New results from a large clinical trial show that routine daily prophylactic antibiotic therapy can reduce the occurrence of acute exacerbations of COPD. Acute exacerbations in COPD are sudden onsets of severe cough, wheezing, and labored breathing. These exacerbations are often induced by infection. The clinical trial included 1,142 patients with moderate to severe COPD. All participants had a history of exacerbations in the previous year and /or needed oxygen therapy. Half of the group took Azithromycin 250mg daily for one year, in addition to their other COPD related medications. The group of patients who took the daily antibiotic averaged 1.48 acute exacerbations annually, compared to 1.83 exacerbations for the group who did not take the daily antibiotic. The patients who took the Azithromycin also scored their own breathing ability and overall well-being more favorably than the control group. There were findings of some azithromycin-resistant bacteria in some patients, however, no one developed a clinically evident infection. Side effects to azithromycin were reported to be minimal over the one year period.
Until these results were released, the perceived benefit of routine daily prophylactic antibiotic therapy has been quite controversial. Many experts have recommended against the use of prophylactic antibiotics for COPD citing a lack of clinical evidence for any benefits and the risk of increasing antibiotic resistance. Antibiotic therapy has been advocated only for treatment of active infections in COPD patients.
This previous lack of strong evidence is the reason why current Global Initiative for Chronic Obstructive Lung Disease guidelines [GOLD], discourage routine prophylactic antibiotic therapy in COPD stating that “prophylactic, continuous use of antibiotics has been shown to have no effect on the frequency of exacerbations in COPD” and that “there is no current evidence that the use of antibiotics, other than for treating infectious exacerbations of COPD and other bacterial infections, is helpful”. The new evidence suggests a beneficial effect of routine prophylactic antibiotic therapy with daily azithromycin in COPD patients. COPD treatment guidelines, such as those of GOLD, may be modified in the near future to reflect this.
The average wholesale price (AWP) for a month of prophylactic therapy with Azithromycin 250mg daily is approximately $185. This should be viewed within the context of the additional cost of treating a COPD acute exacerbation. The implication for hospice patients with severe COPD is that we may see more prophylactic antibiotic therapy employed to prevent or reduce acute exacerbations, with the goal of enhancing comfort care. There may also be a cost-benefit to prophylactic antibiotic therapy if actual costs related to the management of potential acute exacerbations (clinician time, care-giver time, increased medication) outweigh the cost of the antibiotic.
This study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institute of Health (NIH) and appears in the August 25th issue of the New England Journal of Medicine.
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