Highlights from

European Respiratory Society

Congress 2018

Paris 15-19 September 2018

Macrolide antibiotics and trial with azithromycin

No widespread use of macrolide antibiotics

Despite inhalation therapy, 20-50% of patients experience ≥1 exacerbation per year. Acute exacerbations of COPD (AECOPD) are associated with acute worsening of symptoms necessitating medical intervention. 20-25% of exacerbations require hospitalisation, which has a bad prognosis: 6% in-hospital mortality, 12% mortality within 3 months, and 35% risk of readmission. Macrolide antibiotics possess both anti-microbial and anti-inflammatory properties. The role of azithromycin for the prevention of COPD exacerbations was established in 2011 by the publication of a multicentre RCT, showing a 30% reduction of acute exacerbations during a chronic treatment with azithromycin. However, there has not been a widespread use of azithromycin. “That was mainly because of major safety concerns, being cardiac safety (QTc prolongation) and bacterial resistance”, explained Prof. Wim Janssens (University Hospital Leuven, Belgium).

Belgian trial with azithromycin

BACE was a Belgian RCT with azithromycin for COPD exacerbations requiring hospitalisation [27]. The hypothesis of the researchers was that the use of azithromycin in the acute setting would be a major step forward to a targeted clinical use. Some potential advantages might be the reduction of time course and dose of treatment; restriction of treatment to the subgroup with the highest need and at the highest risk; and even being able to disrupt the vicious cycle of admission, AECOPD, and readmission.

In the BACE trial, patients with an AECOPD were screened for eligibility within 24 hours and randomly received azithromycin or placebo on top of a standardised therapy. Azithromycin was continued for 90 days. The time-to-treatment failure at day 90 (primary endpoint) was not significantly different (HR 0.73; P=0.0526). Prof. Janssens concluded that azithromycin, initiated in the acute setting of a hospitalised patient with a severe AECOPD and continued for 3 months at low dose, seems to be safe. It is potentially an effective intervention to reduce treatment failure in the highest risk period [27]. The clinically important reduction of step-up in hospital care, i.e. from ward to intensive care unit or readmission after discharge, with significant reduction of total hospital days and days on intensive care, provides an important health-economic potential. Most of the benefits disappear over time if treatment is discontinued after 90 days, opposing against intermittent treatment regimens.

  1. Janssens W, et al. Late Breaking Abstract OA1654, ERS 2018.

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