gemifloxacin and Bronchitis--Chronic

Gemifloxacin is a fluoroquinolone antibiotic with broad spectrum of antibacterial activity. The aim of the study was to evaluate the comparative effectiveness and safety of gemifloxacin for the treatment of patients with community-acquired pneumonia (CAP) or acute exacerbation of chronic bronchitis (AECB).. We performed a meta-analysis of randomized controlled trials (RCTs) comparing gemifloxacin with other approved antibiotics. The PubMed, EMBASE, Chinese Biomedical Literature Database and the Cochrane Central Register of Controlled Trials were searched, with no language restrictions.. Ten RCTs, comparing gemifloxacin with other quinolones (in 5 RCTs) and β-lactams and/or macrolides (in 5 RCTs), involving 3940 patients, were included in this meta-analysis. Overall, the treatment success was higher for gemifloxacin when compared with other antibiotics (odds ratio 1.39, 95% confidence interval 1.15 - 1.68 in intention-to-treat patients, and 1.33, 1.02 - 1.73 in clinically evaluable patients). There was no significant difference between the compared antibiotics regarding microbiological success (1.19, 0.84 - 1.68) or all-cause mortality (0.82, 0.41 - 1.63). The total drug related adverse events were similar for gemifloxacin when compared with other quinolones (0.89, 0.56 - 1.41), while lower when compared with β-lactams and/or macrolides (0.71, 0.57 - 0.89). In subgroup analyses, administration of gemifloxacin was associated with fewer cases of diarrhoea and more rashes compared with other antibiotics (0.66, 0.48 - 0.91, and 2.36, 1.18 - 4.74, respectively).. The available evidence suggests that gemifloxacin 320 mg oral daily is equivalent or superior to other approved antibiotics in effectiveness and safety for CAP and AECB. The development of rash represents potential limitation of gemifloxacin.

Topics: Anti-Bacterial Agents; Bronchitis, Chronic; Community-Acquired Infections; Fluoroquinolones; Gemifloxacin; Humans; Naphthyridines; Pneumonia; Quinolones; Randomized Controlled Trials as Topic; Treatment Outcome

The newest generation of fluoroquinolones have proven efficacy against bacterial organisms associated with acute exacerbation of chronic bronchitis (AECB). Gemifloxacin, as one of the quinolones in this class, exhibits many of the pharmacokinetic and pharmacodynamic characteristics of the class with a few notable differences. Against Streptococccus pneumoniae it has a lower minimal inhibitory concentration (MIC) than the other respiratory fluoroquinolones and it has activity against both bacterial DNA gyrase and topoisomerase IV. The increased activity of gemifloxacin against both enzymes may be associated with decreased rates of resistance. Clinically, gemifloxacin has been shown to have positive effects on length of hospitalization and increased success at long-term follow-up in AECB patients. These associations were observed in noninferiority comparison studies. Although an advantage with the use of gemifloxacin in AECB is suggested, there are no comparison data is available to conclude that gemifloxacin is superior to the other respiratory fluoroquinolones. Gemifloxacin is generally well tolerated, but is associated with a characteristic rash and gastrointestinal upset as its most common observed side effects.

Topics: Animals; Anti-Bacterial Agents; Bronchitis, Chronic; Cost-Benefit Analysis; Disease Models, Animal; Drug Costs; Drug Resistance, Bacterial; Fluoroquinolones; Gemifloxacin; Humans; Microbial Sensitivity Tests; Naphthyridines; Treatment Outcome

The fluoroquinolone gemifloxacin has recently been approved for the treatment of acute bacterial exacerbations of chronic bronchitis and mild community acquired pneumonia, including that caused by multidrug-resistant Streptococcus pneumoniae. Owing to the increasing prevalence of multidrug-resistant S. pneumoniae, as well as resistance to other common pathogens of acute bacterial exacerbations of chronic bronchitis and community acquired pneumonia, it is important to have new, potent antimicrobial agents for the treatment of these infections. Gemifloxacin is the most potent antimicrobial agent in vitro for S. pneumoniae, and has excellent activity against the other key pathogens of acute bacterial exacerbations of chronic bronchitis and community acquired pneumonia, including the atypical microorganisms. The clinical trial outcomes of several studies that have evaluated gemifloxacin show a range of superior clinical or bacteriologic outcomes against several current antimicrobials, including levofloxacin, clarithromycin, trovafloxacin and ceftriaxone. The safety profile of gemifloxacin is similar to that of approved agents to treat acute bacterial exacerbations of chronic bronchitis and community acquired pneumonia, with a low discontinuation rate of 2.2%. A nonphototoxic rash (usually a mild, maculopapular rash) was observed in 2.8% of patients in clinical studies.

