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ORIGINAL RESEARCH

Efficacy of amoxycillin versus amoxycillin/clavulanate in acute exacerbations of chronic pulmonary obstructive disease in primary care
Carl Llor 1 Silvia Hernández 1 Anna Ribas 2 Carmen Álvarez 3 Josep Maria Cots 4 Carolina Bayona 5 Isabel González 6 Marc Miravitlles 7 BRAMOX Study Group
Primary Care Centre Jaume I, Tarragona, Spain; 2 Primary Care Centre Santa Eugènia deBerga, Spain; 3 Primary Care Centre Manlleu, Spain; 4 Primary Care Centre La Marina, Barcelona, Spain; 5 Primary Care Centre Valls, Spain; 6 Primary Care Centre Maragall, Barcelona, Spain; 7 Pneumology Department. Institut Clínic del Tòrax (IDIBAPS), Hospital Clínic, Barcelona, CIBER de Enfermedades Respiratorias (CIBERES), Spain
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Background: Amoxycillin/clavulanate is considered first-linetreatment for ambulatory exacerbations of COPD. However, narrow-spectrum antibiotics may be as useful for mild to moderate patients. Objective: To compare the clinical efficacy of amoxycillin versus amoxicyllin/clavulanate in exacerbations of COPD in primary care. Methods: A randomized, double-blind, noninferiority clinical trial was carried out in eight primary care centers in Catalonia, Spain.Spirometrically-diagnosed patients older than 40 years with COPD, without criteria of hospitalization and Anthonisen’s types I or II exacerbations were included. The main outcome was clinical cure at the end of treatment (EOT) visit on day 10. Results: A total of 137 patients were enrolled in the study (68 assigned to amoxycillin and 69 to amoxycillin/clavulanate). The mean forced expiratory flow in onesecond was 61.6% and the mean age was 71.4 years. At EOT, 92.8% of patients in the amoxycillin/clavulanate and 90.9% in the amoxycillin group were considered clinically cured, a statistically non-significant difference. Adverse effects were observed in 11 subjects, 3 in the amoxycillin group and 8 in the amoxycillin/clavulanate group, 2 of whom required a change in treatment. Conclusions:Amoxycillin was at least as effective clinically and as safe as amoxycilin/ clavulanate in the treatment of acute exacerbations of COPD in mild to moderate patients in primary care. Keywords: exacerbation, chronic obstructive pulmonary disease, randomised controlled trial, amoxycillin, primary care, amoxycillin/clavulanate

Introduction
Chronic obstructive pulmonary disease (COPD) constitutes one of theprincipal demands of medical attention in primary care. According to local studies, it is estimated that up to 8%–10% of the population over 40 years of age may be affected by COPD and, in men over 65 years of age, this figure may rise to 20%.1 Exacerbations are acute episodes of an increase in respiratory symptoms that characterize the course of COPD and result in impaired quality of life,2,3particularly in moderate patients in primary care.4 Furthermore, they accelerate the decline in lung function,5 increase health care utilization6 and constitute the main cause of death of patients with COPD.7 Although the etiology of COPD exacerbations is not completely established, there is strong evidence that potentially pathogenic microorganisms (PPMs) are isolated in more than half of COPDpatients during exacerbations.8 Another 30%–40% of the exacerbations of COPD have recently been shown to be attributable to viruses9,10 alone or in combination with bacteria.11 The PPMs most commonly isolated during exacerbations are aerobic bacteria, with Haemophilus influenzae being the most frequent, followed by Streptococcus pneumoniae in second place and Moraxella catarrhalis, Chlamydophilapneumoniae, Mycoplasma pneumoniae, and Pseudomonas 45

Correspondence: Carl Llor c. Foixarda, 95. 43008 Tarragona, Spain Tel +34 6 7108 5857 Email carles.llor@urv.cat

International Journal of COPD 2009:4 45–53 © 2009 Llor et al, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited....