory Diseases, Toho University School of Medicine)
⁴⁾Department of Respiratory Diseases, Kanagawa Prefectural Cardiovascular and
Respiratory Diseases Center Hospital (Present: Odagiri Respiratory Disease Clinic)
⁵⁾Department of Internal Medicine, Shinrakuen Hospital
⁶⁾Division of Respiratory Diseases, Department of Internal Medicine, Kawasaki Medical School
(Present: Kurashiki Daiichi Hospital)
⁷⁾Division of Molecular and Clinical Microbiology, Department of Microbiology and Immunology,
Nagasaki University Graduate School of Medical Sciences
⁸⁾Division of Pathogenesis and Disease Control, Department of Infectious Diseases,
Oita University Faculty of Medicine
⁹⁾Hamamatsu Institute of Clinical Pharmacology and Therapeutics
¹⁰⁾Department of Microbiology, Toho University School of Medicine
¹¹⁾St. Marianna University School of Medicine

Abstract

We evaluated the clinical efficacy and safety of doripenem (DRPM), a new carbapenem for injection, in respiratory infection in a randomized, double-blind, 2-group parallel-group, noninferiority comparative study with meropenem (MEPM). The dosage of DRPM was 250 mg 2 times daily for 7 days (DRPM group) and that of MEPM 500 mg 2 times daily for 7 days (MEPM). Results as follows:
1. Clinical efficacy
Subjects evaluated for clinical efficacy numbered 193. Clinical efficacy in the per-protocol-set was 92.7% (89/96) in the DRPM group 90.7% (88/97) in the MEPM group. DRPM thus demonstrated noninferiority to MEPM.
2. Bacteriological effect
About half of the subjects, or 91, evaluated for clinical efficacy were further evaluated for bacteriological effects. Eradication was 86.0% (37/43) in the DRPM group and 95.8% (46/48) in the MEPM group, no significant difference in eradication between groups.
3. Safety
Subjects were evaluated for nonlaboratory adverse drug reactions numbered 218. The incidence of nonlaboratory adverse drug reactions was 8.1% (9/111) in the DRPM group and 6.5% (7/107) in the MEPM group. Of these 217 were further evaluated for laboratory adverse drug reactions. The incidence of laboratory adverse drug reactions was 23.4% (26/111) in the DRPM group and 25.5% (27/106) in the MEPM group, indicating no significant difference in nonlaboratory or laboratory adverse drug reaction incidence.
DRPM (250 mg 2 times daily for 7 days) is thus considered to have a novel therapeutic effect comparable to MEPM (500 mg 2 times daily for 7 days).

Key word

doripenem, meropenem, respiratory tract infection, double-blind study

Received

January 24, 2005

Accepted

March 17, 2005

Jpn. J. Chemother. 53 (S-1): 185-204, 2005