Effect of Treatment for Chronic Obstructive Pulmonary Disease (COPD) on Hospitalization Rates, Emergency Department or Urgent Care Visits, and Unscheduled Office Visits. Druss BG, Marcus SC, Olfson M, Pincus HA. The complete protocol, including the statistical analysis plan, is available with the full text of this article at NEJM.org. When we began the study, we obtained both expectorated sputum samples and nasopharyngeal swabs because we knew that some patients would not be able to produce sputum. In a randomized trial of 1,142 patients with chronic obstructive pulmonary disease, more than one year of azithromycin treatment decreased the frequency of exacerbations [29]. COPD 2005;2:311-318. 25 Seven small studies that tested whether macrolides decrease the frequency of acute exacerbations of COPD reported conflicting results.26-32 Accordingly, we conducted a large, randomized trial to test the hypothesis that azithromycin decreases the frequency of acute exacerbations of COPD when added to the usual care of these patients. The study was approved by the institutional review board at each participating institution. DOI: 10.1056/NEJMoa1104623, Tap into groundbreaking research and clinically relevant insights. Thorax 2002;57:847-852[Erratum, Thorax 2008;63:753. No significant differences were observed in the frequency of serious adverse events or of adverse events leading to discontinuation of the study drug, but an audiogram-confirmed hearing decrement occurred in 142 of the participants receiving azithromycin (25%), as compared with 110 of those receiving placebo (20%) (P=0.04). Efficacy of salmeterol xinafoate in the treatment of COPD. Although azithromycin is an antibiotic, you will still need to take other antibiotics for any chest infections or flare-ups of COPD. Among subjects at increased risk for acute exacerbations of COPD who received azithromycin, at a dose of 250 mg once daily, for 1 year in addition to their usual care, the frequency of acute exacerbations was decreased. The authorized source of trusted medical research and education for the Chinese-language medical community. May 3, 2019─The antibiotic azithromycin may reduce treatment failure in patients hospitalized for an acute exacerbation of chronic obstructive pulmonary disease (COPD), according to a randomized, controlled trial published online in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine. Burge PS, Calverley PMA, Jones PW, Spencer S, Anderson JA, Maslen TK. Because most COPD patients who experience an acute exacerbation are already in treatment, researchers wanted to replicate that real-world scenario. Thorax 2005;60:925-931, 12. Valuable tools for building a rewarding career in health care. Eur Respir J 2002;19:217-224, 18. Conclusions: This post-hoc analysis of the BACE trial shows that azithromycin initiated at the onset of an infectious COPD exacerbation requiring hospitalization reduces the incidence rate of TF within 3 m by preventing hospital readmissions. ); the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston (G.R.W. The primary analysis was based on a log-rank test of the difference between the two treatment groups in the time to the first exacerbation, with no adjustments for baseline covariates. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Efron B, Tibshirani RJ. ), the University of Colorado Denver Health Sciences Center (R.K.A., B.M., C.S.P. In the study (NCT02135354), researchers investigated whether adding azithromycin to the standard treatment of hospitalized COPD patients with acute exacerbation (i.e., systemic corticosteroids and other antibiotics), would reduce the high percentage of treatment failure. Although this intervention could change microbial resistance patterns, the effect of this change is not known. The COPD Clinical Network designed this trial as a large-scale randomized control trial to test these early findings and demonstrated that azithromycin, when added to usual care, reduced median time to first exacerbation (266 days vs 174 days), frequency of exacerbations per patient year (1.83 vs 1.48), and improved quality of life (36% vs 43%). Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Int J Chron Obstruct Pulmon Dis 2008;3:331-350, 26. Lindenauer PK, Pekow P, Gao S, Crawford AS, Gutierrez B, Benjamin EM. Chest 2001;119:344-352, 2. 35. Azithromycin 250 mg 3 times a week. FEV1 denotes forced expiratory volume in 1 second, and FVC forced vital capacity. Hearing decrements were more common in the azithromycin group than in the placebo group (25% vs. 20%, P=0.04). In addition, it should be recognized that the long-term effects of this treatment on microbial resistance in the community are not known. The primary outcome was the time to the first acute exacerbation of COPD, with acute exacerbation of COPD defined as “a complex of respiratory symptoms (increased or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least 3 days requiring treatment with antibiotics or systemic steroids.”19 At each clinic visit and telephone contact, study personnel determined whether an acute exacerbation of COPD had occurred in the previous month. Tsai CL, Sobrino JA, Carmago CA Jr. National study of emergency department visits for acute exacerbation of chronic obstructive pulmonary disease, 1993-2005. There were no confidentiality agreements with the sponsor. