Efficacy of amoxycillin versus amoxycillin/clavulanate in acute exacerbations of chronic pulmonary obstructive disease in primary care

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.

Keywords:

• exacerbation
• chronic obstructive pulmonary disease
• randomised controlled trial
• amoxycillin
• primary care
• amoxycillin/clavulanate

Acknowledgments

The Catalan Society of Family Medicine provided funding to the Pharmacy Department of the Hospital Joan XXIII (Tarragona) for preparation of the double blind medication used in the trial. No funding was obtained from any pharmaceutical industry. The authors have no conflicts of interest to declare in relation to this manuscript.

We wish to acknowledge the contribution of the following investigators to this study. BRAMOX Study Group members: Xabier Ansa (Primary Care Centre Sant Pere i Sant Pau, Tarragona), Montse Bonamaison (Primary Care Centre Manlleu), Marta Cereceda (Primary Care Centre Manlleu), Joan Deniel (Primary Care Centre Manlleu), Jordi Espina (Primary Care Centre Manlleu), Jordi Espinàs (Primary Care Centre Santa Eugènia de Berga), Teresa Ezquerra (Primary Care Centre Manlleu), Josep M. Gifré (Primary Care Centre Santa Eugènia de Berga), Ferran Grifoll (Primary Care Centre Sant Pere i Sant Pau, Tarragona), M. Mar Pedrerol (Primary Care Centre Manlleu), Albert Planes (Primary Care Centre Santa Eugènia de Berga), Xavier Pujol (Primary Care Centre Manlleu), Montserrat Ribas (Primary Care Centre Manlleu), Anna Rodríguez (Primary Care Centre Santa Eugènia de Berga), Rosa M. Salla (Primary Care Centre Santa Eugènia de Berga), Jordi Valldosera (Primary Care Centre Sant Pere i Sant Pau, Tarragona), Meritxell Vilajoana (Primary Care Centre Santa Eugènia de Berga), and Maria Vilamú (Primary Care Centre Manlleu).