Tuberc Respir Dis > Volume 55(1); 2003 > Article
Tuberculosis and Respiratory Diseases 2003;55(1):69-87.
DOI: https://doi.org/10.4046/trd.2003.55.1.69    Published online July 1, 2003.
A Randomized, Double-Blind Study to Assess the Efficacy and Safety of Oral LB20304 (Gemifloxacin) at Doses of 160mg or 320mg (Equivalent to 200mg or 400mg of the Mesylate Salt) Once Daily for 7 Days for the Treatment of Acute Exacerbations of Chronic Bron
Young Whan Kim, Young Soo Shim, Won Dong Kim, Tae Sun Shim, Hong Mo Kang, Byoung Whui Choi, Jae Yeol Kim, O Jung Kwon, Hojoong Kim, Ju Ock Kim, Ki Suck Jung, In Gyou Hyeon, Eun Kyung Mo, Seung Joon Lee, Gui Hyun Nam, Kye Young Lee, Jae Seuk Park
1Department of Internal Medicine, Seoul National University College of Medicine, Korea. ywkim@snu.ac.kr
2Department of Internal Medicine, University of Ulsan College of Medicine, Korea.
3Department of Internal Medicine, Kyung Hee University School of Medicine, Korea.
4Department of Internal Medicine, ChungAng University College of Medicine, Korea.
5Department of Internal Medicine, Sungkyunkwan University School of Medicine, Korea.
6Department of Internal Medicine, Chungnam National University College of Medicine, Korea.
7Department of Internal Medicine, Hallym University College of Medicine, Korea.
8Department of Internal Medicine, Gachon Medical School, Korea.
9Department of Internal Medicine, Dankook University College of Medicine, Korea.
Abstract
BACKGROUND
LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. METHODS: This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. RESULTS: The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(< or = 0.03 ug/mL) than those for other quinolones, beta-lactams and acrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. CONCLUSION: The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.
Key Words: Gemifloxacin, Fluoroquinolone, Acute exacerbations of chronic bronchitis


ABOUT
ARTICLE & TOPICS
Article category

Browse all articles >

Topics

Browse all articles >

BROWSE ARTICLES
FOR CONTRIBUTORS
Editorial Office
101-605, 58, Banpo-daero, Seocho-gu (Seocho-dong, Seocho Art-Xi), Seoul 06652, Korea
Tel: +82-2-575-3825, +82-2-576-5347    Fax: +82-2-572-6683    E-mail: katrdsubmit@lungkorea.org                

Copyright © 2022 by The Korean Academy of Tuberculosis and Respiratory Diseases. All rights reserved.

Developed in M2PI

Close layer
prev next