Efficacy and tolerability of gatifloxacin in community treatment of acute exacerbations of chronic bronchitis

Antonio R Anzueto, Mark Gotfried, Matthew A. Wikler, Rene Russo, Susan C. Nicholson

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background: Recognizing acute exacerbations of chronic bronchitis (AECB) and selecting appropriate antibiotic treatment for patients who would benefit most is a challenge for community-based physicians. Objective: The Tequin Clinical Experience Study, an open-label, noncomparative, post-marketing trial, assessed the efficacy and tolerability of gatifloxacin, an 8-methoxy fluoroquinolone, in the treatment of AECB in the community-practice setting. Methods: Consecutive patients with respiratory tract infections in community-based settings were eligible for participation. Treated patients (N = 2512) included 1107 men (44.1%) and 1405 women (55.9%) aged ≥18 years with a clinical diagnosis of chronic bronchitis. All participants received oral gatifloxacin 400 mg once daily for 7 to 10 days. Clinical response was determined via telephone contact conducted by the investigator or study coordinator using case-report forms or during an office visit after the last dose. The investigator or coordinator collected expectorated or induced sputum specimens that were then smeared on a microscope slide, stored in a tube, and transported to a central reference laboratory for Gram-staining and culture. Of 1388 pretreatment sputum specimens submitted, pathogens were isolated from 424. Results: The most frequently detected pathogens were Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae. All H influenzae and 99% of S pneumoniae isolates tested were susceptible to gatifloxacin. Of the 2267 patients with a determinable clinical response, 2084 (91.9% [95% CI, 90.8%-93.0%]) were cured (all acute symptoms improved or returned to baseline level, no new symptoms present, no additional antibiotic required). The 95.8% cure rate in 166 patients with H influenzae included 100% of those with beta-lactamase-positive strains. Overall, 89.2% of 111 patients with M catarrhalis were cured; rates were similar regardless of beta-lactamase production. The clinical cure rate in 74 patients with S pneumoniae was 98.6% and was independent of the degree of penicillin resistance (minimum inhibitory concentration ≥2.0 μg/mL). All 6 patients infected with S pneumoniae fully resistant to penicillin were cured. Gatifloxacin was generally well tolerated, and the majority of adverse events were mild to moderate; only 11 drug-related adverse events in 10 patients (0.4%) were serious. Drug-related nausea (3.0%), dizziness (1.5%), diarrhea (1.2%), and vomiting (0.9%) were the most common adverse events. Conclusions: The high clinical cure rate and favorable tolerability support gatifloxacin as a rational choice for the treatment of AECB in patients such as those in this community-based study.

Original languageEnglish (US)
Pages (from-to)906-917
Number of pages12
JournalClinical Therapeutics
Volume24
Issue number6
DOIs
StatePublished - 2002

Fingerprint

Chronic Bronchitis
Therapeutics
Pneumonia
beta-Lactamases
Sputum
Human Influenza
Research Personnel
gatifloxacin
Anti-Bacterial Agents
Penicillin Resistance
Moraxella (Branhamella) catarrhalis
Office Visits
Fluoroquinolones
Haemophilus influenzae
Dizziness
Microbial Sensitivity Tests
Streptococcus pneumoniae
Marketing
Drug-Related Side Effects and Adverse Reactions
Telephone

Keywords

  • Acute exacerbations of chronic bronchitis
  • Fluoroquinolone
  • Gatifloxacin

ASJC Scopus subject areas

  • Pharmacology

Cite this

Efficacy and tolerability of gatifloxacin in community treatment of acute exacerbations of chronic bronchitis. / Anzueto, Antonio R; Gotfried, Mark; Wikler, Matthew A.; Russo, Rene; Nicholson, Susan C.

In: Clinical Therapeutics, Vol. 24, No. 6, 2002, p. 906-917.

