Comparative grepafloxacin dose-finding study in the treatment of chronic respiratory tract infection

Hiroyuki Kobayashi, Hiroaki Takeda, Susumu Sakayori, Akira Saito, Ichiro Nakayama, Masumi Tomizawa, Yohmei Hiraga, Mitsuhide Ohmichi, Kenji Kataoka, Masashi Tamura, Kazuo Obara, Kazuki Konishi, Hitoshi Kobayashi, Akira Watanabe, Shigeo Takizawa, Mikae Nakamura, Kaoru Shimada, Yasuyuki Sano, Yasufumi Miyamoto, Norio KikuchiOsamu Sakai, Koya Shiba, Shinichi Tanimoto, Koichiro Nakata, Tatsuo Nakatani, Harumi Shishido, Hideaki Nagai, Jingoro Shimada, Seiji Hori, Fumio Matsumoto, Takeo Imai, Shigeki Odagiri, Hiroshi Takahashi, Kenichi Takahashi, Yoshihiro Hirai, Akira Syoji, Takashi Sakuma, Takao Okubo, Hirotada Ikeda, Masaaki Arakawa, Koichi Wada, Fumihide Iwata, Nobuki Aoki, Osamu Sekine, Yasutoshi Suzuki, Teruya Yoshimi, Atsuhiko Sato, Kingo Chida, Takafumi Suda, Atsushi Yoshitomi, Takeshi Yagi, Toshihiko Takeuchi, Hidekazu Hanaki, Yasuo Yamada, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Fumio Miki, Rinzo Soejima, Niro Okimoto, Yoshihito Niki, Toshiharu Matsushima, Makoto Kimura, Michio Yamakido, Kenji Hasegawa, Kotaro Oizumi, Yoichiro Ichikawa, Naoto Tokunaga, Takeshi Araki, Kazuma Fujino, Kohei Hara, Shigeru Kohno, Mitsuo Kaku, Hironobu Koga, Naomi Ito, Keizo Matsumoto, Masakazu Takasugi, Hiroshi Watanabe, Masaru Nasu, Yoichiro Goto, Tohru Yamasaki, Jun Goto, Kazuo Kitagawa, Atsushi Saito, Yuei Irabu, Mitsuyoshi Nakashima, Koichi Deguchi

Research output: Contribution to journalArticlepeer-review

Abstract

A dose-comparison trial to establish the optimal dose of the new quinolone synthetic antibacterial agent grepafloxacin (GPFX, OPC-17116) in the treatment of respiratory infections was conducted in patients with chronic respiratory tract infection, using ofloxacin (OFLX) as the control drug. The efficacy, safety, and usefulness of GPFX 200 mg q. d. (Group L) were compared with GPFX 300 mg q. d. (Group H) by the double-blind method, and each dose of GPFX was compared with open-label treatment with OFLX 200 mg t. i. d. (Group 0). As a rule, treatment was continued for 14 days. It was judged that 121 of the 127 patients enrolled (37 in Group L, 41 in Group H, 43 in Group 0) were capable of being evaluated for efficacy. 1. Clinical efficacy: The clinical efficacy rate was 89.2% (33/37), 97.6% (40/41), and 88.4% (38/43) in Groups L, H, and 0, respectively. No statistically significant differences were observed among the 3 groups. 2. Bacteriological efficacy: The bacterial eradication rate was 75.0% (15/20), 93.3% (14/15), and 85.7% (18/21) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. 3. Safety assessments: In Groups L, H and 0, the incidence of adverse reactions was 2.6% (1/39), 7.3% (3/41) and 9.1% (4/44), respectively, and the incidence of abnormal laboratory findings was 5.1% (2/39), 5.1% (2/39), and 4.9% (2/41), respectively. There were no statistically significant differences in the incidence of adverse reactions or abnormal laboratory findings in the 3 groups. 4. Usefulness: The usefulness rate was 86.5% (32/37), 94.9% (37/39), and 85.4% (35/41) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. These findings demonstrated that 300 mg q. d. is the appropriate clinical dose of GPFX for the treatment of respiratory infections.

Original languageEnglish
Pages (from-to)439-441
Number of pages3
JournalJapanese Journal of Chemotherapy
Volume45
Issue number6
Publication statusPublished - 1997

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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