TY - JOUR
T1 - Comparative study of doripenem and meropenem in respiratory infections. Phase III double-blind comparative study
AU - Saito, Atsushi
AU - Watanabe, Akira
AU - Nakata, Koichiro
AU - Odagiri, Shigeki
AU - Aoki, Nobuki
AU - Matsushima, Toshiharu
AU - Kohno, Shigeru
AU - Nasu, Masaru
AU - Nakashima, Mitsuyoshi
AU - Yamaguchi, Keizo
AU - Shimada, Jingoro
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2005/7
Y1 - 2005/7
N2 - 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 ing 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).
AB - 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 ing 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).
KW - Doripenem
KW - Double-blind study
KW - Meropenem
KW - Respiratory tract infection
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M3 - Article
AN - SCOPUS:23244445008
VL - 53
SP - 185
EP - 204
JO - Japanese Journal of Chemotherapy
JF - Japanese Journal of Chemotherapy
SN - 1340-7007
IS - SUPPL. 1
ER -