Efficacy of Amoxycillin Versus amoxycillin/clavulanate in Acute Exacerbations of Chronic Pulmonary Obstructive Disease in Primary Care

Int J Chron Obstruct Pulmon Dis. 2009;4:45-53. Epub 2009 Apr 15.

Abstract

Background: Amoxycillin/clavulanate is considered first-line treatment 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 one second 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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Amoxicillin / adverse effects
  • Amoxicillin / therapeutic use*
  • Amoxicillin-Potassium Clavulanate Combination / adverse effects
  • Amoxicillin-Potassium Clavulanate Combination / therapeutic use*
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Forced Expiratory Volume
  • Humans
  • Lung / drug effects*
  • Lung / microbiology
  • Lung / physiopathology
  • Male
  • Middle Aged
  • Primary Health Care*
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / microbiology
  • Pulmonary Disease, Chronic Obstructive / physiopathology
  • Recovery of Function
  • Spain
  • Spirometry
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Amoxicillin-Potassium Clavulanate Combination
  • Amoxicillin