Clinical Question

Does use of amoxicillin/clavulanate (Augmentin) improve outcomes in patients with exacerbations of mild to moderate chronic obstructive pulmonary disease (COPD)?

Bottom Line

Patients with exacerbations of mild to moderate COPD have a higher rate of cure when given amoxicillin/clavulanate compared with placebo. (Level of Evidence = 2b)

Reference

LlorCMoragasAHernándezSBayonaCMiravitllesMEfficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease. Am J Respir Crit Care Med.2012; 186( 8): 716– 723.

Study design: Randomized controlled trial (double-blinded)

Funding source: Foundation

Allocation: Concealed

Setting: Outpatient (primary care)

Synopsis

The 2010 update to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline on management of COPD limits the role of antibiotics in patients with infectious exacerbations; it recommends that patients have purulent sputum plus increased dyspnea or increased sputum volume before receiving antibiotics. However, the data on the role of antibiotics in patients with mild disease are limited. The researchers for this study randomly assigned patients with mild to moderate COPD with exacerbations (at least one of the following: increased dyspnea, increase in sputum volume, or purulent sputum) to receive amoxicillin/clavulanate (500/125 mg three times daily) or placebo. The treating physicians could prescribe corticosteroids in addition to the antibiotic (which happened in approximately 17 percent of patients in each group).

The treating physician evaluated each patient for clinical cure nine to 11 days after treatment. The authors used intention-to-treat to evaluate the outcomes. Approximately 75 percent of patients treated with antibiotics were cured, compared with 60 percent of those treated with placebo (number needed to treat = 8; 95% confidence interval, 5 to 27). Additionally, patients taking antibiotics had a longer time to the next exacerbation compared with patients taking placebo (233 versus 160 days). Two patients stopped taking the antibiotics because of gastrointestinal distress.