Efficacy of Antibiotic Therapy for Acute Exacerbations of Mild to Moderate COPD.
Am J Respir Crit Care Med. 2012 Aug 23;
Authors: Llor C, Moragas A, Hernández S, Bayona C, Miravitlles M
RATIONALE: Antimicrobial therapy remains a controversial issue in non-severe exacerbations of chronic obstructive pulmonary disease (COPD). OBJECTIVE: To evaluate the efficacy of antibiotic therapy in moderate exacerbations of mild-to-moderate COPD. METHODS: Multicenter, parallel, double-blind placebo-controlled, randomized clinical trial. Patients aged 40 or older, smokers or ex-smokers of ten packs-year or more, with spirometrically-confirmed mild-to-moderate COPD (forced expiratory volume in one second (FEV1)>50% predicted and FEV1/forced vital capacity ratio<0.7) and diagnosed with an exacerbation were enrolled in the study. The patients were randomized to receive either amoxicillin/clavulanate 500/125 mg t.i.d. or placebo t.i.d. for 8 days. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was clinical cure at end of therapy visit (EOT) at days 9-11. A total of 310 subjects fulfilled all the criteria for efficacy analysis. A total of 117 patients with amoxicillin/clavulanate (74.1%) and 91 with placebo (59.9%) were considered cured at EOT (difference = 14.2%; 95% confidence interval, 3.7 to 24.3%). The median time to the next exacerbation was significantly longer in patients receiving antibiotic compared to placebo (233 days [interquartile range, 110 to 365], compared to 160 days [interquartile range, 66 to 365] (P < 0.05). The best C-reactive protein serum cut-off for predicting clinical failure with placebo was 40 mg/l, with an area under the curve of 0.732 (95% confidence interval, 0.614 to 0.851). CONCLUSION: Treatment of ambulatory exacerbations of mild-to-moderate COPD with amoxicillin/clavulanate is more effective and significantly prolongs the time to the next exacerbation compared with placebo. Clinical trial registered with www.clinical.gov (NCT00495586).
PMID: 22923662 [PubMed - as supplied by publisher]