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Treatment with azithromycin significantly reduces the risk of pulmonary exacerbations and is badociated with improved body weight. On the other hand, its use has no effect on microbiological results in a pediatric population with cystic fibrosis (CF) and Pseudomonas aeruginosa infection. These are the findings of a recent study published in the American Journal of Respiratory and Critical Care Medicine that corroborates earlier observations on the effectiveness of azithromycin in improving lung function.
Treatment with azithromycin significantly reduces the risk of pulmonary exacerbations and is badociated with improvement in body weight. Its use, however, has no effect on microbiological results in a pediatric population with cystic fibrosis (CF) and Pseudomonas aeruginosa infection
. These are the findings of a published study recently in the American Journal of Respiratory and Critical Care Medicine supporting previous observations on the effectiveness of azithromycin in improving lung function
These Results were obtained through the badysis of OPTIMIZE trial data (optimization of the treatment of early infection Pseudomonas Aeruginosa in Cystic Fibrosis) that it was proposed to check if the Addition of azithromycin to an inhaled solution of tobramycin (TIS) (traditional antimicrobial therapy against Pseudomonas) could reduce the risk of pulmonary exacerbation and inflammation and, at the same time, delayoccurrence of recurrence of P. aeruginosa infection in patients with cystic fibrosis.
OPTIMIZATION e a randomized, multicenter, double-blind, placebo-controlled 18-month placebo, which had recruited a pediatric population of people aged 6 months to 18 years, with cystic fibrosis and an initial infection with P Aeruginosa,
The population recruited to the study was randomized to treatment. with azithromycin 3 times a week, in addition to the standard anti-Pseudomonas antibiotic (TIS).
The primary endpoint of the study was the delay in pulmonary exacerbation requiring an antibiotic, while the secondary secondary endpoint was given by time to recurrence of P. aeruginosa infection [19659003] The trial, randomized to a 1: 1 schedule, randomized 221 patients to placebo (n = 111) or azithromycin (n = 110).
Compared to placebo, patients treated with azithromycin had a 44% reduced risk of pulmonary exacerbation (HR = 0.56, p = 0.04)
. Azitro Mycine experienced an average weight increase of 1.27 kg compared to the control group (p = 0.046)
With respect to safety, researchers did not notice the emergence of new undesirable effects compared to known events nor documented evidence of adverse clinical or microbiological interactions between azithromycin and TIS
It is certain that the use of azithromycin on the parameters microbiological predicted by the study protocol did not bring significant benefits.
they ignored some intrinsic limitations of their work: for example, the test was completed earlier than expected based on a predetermined interim efficacy badysis for the main endpoint; this may have limited the amount of information available on the secondary criteria.
The researchers also stated that they were about to conduct future badessments of inflammatory markers at the end of the open-label phase of the study. This may help to better understand the reasons for reducing the risk of pulmonary exacerbations observed with azithromycin
Although the study was unable to document a delay in the recurrence of lymphatic dysfunction. P. aeruginosa infection, the authors believe that the long-term safety observed in this study, as well as the increase in the time interval required for the development of a new episode of pulmonary exacerbation, suggest that azithromycin might be a therapeutic option for patients with pediatric CF and P. aeruginosa at the beginning
NC
Bibliography
Mayer- Hamblett N, Retsch-Bogart G, Kloster M, et al. Azithromycin for early infection with pseudomonas in cystic fibrosis: the Randomized Trial Optimize [published online June 11, 2018]. Am J Respir Crit Care Med. Doi: 10.1164 / rccm.201802-0215OC
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