Comparison between azithromycin and amoxicillin in the treatment of infectious exacerbation of chronic obstructive pulmonary disease.
OBJECTIVE
To compare the efficacy, safety, and tolerability of azithromycin and amoxicillin in the treatment of patients with infectious exacerbation of chronic obstructive pulmonary disease.


METHODS
This study was conducted at six medical centers across Brazil and included 109 patients from 33 to 82 years of age. Of those, 102 were randomized to receive either azithromycin (500 mg/day for three days, n = 49) or amoxicillin (500 mg every eight hours for ten days, n = 53). The patients were evaluated at the study outset, on day ten, and at one month. Based on the clinical evaluation of the signs and symptoms present on day ten and at one month, the outcomes were classified as cure, improvement, or treatment failure. The microbiological evaluation was made through the culture of sputum samples that were considered appropriate samples only after leukocyte counts and Gram staining. Secondary efficacy evaluations were made in order to analyze symptoms (cough, dyspnea, and expectoration) and pulmonary function.


RESULTS
There were no differences between the groups treated with azithromycin or amoxicillin in terms of the percentages of cases in which the outcomes were classified as cure or improvement: 85% vs. 78% (p = 0.368) on day ten; and 83% vs. 78% (p = 0.571) at one month. Similarly, there were no significant differences between the two groups in the secondary efficacy variables or the incidence of adverse effects.


CONCLUSIONS
Azithromycin and amoxicillin present similar efficacy and tolerability in the treatment of acute exacerbation of chronic obstructive pulmonary disease.
Andre-Alves
Mara Rúbia
MR
Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil. mara@orion.ufrs.br
Jardim
José Roberto
JR
Frare e Silva
Rodney
R
Fiss
Elie
E
Freire
Denison Noronha
DN
Teixeira
Paulo José Zimermann
PJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D000658:Amoxicillin / Q000627:therapeutic use*; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017963:Azithromycin / Q000627:therapeutic use*; D005260:Female; D006090:Gram-Negative Bacteria / Q000302:isolation & purification; D006095:Gram-Positive Cocci / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000658:Amoxicillin; D017963:Azithromycin