Clarithromycin-controlled randomized double-blind studies of azithromycin for treatment of pneumonia

Hiroyuki Kobayashi, Susumu Sakayori, Takao Koike, Masaya Mukai, Yohmei Hiraga, Mitsuhide Ohmichi, Fumio Nakanishi, Yohsei Inoue, Kazuki Konishi, Toshihiro Nukiwa, Akira Watanabe, Yushi Nakai, Yoshihiro Honda, Kazunao Niizuma, Akira Ohishi, Kohtaro Kaneko, Osamu Sakai, Kouya Shiba, Kaoru Shimada, Shinichi OkaYasuyuki Sano, Atsuko Murakami, Hajime Goto, Kazumi Yuasa, Izumi Hayashi, Masaru Koyama, Mamoru Chida, Koichiro Nakata, Tatsuo Nakatani, Eiyasu Tsuboi, Yoshitaka Nakamori, Yoshihiro Miyashita, Shigeki Odagiri, Kaneo Suzuki, Yoshihiro Hirai, Masashi Akahori, Shoichiro Irimajiri, Mitsuo Obana, Takao Okubo, Hirotada Ikeda, Hiroshi Matsumoto, Masanori Nishikawa, Masaaki Arakawa, Koichi Wada, Hiroki Tsukada, Sigeyuki Hoshino, Akira Iwashima, Fumihide Iwata, Nobuki Aoki, Osamu Sekine, Yasutoshi Suzuki, Shigeo Takizawa, Shoko Tagami, Atsuhiko Sato, Ryoji Tamura, Jun Sato, Hideki Suganuma, Masatoshi Iwata, Masashi Kobayashi, Satoshi Kawasaki, Yasuo Yamada, Ikuji Usami, Yoshimitsu Hayashi, Toshiyuki Yamamoto, Toshinobu Yamamoto, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Fumio Miki, Eiro Tsubura, Takehiko Kobayashi, Rinzo Soejima, Yoshihito Niki, Niro Okimoto, Toshiharu Matsushima, Yoshihiko Tano, Susumu Kawahara, Takao Sasaki, Yukio Matsumoto, Michio Yamakido, Naoki Yamaoka, Yoshiro Sawae, Yukio Kumagai, Masamitsu Kido, Yoshihiko Nikaido, Kikuo Arakawa, Kenji Kohno, Seiji Takeda, Ichiro Tatara, Tamaki Nanjo, Kotaro Oizumi, Toru Rikimaru, Tsuneaki Shiraishi, Yoshiyuki Mitsutake, Tsuneo Ishibashi, Masahiro Takamoto, Yoshinari Kitahara, Kohei Hara, Shigeru Kohno, Hironobu Koga, Hideo Mashimoto, Jun Araki, Shigefumi Maesaki, Keizo Matsumoto, Tsuyoshi Nagatake, Yoshiaki Utsunomiya, Kenji Kawakami, Kiyoshi Shima, Shinobu Takenaka, Masaru Nasu, Jun Goto, Kazuhiro Hirai, Atsushi Saito, Hiroshi Fukuhara, Katsuyoshi Shimoji, Mitsuyoshi Nakashima

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    Abstract

    The efficacy, safety and usefulness of a newly developed oral macrolide antibiotic, azithromycin (AZM), for treatment of pneumonia were investigated using a randomized double blind trial with clarithromycin (CAM) as the control drug. AZM was administered at a dose of 500 mg (titer) once a day for 3 days, and CAM was administered at a dose of 200 mg (titer) twice a day for 14 days. The following results were obtained: 1. The efficacy rate (proportion of patients in whom clinical efficacy was excellent or good) was determined in a total of 122 patients in whom clinical efficacy could be analyzed, out of a total of 163 patients to whom the drug had been administered. The rate was 98. 3% (58/59) in the AZM group, and 90.5% (57/63) in the CAM group. There was no significant difference between the two groups, and the clinical equivalency of AZM to CAM was demonstrated (Δ=10%, p< 0.001). 2. The elimination rate of isolated bacteria was 86.7% (13/15) in the AZM group, and 88.2% (15/17) in the CAM group (no significant difference). 3. The incidences of adverse reactions were 4.1% (3/74), in the AZM group, and 6.7% (5/75), in the CAM group (no significant difference). 4. The incidences of abnormal changes in clinical laboratory test values were 20.8% (15/72). in the AZM group, and 21.4% (15/70), in the CAM group (no significant difference). 5. The rate of safety (proportion of patients in whom the drug was not problematic) was determined in 144 patients in whom the degree of general safety could be analyzed. The rate was 77.8% (56/72) in the AZM group, and 73.6% (53/72) in the CAM group (no significant difference). 6. The rate of usefulness (proportion of patients in whom the drug was extremely useful or useful) was determined in 121 patients in whom usefulness could be analyzed. The rate was 94.9% (56/59) in the AZM group, and 87.1%(54/62) in the CAM group (no significant difference). These results suggest that AZM is a very useful drug, comparable to CAM, for the treatment of pneumonia.

    Original languageEnglish
    Pages (from-to)757-774
    Number of pages18
    JournalJapanese Journal of Chemotherapy
    Volume43
    Issue number8
    DOIs
    Publication statusPublished - 1995

    Keywords

    • azithromycin
    • clarithromycin
    • comparative study
    • pneumonia

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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  • Cite this

    Kobayashi, H., Sakayori, S., Koike, T., Mukai, M., Hiraga, Y., Ohmichi, M., Nakanishi, F., Inoue, Y., Konishi, K., Nukiwa, T., Watanabe, A., Nakai, Y., Honda, Y., Niizuma, K., Ohishi, A., Kaneko, K., Sakai, O., Shiba, K., Shimada, K., ... Nakashima, M. (1995). Clarithromycin-controlled randomized double-blind studies of azithromycin for treatment of pneumonia. Japanese Journal of Chemotherapy, 43(8), 757-774. https://doi.org/10.11250/chemotherapy1995.43.757