A double-blind comparative study of gatifloxacin and levofloxacin in pneumonia

A. Saito, T. Koike, K. Taneichi, T. Takeda, K. Takeuchi, M. Ohmichi, H. Sasaki, H. Inoue, M. Sato, M. Ohura, Y. Aoyama, M. Yoshida, K. Takeuchi, N. Miyamoto, A. Watanabe, N. Aso, H. Takahashi, Y. Sano, Y. Arai, K. NakataT. Nakatani, H. Goto, H. Kobayashi, H. Miura, H. Shishido, K. Sato, F. Matsumoto, I. Sakurai, T. Ohkubo, H. Ikeda, M. Nishikawa, M. Matsumura, M. Sato, S. Takagi, M. Tsubakihara, T. Takii, H. Numata, N. Aoki, O. Sekine, Y. Suzuki, M. Matsuda, K. Wada, K. Fuse, F. Iwata, S. Hoshino, A. Iwashima, A. Sato, K. Chida, K. Yagi, T. Sano, H. Suganuma, R. Tamura, N. Inui, M. Iwata, Y. Nakamura, S. Oda, K. Yanase, N. Kubo, K. Ueno, K. Shimokata, M. Yamamoto, M. Ando, Y. Totani, S. Sakai, T. Murate, S. Yamori, Y. Iinuma, N. Takagi, M. Iwata, Y. Sugino, K. Takagi, M. Tano, M. Iwata, A. Nagata, M. Ogawa, Y. Noda, H. Gonda, N. Ohishi, F. Kuze, N. Ikeda, T. Kurasawa, K. Nakatani, T. Ikeda, K. Bando, N. Ishikawa, M. Taniguchi, Y. Mochizuki, T. Kawamura, F. Miki, N. Narita, K. Mikasa, T. Sasaki, Y. Matsumoto, R. Soejima, T. Matsushima, Y. Niki, K. Hashiguchi, Y. Kobashi, N. Okimoto

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Abstract

This randomized, double-blind clinical study was conducted to compare the clinical efficacy, safety, and usefulness of gatifloxacin (GFLX, AM- 1155), a new 8-methoxyquinolone, with that of levofloxacin (LVFX) in pneumonia. GFLX was administered at an oral dose of 200 mg, twice a day, and LVFX at an oral dose of 100 mg, three times a day, for 14 days, and the following results were obtained: 1. Of the total of 226 patients enrolled, 200 (GFLX group: 100, LVFX group: 100) were eligible for evaluation of clinical efficacy. 2. The clinical efficacy rate was 98.0% (98/100) in the GFLX group, and 95.0% (95/100) in the LVFX group, and thus high efficacy was shown in both groups. The clinical equivalency of GFLX to LVFX was confirmed at Δ=10%, and the difference between the groups was not significant. 3. The bacteriological elimination rate was 100% (39/39) in the GFLX group and 87.5% (21/24) in the LVFX group, with no significant difference. 4. Side effects were noted in 10.4% (12/115) in the GFLX group and in 4.5% (5/110) in the LVFX group, and the difference between the two groups was not significant. The major events were diarrhea, sleepiness and dizziness. 5. Abnormal laboratory findings were observed in 14.2% (15/106) in the GFLX group and in 19.6% (21/107) in the LVFX group, and the difference between the two groups was not significant. The major events were mild elevations of transaminases. 6. The safety rate ('safe' in overall safety) was 76.4% (84/110) in the GFLX group and 76.6% (82/107) in the LVFX group, with no significant difference. 7. The usefulness rate (markedly useful + useful) was 92.9% (92/99) in the GFLX group and 89.8% (88/98) in the LVFX group, and the difference between the two groups was not significant. The clinical equivalency of GFLX to LVFX was confirmed at Δ=10%. The bacteriological elimination rate was 100% in the GFLX group. There were no significant differences between the two groups in the incidence of side effects or abnormal laboratory findings. These results indicate that GFLX is a highly effective drug for the treatment of community- acquired pneumonia (bacterial, mycoplasmal, and chlamydial pneumonia).

Original languageEnglish
Pages (from-to)712-733
Number of pages22
JournalJapanese Journal of Chemotherapy
Volume47
Issue number11
Publication statusPublished - 1999
Externally publishedYes

Keywords

  • Gatifloxacin
  • Levofloxacin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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