A comparative study of biapenem and imipemem/cilastatin in lower respiratory infections

F. Matsumoto, M. Inoue, I. Sakurai, Y. Ishida, T. Osonoi, H. Itoh, H. Inoue, K. Yamauchi, K. Shirato, I. Ohno, M. Sakamoto, T. Nukiwa, A. Watanabe, Y. Nakai, S. Shoji, Y. Honda, K. Niizuma, Y. Anzai, Y. Anazawa, N. AsoH. Takahashi, S. Nakayama, K. Yanase, M. Nakamura, T. Toyoda, K. Dote, A. Tsunami, K. Wada, F. Iwata, Y. Shimazu, K. Fujimori, N. Aoki, Y. Ishizuka, O. Sekine, Y. Suzuki, K. Kaneko, K. Shimada, K. Nakano, Y. Sano, C. Ogawa, Y. Toh, O. Sakai, T. Hosoya, K. Shiba, M. Yoshida, K. Yoshikawa, K. Kasai, T. Kimura, K. Hirano, M. Fukakusa, K. Watanabe, H. Isonuma, K. Nakata, H. Narui, T. Nakatani, S. Honma, E. Tsuboi, K. Kishi, M. Kawabata, K. Kudo, A. Kawana, H. Miyashita, Y. Ono, H. Nishiya, H. Kobayashi, S. Sakayori, H. Miura, S. Takayasu, S. Irimajiri, Y. Matsuoka, M. Obana, T. Okubo, H. Ikeda, M. Nishikawa, K. Tani, H. Hasegawa, H. Sakamoto, H. Numata, M. Hashimoto, M. Matsumura, M. Satoh, M. Nakamura, Y. Hirai, T. Nakamura, T. Iwabuchi, S. Odagiri, K. Suzuki, Y. Watanuki, H. Takahashi, K. Takahashi, Y. Yoshiike, T. Ogura, M. Toda, H. Nishiyama, A. Shoji, Y. Ishimaru, T. Yoshimi, H. Nakanura, A. Sato

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    Abstract

    The clinical efficacy, safety and usefulness of biapenem (BIPM), a carbapenem antibiotic for injection, were evaluated in lower respiratory infections in a comparative study with imipenem/cilasstatin (IPM/CS). BIPM and IPM/CS were administered by intravenous drip infusion at a dose of 300 mg twice daily and 500 mg/500 mg twice daily. The duration of treatment was within 14 days. The following results were obtained. 1. A total of 214 cases were enrolled in this study, consisting of 103 in the BIPM group and 111 in the IPM/CS group. The clinical efficacy was evaluated in 88 of the BIPM group and 93 of the IPM/CS group, the overall safety was evaluated in 101 of the BIPM group and 110 of the IPM/CS group, and the usefulness was evaluated in 89 of the BIPM group and 101 of the IPM/CS group. 2. The clinical efficacy rates were 93.2% (82/88) in the BIPM group and 91.4% (85/93) in the IPM/CS group. The 90% confidence interval of the difference between the two groups was -5.8% to 9.4%, and the clinical non inferiority of BIPM to IPM/CS was demonstrated. For the evaluation of early onset after 3 days of treatment, the early clinical efficacy rates were 84.1% (74/88) in the BIPM group and 76.3% (71/93) in the IPM/CS group, with no significant difference between the two groups. 3. The bacteriological eradication rates were 89.1% (41/46) in the BIPM group and 97.5% (39/40) in the IPM/CS group, with no significant difference between the two groups. 4. Side effects were observed at a rate of 1.9% (2/103)in the BIPM group and 6.3% (7/111) in the IPM/CS group, with no significant difference between the two groups. Abnormal laboratory findings were observed at a rate of 26.2% (27/103) in the BIPM group and 43.2% (48/111) in the IPM/CS group, with significant difference between the two groups. The safety rates were 98.0% (99/101) in the BIPM group and 96.4% (106/110) in the IPM/CS group, with no significant difference between the two groups. 5. The usefulness rates were 88.8% (79/89) in the BIPM group and 81.2% (82/101) in the IPM/CS group, with no significant difference between the two groups. These results demonstrate that BIPM is a useful drug for the treatment of lower respiratory tract infections.

    Original languageEnglish
    Pages (from-to)45-67
    Number of pages23
    JournalJapanese Journal of Chemotherapy
    Volume48
    Issue number1
    Publication statusPublished - 2000

    Keywords

    • Biapenem
    • Imipenem/cilastatin

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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