Levofloxacin 750 mg QD for five days versus amoxicillin/clavulanate 875 mg/125 mg BID for ten days for treatment of acute bacterial exacerbation of chronic bronchitis: A post hoc analysis of data from severely ill patients

This post hoc analysis of data from a previous randomized, blinded, multicenter, parallel, noninferiority study assessed the bacterial etiology, symptom resolution, and tolerability of severe acute bacterial exacerbation of chronic bronchitis (ABECB) patients treated with either levofloxacin 750 mg...

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Bibliographic Details
Published in:	Clinical therapeutics Vol. 28; no. 8; pp. 1175 - 1180
Main Authors:	Grossman, Ronald F., Ambrusz, Mary E., Fisher, Alan C., Khashab, Mohammed M., Kahn, James B.
Format:	Journal Article
Language:	English
Published:	Belle Mead, NJ Elsevier Inc 01-08-2006 Excerpta Medica Elsevier Limited
Subjects:	acute bacterial exacerbation of chronic bronchitis Aged Amoxicillin-Potassium Clavulanate Combination - administration & dosage amoxicillin/clavulanate Anti-Bacterial Agents - administration & dosage Bacterial Infections - drug therapy Biological and medical sciences Bronchitis - drug therapy Chronic Disease Chronic obstructive pulmonary disease, asthma Drug Administration Schedule Female Humans Levofloxacin Male Medical sciences Ofloxacin - administration & dosage Pharmacology. Drug treatments Pneumology short-course tolerability amoxicillin/clavulanate levofloxacin acute bacterial exacerbation of chronic bronchitis tolerability short-course Levofloxacin Clavulanic acid Toxicity β-Lactamase Penicillin derivatives Fluoroquinolone derivatives Bronchus disease Bacteria Bronchitis Quinolone derivatives Human Data analysis Respiratory disease Enzyme β-Lactams Acute Enzyme inhibitor Exacerbation Antibiotic Chronic Treatment Amoxicillin Hydrolases Antibacterial agent Comparative study
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Summary:	This post hoc analysis of data from a previous randomized, blinded, multicenter, parallel, noninferiority study assessed the bacterial etiology, symptom resolution, and tolerability of severe acute bacterial exacerbation of chronic bronchitis (ABECB) patients treated with either levofloxacin 750 mg QD for 5 days or amoxicillin/clavulanate 875 mg/125 mg BID for 10 days. Severe ABECB was defined as ABECB and forced expiratory volume in 1 second (FEV1) <50% of the predicted value, or (FEV1) of 50% to 65% of the predicted value plus comorbidities, or ≥4 exacerbations per year. A total of 369 patients were included in the intent-totreat (ITT) population (187 treated with levofloxacin and 182 treated with amoxicillin/clavulanate), and 175 patients were microbiologically assessable (MA) (86 treated with levofloxacin and 89 treated with amoxicillin/clavulanate). In the ITT population, the mean age was 58.7 years, 49.1 % were male, and 48.2% were current smokers. At the on-treatment visit, a significantly higher proportion of MA patients in the levofloxacin group resolved purulent sputum production (57.5% vs 35.6%; P < 0.006), sputum production (65.4% vs 45.3%; P < 0.013), and cough (60.0% vs 44.0%; P < 0.045), compared with the amoxicillin/clavulanate group. However, no significant between-group differences were observed at posttreatment. A total of 341 pathogens were isolated, of which 143 (41.9%) were traditional ABECB flora, 181 (53.1%) were other gram-negative organisms, and 17 (5.0%) were gram-positive organisms. Overall susceptibility of the pathogens was 97.1% for levofloxacin and 90.6% for amoxicillin/clavulanate (P < 0.001). The prevalence of treatment-emergent adverse events was 42.1 % in patients who received levofloxacin and 48.6 % in those who received amoxicillin/clavulanate (95% CI,-4.0 to 17.0).
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ISSN:	0149-2918 1879-114X
DOI:	10.1016/j.clinthera.2006.08.013