Long-term course of clarithromycin for the treatment of stage II COPD patients with frequent exacerbations

Abstract number: P848

Zykov K., Averianov A., Shmelev E., Tsoi A., Rvatcheva A., Brodskaya O., Chuchalin A.

It was shown that standard courses of antibiotic treatment of exacerbation of chronic obstructive pulmonary disease (COPD) with macrolides or b-lactams have clinical benefits and may also reduce the frequency of further exacerbations. But the data about the long-term courses of macrolide treatment are still controversial.

The aim of the study was evaluate the safety and efficacy of long-term course of clarithromycin in comparison with standard course of amoxicillin/clavulanate potassium for the treatment of stage II COPD patients with frequent exacerbations.

Methods: 51 patients (32 male and 19 female) with exacerbation of stage II COPD were enrolled in randomised parallel-group multicentre trial to compare the efficacy of course of clarithromycin (CLA)(Fromilid, KRKA, Slovenia)with standard course of amoxicillin/clavulanate potassium (AMC) tablets (Amoksiklav, Lek d.d., Slovenia). All patients (mean age 57.3±1.1 years, smoking history 34.1±1.6 pack/years, FEV1 50.2±1.8 of predicted) had frequent exacerbations (3 or more per year)of COPD. Chlamydophila pneumoniae IgG antibodies in diagnostic titers were found in 70.5% patients. After randomisation 25 patients of AMC group received 625 mg of AMC three times a day during 10 days. 26 patients of CLA group were treated with 500 mg of CLA twice daily during 10 days then 250 mg once daily during 50 days. The follow-up period was 12 months. The study was conducted according to the GCP rules, Helsinki Declaration and Russian laws.

Results: No one patient has dropped out of the study. In CLA group there were 6 mild and 2 moderate, in AMC group – 2 mild and 5 moderate adverse events that did not need to stop the treatment. Dyspnea (MRC scale), sputum volume and purulence significantly reduced in both groups after 12 months. FEV1 changes in both groups were unreliable. The number of exacerbations in CLA group reduced from 4.3±0.2 to 1.4±0.2, and in AMC group – from 4.5±0.3 to 2.4±0.3 per year. Exacerbation-free interval was longer in CLA group 258.4±17.0 days than in AMC group 192.8±24.8 (p<0.03).

Conclusion: long-term courses of clarithromycin for the COPD treatment are safe with few mild adverse events. Changes of dyspnea, spirometry parameters, sputum volume and purulence in CLA-treated and AMC-treated patients were equivalent. Long-term clarithromycin treatment of stage II COPD patients with frequent exacerbations was associated with longer exacerbation-free interval compared to standard AMC treatment.

Session Details

Date: 19/04/2008
Time: 00:00-00:00
Session name: 18th European Congress of Clinical Microbiology and Infectious Diseases
Location: Barcelona, Spain
Presentation type:
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