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. Nakata; T. 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

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

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

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 language	English
Pages (from-to)	712-733
Number of pages	22
Journal	Japanese Journal of Chemotherapy
Volume	47
Issue number	11
Publication status	Published - 1999
Externally published	Yes

Keywords

Gatifloxacin
Levofloxacin

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Cite this

Saito, A., Koike, T., Taneichi, K., Takeda, T., Takeuchi, K., Ohmichi, M., Sasaki, H., Inoue, H., Sato, M., Ohura, M., Aoyama, Y., Yoshida, M., Takeuchi, K., Miyamoto, N., Watanabe, A., Aso, N., Takahashi, H., Sano, Y., Arai, Y., ... Okimoto, N. (1999). A double-blind comparative study of gatifloxacin and levofloxacin in pneumonia. Japanese Journal of Chemotherapy, 47(11), 712-733.

Saito, A, Koike, T, Taneichi, K, Takeda, T, Takeuchi, K, Ohmichi, M, Sasaki, H, Inoue, H, Sato, M, Ohura, M, Aoyama, Y, Yoshida, M, Takeuchi, K, Miyamoto, N, Watanabe, A, Aso, N, Takahashi, H, Sano, Y, Arai, Y, Nakata, K, Nakatani, T, Goto, H, Kobayashi, H, Miura, H, Shishido, H, Sato, K, Matsumoto, F, Sakurai, I, Ohkubo, T, Ikeda, H, Nishikawa, M, Matsumura, M, Sato, M, Takagi, S, Tsubakihara, M, Takii, T, Numata, H, Aoki, N, Sekine, O, Suzuki, Y, Matsuda, M, Wada, K, Fuse, K, Iwata, F, Hoshino, S, Iwashima, A, Sato, A, Chida, K, Yagi, K, Sano, T, Suganuma, H, Tamura, R, Inui, N, Iwata, M, Nakamura, Y, Oda, S, Yanase, K, Kubo, N, Ueno, K, Shimokata, K, Yamamoto, M, Ando, M, Totani, Y, Sakai, S, Murate, T, Yamori, S, Iinuma, Y, Takagi, N, Iwata, M, Sugino, Y, Takagi, K, Tano, M, Iwata, M, Nagata, A, Ogawa, M, Noda, Y, Gonda, H, Ohishi, N, Kuze, F, Ikeda, N, Kurasawa, T, Nakatani, K, Ikeda, T, Bando, K, Ishikawa, N, Taniguchi, M, Mochizuki, Y, Kawamura, T, Miki, F, Narita, N, Mikasa, K, Sasaki, T, Matsumoto, Y, Soejima, R, Matsushima, T, Niki, Y, Hashiguchi, K, Kobashi, Y & Okimoto, N 1999, 'A double-blind comparative study of gatifloxacin and levofloxacin in pneumonia', Japanese Journal of Chemotherapy, vol. 47, no. 11, pp. 712-733.

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title = "A double-blind comparative study of gatifloxacin and levofloxacin in pneumonia",

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).",

keywords = "Gatifloxacin, Levofloxacin",

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

year = "1999",

language = "English",

volume = "47",

pages = "712--733",

journal = "Japanese Journal of Chemotherapy",

issn = "1340-7007",

publisher = "Japan Society of Chemotherapy",

number = "11",

}

TY - JOUR

T1 - A double-blind comparative study of gatifloxacin and levofloxacin in pneumonia

AU - Saito, A.

AU - Koike, T.

AU - Taneichi, K.

AU - Takeda, T.

AU - Takeuchi, K.

AU - Ohmichi, M.

AU - Sasaki, H.

AU - Inoue, H.

AU - Sato, M.

AU - Ohura, M.

AU - Aoyama, Y.

AU - Yoshida, M.

AU - Takeuchi, K.

AU - Miyamoto, N.

AU - Watanabe, A.

AU - Aso, N.

AU - Takahashi, H.

AU - Sano, Y.

AU - Arai, Y.

AU - Nakata, K.

AU - Nakatani, T.

AU - Goto, H.

AU - Kobayashi, H.

AU - Miura, H.

AU - Shishido, H.

AU - Sato, K.

AU - Matsumoto, F.

AU - Sakurai, I.

AU - Ohkubo, T.

AU - Ikeda, H.

AU - Nishikawa, M.

AU - Matsumura, M.

AU - Sato, M.

AU - Takagi, S.

AU - Tsubakihara, M.

AU - Takii, T.

AU - Numata, H.

AU - Aoki, N.

AU - Sekine, O.

AU - Suzuki, Y.

AU - Matsuda, M.

AU - Wada, K.

AU - Fuse, K.

AU - Iwata, F.

AU - Hoshino, S.

AU - Iwashima, A.

AU - Sato, A.

AU - Chida, K.

AU - Yagi, K.

AU - Sano, T.

AU - Suganuma, H.

AU - Tamura, R.

AU - Inui, N.

AU - Iwata, M.

AU - Nakamura, Y.

AU - Oda, S.

AU - Yanase, K.

AU - Kubo, N.

AU - Ueno, K.

AU - Shimokata, K.

AU - Yamamoto, M.

AU - Ando, M.

AU - Totani, Y.

AU - Sakai, S.

AU - Murate, T.

AU - Yamori, S.

AU - Iinuma, Y.

AU - Takagi, N.

AU - Iwata, M.

AU - Sugino, Y.

AU - Takagi, K.

AU - Tano, M.

AU - Iwata, M.

AU - Nagata, A.

AU - Ogawa, M.

AU - Noda, Y.

AU - Gonda, H.

AU - Ohishi, N.

AU - Kuze, F.

AU - Ikeda, N.

AU - Kurasawa, T.

AU - Nakatani, K.

AU - Ikeda, T.

AU - Bando, K.

AU - Ishikawa, N.

AU - Taniguchi, M.

AU - Mochizuki, Y.

AU - Kawamura, T.

AU - Miki, F.

AU - Narita, N.

AU - Mikasa, K.

AU - Sasaki, T.

AU - Matsumoto, Y.

AU - Soejima, R.

AU - Matsushima, T.

AU - Niki, Y.

AU - Hashiguchi, K.

AU - Kobashi, Y.

AU - Okimoto, N.

PY - 1999

Y1 - 1999

N2 - 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).

AB - 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).

KW - Gatifloxacin

KW - Levofloxacin

UR - http://www.scopus.com/inward/record.url?scp=0033405103&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033405103&partnerID=8YFLogxK

M3 - Article

AN - SCOPUS:0033405103

SN - 1340-7007

VL - 47

SP - 712

EP - 733

JO - Japanese Journal of Chemotherapy

JF - Japanese Journal of Chemotherapy

IS - 11

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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