Topics: Acute Disease; Animals; Anti-Bacterial Agents; Bronchitis, Chronic; Community-Acquired Infections; Drug Resistance, Bacterial; Fluoroquinolones; Gemifloxacin; Humans; Naphthyridines; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Streptococcus pneumoniae; Treatment Outcome

In a randomized, open-label, controlled, multicentre study, the clinical and bacteriological efficacy, safety and tolerability of oral gemifloxacin (320 mg once daily, 5 days) was compared with sequential intravenous (i.v.) ceftriaxone (1 g once daily, maximum 3 days) followed by oral cefuroxime axetil (500 mg twice daily, maximum 7 days) in adult hospitalized patients with acute exacerbations of chronic bronchitis (AECB) (n = 274). The clinical success rates at follow-up (21-28 days post-therapy) in the clinical per-protocol population (the primary endpoint) were 86.8% (105/121) for gemifloxacin vs. 81.3% (91/112) for ceftriaxone/cefuroxime (treatment difference = 5.5,95% CI -3.9,14.9). The corresponding clinical results in the clinical intention-to-treat (ITT) population were 82.6% (114/138) vs. 72.1% (98/136), respectively (treatment difference = 10.5,95% CI 0.7, 20.4).Thus, gemifloxacin had significantly higher clinical success rates than ceftriaxone/cefuroxime. The median time to discharge was 9 days in the gemifloxacin group vs. 11 days in the ceftriaxone/cefuroxime group (P = 0.04, Wilcoxon test). At follow-up, 120/138 (87.0%) gemifloxacin-treated patients had been discharged from hospital, compared with 111/136 (81.6%) ceftriaxone/cefuroxime-treated patients in the clinical ITT population. Both treatments were generally well tolerated and there was no significant difference between the treatment groups in the incidence or type of adverse events reported. A 5-day course of oral gemifloxacin was shown by this study to be at least equivalent to sequential i.v. ceftriaxone/cefuroxime axetil (for up to 10 days) in patients with AECB who require hospital treatment.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Infective Agents; Bacterial Infections; Bronchitis, Chronic; Ceftriaxone; Cefuroxime; Drug Therapy, Combination; Female; Fluoroquinolones; Forced Expiratory Volume; Gemifloxacin; Hospitalization; Humans; Infusions, Intravenous; Length of Stay; Male; Middle Aged; Naphthyridines; Treatment Outcome

This randomised, double-blind, double-dummy, multinational study compared the efficacy and safety of gemifloxacin with trovafloxacin in the treatment of acute exacerbations of chronic bronchitis. There were 617 patients randomised: 303 to gemifloxacin and 314 to trovafloxacin. Clinical success rates at follow-up (clinical per-protocol population) were 91.5% for gemifloxacin and 87.6% for trovafloxacin. For the intent-to-treat population, the clinical efficacy of gemifloxacin was statistically significantly superior to that of trovafloxacin. In general, the in vitro activity of gemifloxacin against the major respiratory bacterial pathogens was superior to that of other antibiotics tested. Per-patient bacteriological success rates at follow-up (bacteriology per-protocol population) were 86.8% for gemifloxacin and 82.4% for trovafloxacin. Both agents were well tolerated. The clinical and bacteriological efficacy of a once-daily 5-day course of gemifloxacin is at least as good as that of a similar regimen of trovafloxacin in the treatment of acute exacerbations of chronic bronchitis.

Topics: Adult; Aged; Aged, 80 and over; Anti-Infective Agents; Bronchitis, Chronic; Chronic Disease; Double-Blind Method; Drug Administration Schedule; Female; Fluoroquinolones; Follow-Up Studies; Gemifloxacin; Humans; Lung; Male; Middle Aged; Naphthyridines; Time Factors; Treatment Outcome