Amoxicillin/Clavulanate improves exacerbations in mild-to-moderate COPD

by Bruce Sylvester – FDA Highlights – According to a study published online on September 7, 2012 in the American Journal of Respiratory and Critical Care Medicine, treatment with amoxicillin/clavulanate improves moderate exacerbations in patients with mild-to-moderate chronic obstructive pulmonary disease (COPD).  It also appears to significantly prolong the time between exacerbations.
“The existing evidence for antibiotic therapy in non-severe exacerbations of COPD is weak,” said investigator and lead author  Carl Llor, MD, University Rovira i Virgili, Tarragona, Spain. “The results of our multicentre, randomised, double-blind, placebo-controlled trial show that antibiotic treatment is more effective than placebo in these patients, with an absolute difference in cure rates of 14.2%, and that the median time to next exacerbation is prolonged with antibiotic treatment, compared with placebo, from 160 to 233 days.”

Investigators enrolled 310 subjects in the study. They were randomized to receive either amoxicillin/clavulanate (500/125 mg) or placebo, 3 times daily for 8 days. Subjects were at least 40 years-old and had a spirometrically-confirmed diagnosis of mild-to-moderate COPD.

The primary endpoint was clinical cure by the end of the study.

A total of 117 patients in the amoxicillin/clavulanate group (74.1%) and 91 in the placebo group (59.9%) achieved a cure. And median time to next exacerbation was significantly longer in the amoxicillin/clavulanate group compared to placebo.

The antibiotic-treated group achieved clinical success, (cure or improvement), at a 90.5%  rate, compared with 80.9% in the placebo group.

The authors noted that capillary C-reactive protein (CRP) at a cut-off of 40 mg/l was a  predictor of clinical outcome, that patients with CRP levels <40 mg/l were significantly more likely to achieve a cure without antibiotics.

“We have shown that antibiotic treatment is superior to placebo in improving exacerbations in mild-to-moderate COPD,” Dr. Llor added. “Many of these patients are treated in primary care settings, and our study supports the use of antibiotics to treat mild to moderate airway obstruction, mainly in patients with elevated CRP levels.