Clinical study on levofloxacin in the field of internal medicine

Atsushi Saito, Yoshiteru Shigeno, Yuei Irabu, Hiroshi Fukuhara, Akira Saito, Masumi Tomizawa, Ichiro Nakayama, Yohmei Hiraga, Mitsuhide Ohmichi, Kazuo Takebe, Masashi Tamura, Kazuki Konishi, Yoshiaki Mori, Akio Mizuno, Akiho Obara, Tamotsu Takishima, Yasuo Tanno, Masakichi Motomiya, Akira Watanabe, Yushi NakaiJun ichi Saito, Kiyoshi Konno, Satoshi Shindo, Kosaku Nagai, Kazunao Niizuma, Kotaro Oizumi, Masataka Katsu, Hiroshi Hirose, Masatoshi Ishii, Jingoro Shimada, Kohya Shiba, Masaki Yoshida, Osamu Sakai, Hiroichi Tanimoto, Kazuo Ohara, Kihachiro Shimizu, Kyoichi Totsuka, Junichi Katahira, Kaoru Shimada, Hazime Goto, Shinichi Oka, Yoshihisa Ogata, Takashi Inamatsu, Yoshishige Masuda, Hiroshi Sakamoto, Fumiko Kojima, Makoto Kodaira, Yasuyuki Sano, Yasufumi Miyamoto, Hiroyuki Kobayashi, Hideo Ikemoto, Takeshi Mori, Masayoshi Inagaki, Koichiro Nakata, Yoshitaka Nakamori, Tatsuo Nakatani, Takeshi Kawai, Mitsuo Honma, Junzaburo Kabe, Koichiro Kudo, Hitoshi Arioka, Masaru Koyama, Harumi Shishido, Norio Kikuchi, Hidetoshi Igari, Hiroshi Tabeta, Shigeki Odagiri, Kaneo Suzuki, Hiroshi Takahashi, Kenichi Takahashi, Yasuhiko Ashikari, Eri Hagiwara, Yasutsugu Amano, Akira Shohji, Fumio Matsumoto, Takero Imai, Shoichiro Irimajiri, Yasuo Matsuoka, Mitsuo Obana, Masaaki Arakawa, Kouichi Wada, Hiroki Tukada, Takashi Kawashima, Osamu Sekine, Yasutoshi Suzuki, Katsuji Uno, Nobuki Aoki, Atsuhiko Sato, Masatoshi Iwata, Kingo Chida, Izumi Shichi, Hirokazu Okano, Masahiko Okano, Masami Taniguchi, Tatsuo Satake, Kenzo Takagi, Kenichi Yamaki, Hiroyuki Miyatake, Toshiyuki Yamamoto, Kanzo Suzuki, Satoru Adachi, Toru Matsuura, Fumiyuki Kuze, Tatsuyoshi Ikeue, Katsuhiro Suzuki, Kenji Bando, Masaru Chiba, Yoshinori Hasegawa, Ryuhei Nawata, Nobuo Inaba, Akira Kagioka, Mitsuo Hase, Eiro Tsubura, Masaru Nakagawa, Susumu Kishimoto, Nakaaki Osawa, Iwao Igarashi, Kiyoshi Komuta, Keiji Maeda, Mitsunori Sakatani, Toshio Sone, Yasutake Takahashi, Tatsuya Okada, Mitsumasa Ogawara, Kazuya Higashino, Takashi Nakano, Fumio Miki, Shigenori Nakashima, Atsushi Yasukawa, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Rinzo Soejima, Niro Okimoto, Masaru Sumi, Toshiharu Matsushima, Yoshihiko Tano, Takao Sasaki, Yukio Matsumoto, Yuji Sugimoto, Michio Yamakido, Kenji Hasegawa, Osamu Kurimura, Yoshiro Sawae, Koji Takagi, Nobuyuki Shimono, Atsushi Shinoda, Tsuneo Ishibashi, Masahiro Takamoto, Hozumi Yamada, Osamu Kato, Yosuke Aoki, Shigetaka Kuroki, Kohei Hara, Hironobu Koga, Kiyoyasu Fukushima, Hisasuke Nakamura, Tetsuro Kanda, Miyako Ishiguro, Takakazu Kiya, Shiro Kusano, Keizo Matsumoto, Hironori Masaki, Hirofumi Tanaka, Masaru Nasu, Yoichiro Goto, Hiroyuki Nagai, Toru Yamasaki, Takayoshi Tashiro, Shinobu Takenaka, Kiyoshi Shima, Mitsuo Kaku, Kazuyuki Sugawara, Keizo Yamaguchi

Research output: Contribution to journalArticle

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Abstract

Levofloxacin (LVFX), an optical isomer of ofloxacin (OFLX), is twice as potent as OFLX against gram-positive and gram-negative bacteria such as Haemophilus influenzae, Streptococcus pneumoniae and Pseudomonas aeruginosa, while it has been shown to be as safe as OFLX in animal experiments. Phase 1 study showed that the pharmacokinetics of LVFX were similar to those of OFLX. We carried out a multicenter collaborative trial at 69 institutions to determine the clinical efficacy and safety of LVFX in the field of internal medicine, mainly in the treatment of respiratory tract infections. LVFX was orally administered to 463 patients in daily doses of 200 mg to 600 mg for 7 to 14 consecutive days. Out of the total patients enrolled, the clinical efficacy was evaluated in 423 patients and was 84.9% (321/378) against respiratory tract infections, 78.8% (26/33) against urinary tract infections, 100% (9/9) against infectious enteritis and 100% (3/3) against other infections. As for respiratory tract infections, the efficacy rate was 90.6% (77/85) for pharyngitis and tonsillitis, 80.2% (174/217) for infectious exacerbation of chronic respiratory disease and 91.8% (67/73) for pneumonia. The efficacy rate, as a function of the daily dose, was 79.2% (38/48) with 100mg b.i.d., 85.5% (253/296) with 100mg t.i.d., 87.7% (50/57) with 200mg t.i.d., and 81.8% (18/22) with other dose regimens. The bacteriological response was evaluated in 179 patients and showed an eradication rate of 77.4% (123/159) for monomicrobial infections and 40.0% (8/20) for polymicrobial infections. The MIC was determined for 78 strains, and the eradication rate was 78.9% (56/71) for strains with an MIC value of 1.56 µg/ml or lower and 0.0% (0/7) for strains with an MIC value of 3.13 µg/ml or higher. Out of 454 patients, clinical adverse reactions were recorded in 17 (3.7%), consisting of gastrointestinal disorder in 9, neurogenic symptoms in 7 and other symptoms in 1. Abnormal laboratory findings were recorded in 41 (10.0%) out of 409 patients, the main item being elevation of the eosinophil count and the transaminase level. None of them were serious. Based on the above results, we concluded that LVFX is a useful antibacterial agent for the treatment of infections in the field of internal medicine, mainly respiratory tract infections.

Original languageEnglish
Pages (from-to)147-169
Number of pages23
JournalChemotherapy
Volume40
DOIs
Publication statusPublished - May 1992

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All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)
  • Infectious Diseases
  • Pharmacology
  • Drug Discovery
  • Oncology

Cite this

Saito, A., Shigeno, Y., Irabu, Y., Fukuhara, H., Saito, A., Tomizawa, M., ... Yamaguchi, K. (1992). Clinical study on levofloxacin in the field of internal medicine. Chemotherapy, 40, 147-169. https://doi.org/10.11250/chemotherapy1953.40.Supplement3_147