Research output: Contribution to journalArticle

Anzueto, Antonio R ; Gotfried, Mark ; Wikler, Matthew A. ; Russo, Rene ; Nicholson, Susan C. / Efficacy and tolerability of gatifloxacin in community treatment of acute exacerbations of chronic bronchitis. In: Clinical Therapeutics. 2002 ; Vol. 24, No. 6. pp. 906-917.
@article{c52094b8d2a5493e915011f6b02ae8ba,
title = "Efficacy and tolerability of gatifloxacin in community treatment of acute exacerbations of chronic bronchitis",
abstract = "Background: Recognizing acute exacerbations of chronic bronchitis (AECB) and selecting appropriate antibiotic treatment for patients who would benefit most is a challenge for community-based physicians. Objective: The Tequin Clinical Experience Study, an open-label, noncomparative, post-marketing trial, assessed the efficacy and tolerability of gatifloxacin, an 8-methoxy fluoroquinolone, in the treatment of AECB in the community-practice setting. Methods: Consecutive patients with respiratory tract infections in community-based settings were eligible for participation. Treated patients (N = 2512) included 1107 men (44.1{\%}) and 1405 women (55.9{\%}) aged ≥18 years with a clinical diagnosis of chronic bronchitis. All participants received oral gatifloxacin 400 mg once daily for 7 to 10 days. Clinical response was determined via telephone contact conducted by the investigator or study coordinator using case-report forms or during an office visit after the last dose. The investigator or coordinator collected expectorated or induced sputum specimens that were then smeared on a microscope slide, stored in a tube, and transported to a central reference laboratory for Gram-staining and culture. Of 1388 pretreatment sputum specimens submitted, pathogens were isolated from 424. Results: The most frequently detected pathogens were Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae. All H influenzae and 99{\%} of S pneumoniae isolates tested were susceptible to gatifloxacin. Of the 2267 patients with a determinable clinical response, 2084 (91.9{\%} [95{\%} CI, 90.8{\%}-93.0{\%}]) were cured (all acute symptoms improved or returned to baseline level, no new symptoms present, no additional antibiotic required). The 95.8{\%} cure rate in 166 patients with H influenzae included 100{\%} of those with beta-lactamase-positive strains. Overall, 89.2{\%} of 111 patients with M catarrhalis were cured; rates were similar regardless of beta-lactamase production. The clinical cure rate in 74 patients with S pneumoniae was 98.6{\%} and was independent of the degree of penicillin resistance (minimum inhibitory concentration ≥2.0 μg/mL). All 6 patients infected with S pneumoniae fully resistant to penicillin were cured. Gatifloxacin was generally well tolerated, and the majority of adverse events were mild to moderate; only 11 drug-related adverse events in 10 patients (0.4{\%}) were serious. Drug-related nausea (3.0{\%}), dizziness (1.5{\%}), diarrhea (1.2{\%}), and vomiting (0.9{\%}) were the most common adverse events. Conclusions: The high clinical cure rate and favorable tolerability support gatifloxacin as a rational choice for the treatment of AECB in patients such as those in this community-based study.",
keywords = "Acute exacerbations of chronic bronchitis, Fluoroquinolone, Gatifloxacin",
author = "Anzueto, {Antonio R} and Mark Gotfried and Wikler, {Matthew A.} and Rene Russo and Nicholson, {Susan C.}",
year = "2002",
doi = "10.1016/S0149-2918(02)80006-6",
language = "English (US)",
volume = "24",
pages = "906--917",
journal = "Clinical Therapeutics",
issn = "0149-2918",
publisher = "Excerpta Medica",
number = "6",

}

TY - JOUR

T1 - Efficacy and tolerability of gatifloxacin in community treatment of acute exacerbations of chronic bronchitis

AU - Anzueto, Antonio R

AU - Gotfried, Mark

AU - Wikler, Matthew A.

AU - Russo, Rene

AU - Nicholson, Susan C.

PY - 2002

Y1 - 2002

N2 - Background: Recognizing acute exacerbations of chronic bronchitis (AECB) and selecting appropriate antibiotic treatment for patients who would benefit most is a challenge for community-based physicians. Objective: The Tequin Clinical Experience Study, an open-label, noncomparative, post-marketing trial, assessed the efficacy and tolerability of gatifloxacin, an 8-methoxy fluoroquinolone, in the treatment of AECB in the community-practice setting. Methods: Consecutive patients with respiratory tract infections in community-based settings were eligible for participation. Treated patients (N = 2512) included 1107 men (44.1%) and 1405 women (55.9%) aged ≥18 years with a clinical diagnosis of chronic bronchitis. All participants received oral gatifloxacin 400 mg once daily for 7 to 10 days. Clinical response was determined via telephone contact conducted by the investigator or study coordinator using case-report forms or during an office visit after the last dose. The investigator or coordinator collected expectorated or induced sputum specimens that were then smeared on a microscope slide, stored in a tube, and transported to a central reference laboratory for Gram-staining and culture. Of 1388 pretreatment sputum specimens submitted, pathogens were isolated from 424. Results: The most frequently detected pathogens were Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae. All H influenzae and 99% of S pneumoniae isolates tested were susceptible to gatifloxacin. Of the 2267 patients with a determinable clinical response, 2084 (91.9% [95% CI, 90.8%-93.0%]) were cured (all acute symptoms improved or returned to baseline level, no new symptoms present, no additional antibiotic required). The 95.8% cure rate in 166 patients with H influenzae included 100% of those with beta-lactamase-positive strains. Overall, 89.2% of 111 patients with M catarrhalis were cured; rates were similar regardless of beta-lactamase production. The clinical cure rate in 74 patients with S pneumoniae was 98.6% and was independent of the degree of penicillin resistance (minimum inhibitory concentration ≥2.0 μg/mL). All 6 patients infected with S pneumoniae fully resistant to penicillin were cured. Gatifloxacin was generally well tolerated, and the majority of adverse events were mild to moderate; only 11 drug-related adverse events in 10 patients (0.4%) were serious. Drug-related nausea (3.0%), dizziness (1.5%), diarrhea (1.2%), and vomiting (0.9%) were the most common adverse events. Conclusions: The high clinical cure rate and favorable tolerability support gatifloxacin as a rational choice for the treatment of AECB in patients such as those in this community-based study.

AB - Background: Recognizing acute exacerbations of chronic bronchitis (AECB) and selecting appropriate antibiotic treatment for patients who would benefit most is a challenge for community-based physicians. Objective: The Tequin Clinical Experience Study, an open-label, noncomparative, post-marketing trial, assessed the efficacy and tolerability of gatifloxacin, an 8-methoxy fluoroquinolone, in the treatment of AECB in the community-practice setting. Methods: Consecutive patients with respiratory tract infections in community-based settings were eligible for participation. Treated patients (N = 2512) included 1107 men (44.1%) and 1405 women (55.9%) aged ≥18 years with a clinical diagnosis of chronic bronchitis. All participants received oral gatifloxacin 400 mg once daily for 7 to 10 days. Clinical response was determined via telephone contact conducted by the investigator or study coordinator using case-report forms or during an office visit after the last dose. The investigator or coordinator collected expectorated or induced sputum specimens that were then smeared on a microscope slide, stored in a tube, and transported to a central reference laboratory for Gram-staining and culture. Of 1388 pretreatment sputum specimens submitted, pathogens were isolated from 424. Results: The most frequently detected pathogens were Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae. All H influenzae and 99% of S pneumoniae isolates tested were susceptible to gatifloxacin. Of the 2267 patients with a determinable clinical response, 2084 (91.9% [95% CI, 90.8%-93.0%]) were cured (all acute symptoms improved or returned to baseline level, no new symptoms present, no additional antibiotic required). The 95.8% cure rate in 166 patients with H influenzae included 100% of those with beta-lactamase-positive strains. Overall, 89.2% of 111 patients with M catarrhalis were cured; rates were similar regardless of beta-lactamase production. The clinical cure rate in 74 patients with S pneumoniae was 98.6% and was independent of the degree of penicillin resistance (minimum inhibitory concentration ≥2.0 μg/mL). All 6 patients infected with S pneumoniae fully resistant to penicillin were cured. Gatifloxacin was generally well tolerated, and the majority of adverse events were mild to moderate; only 11 drug-related adverse events in 10 patients (0.4%) were serious. Drug-related nausea (3.0%), dizziness (1.5%), diarrhea (1.2%), and vomiting (0.9%) were the most common adverse events. Conclusions: The high clinical cure rate and favorable tolerability support gatifloxacin as a rational choice for the treatment of AECB in patients such as those in this community-based study.

KW - Acute exacerbations of chronic bronchitis

KW - Fluoroquinolone

KW - Gatifloxacin

UR - http://www.scopus.com/inward/record.url?scp=0035986659&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0035986659&partnerID=8YFLogxK

U2 - 10.1016/S0149-2918(02)80006-6

DO - 10.1016/S0149-2918(02)80006-6

M3 - Article

C2 - 12117081

AN - SCOPUS:0035986659

VL - 24

SP - 906

EP - 917

JO - Clinical Therapeutics

JF - Clinical Therapeutics

SN - 0149-2918

IS - 6

ER -