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. We estimated that with enrollment of 1130 subjects, the study would have 90% power to show a significant difference between the two groups in the time to the first acute exacerbation of COPD, assuming that 50% of the participants in the control group19 and 40% in the azithromycin group25 would have an acute exacerbation, that the rate of nonadherence would be 20%, and that 6% of participants would die or be lost to follow-up during the study (extrapolated from Niewoehner et al.19), with a two-sided type I error of 0.05. Azithromycin for Prevention of COPD Exacerbations. 31. Kanner RE, Anthonisen NR, Connet JE. Andersson F, Borg S, Jansson SA, et al. Chest 1999;115:957-965, 16. We used a prospective, parallel-group, placebo-controlled design. document.write(new Date().getFullYear()) — both in Ann Arbor; the Division of Pulmonary and Critical Care Medicine, Department of Medicine, and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (S.C.L., P.G.W. Among selected subjects with COPD, azithromycin taken daily for 1 year, when added to usual treatment, decreased the frequency of exacerbations and improved quality of life but caused hearing decrements in a small percentage of subjects. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. The rate of death from respiratory causes was 2% and 1% in the two groups, respectively (P=0.48). Cultures from 56% of the participants in the azithromycin group and 59% in the placebo group who had selected respiratory pathogens cultured from their nasopharyngeal swabs at the time of enrollment were available for susceptibility testing (P=0.68); the remaining cultures were not tested because of protocol errors. Subsequent audiograms showed that hearing improved to the baseline level in 21 of the 61 participants (34%) who discontinued azithromycin and in 6 of the 19 (32%) who did not, as well as in 14 of the 37 participants (38%) who discontinued placebo and in 2 of the 8 (25%) who did not. The researchers defined treatment failure as the need to intensify treatment with systemic corticosteroids and/or antibiotics, transfer the patient to the intensive care unit or readmit the patient to the hospital after discharge, and death from any cause. The rate of death from any cause was 3% in the azithromycin group and 4% in the placebo group (P=0.87). The protocol was designed by the first author and was modified on the basis of input from the remaining authors. This decrease was accompanied by a decrease in the incidence of colonization with selected respiratory pathogens and improved quality of life, but also an increase in the incidence of colonization with macrolide-resistant organisms and an excess rate of hearing decrements of approximately 5%. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. Suzuki T, Yanai M, Yamaya M, et al. Polypill with or without Aspirin in Persons without Cardiovascular Disease, Case 2-2021: A 26-Year-Old Pregnant Woman with Ventricular Tachycardia and Shock, Post-Transcriptional Genetic Silencing of, http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm. The multicenter trial analyzed outcomes of 301 COPD patients hospitalized with an acute exacerbation. The authors' affiliations are as follows: the Medicine Service, Denver Health and Department of Medicine (R.K.A., C.S.P. Kim K, DeMets DL. No significant differences were observed in the frequency of serious adverse events or of adverse events leading to discontinuation of the study drug, but an audiogram-confirmed hearing decrement occurred in 142 of the participants receiving azithromycin (25%), as compared with 110 of those receiving placebo (20%) (P=0.04). Respir Med 1991;85:Suppl B:25-31. The costs of treating COPD in the United States. Effect of azithromycin on pulmonary function in patients with cystic fibrosis uninfected with Pseudomonas aeruginosa: a randomized controlled trial. Acute exacerbations adversely affect patients with chronic obstructive pulmonary disease (COPD). Prevention of COPD exacerbations is not the only reason, or even the main reason, to prescribe or use a COPD treatment. A life-table analysis showed that the risk of acute exacerbations of COPD was reduced among participants receiving azithromycin (P<0.001) (Figure 2). All reported results were prespecified. A small but significant between-group difference was observed in the mean age-adjusted hearing thresholds for the four sound frequencies from enrollment to month 3, with patients in the azithromycin group having more pronounced hearing decrements (see Section F in the Supplementary Appendix). NEW! The date of each acute exacerbation was taken as the date treatment was prescribed. Bronchiolitis in children Influenza Self-limiting respiratory tract and ear infections – antibiotic prescribing The subgroup analyses showed that the response to azithromycin seemed to vary according to age (≤65 vs. >65 years), smoking status (former smoker vs. current smoker), use or nonuse of oxygen, GOLD stage, and use or nonuse of inhalers. The frequency of exacerbations was 1.48 exacerbations per patient-year in the azithromycin group, as compared with 1.83 per patient-year in the placebo group (P=0.01), and the hazard ratio for having an acute exacerbation of COPD per patient-year in the azithromycin group was 0.73 (95% CI, 0.63 to 0.84; P<0.001). Nasopharyngeal swabs were obtained at 85% and 84% of the clinic visits attended by participants in the azithromycin group and placebo group, respectively. Macrolide antibiotics benefit patients with a variety of inflammatory airway diseases. QT drug lists by risk groups. It is possible that lower doses or less frequent administration could have produced similar results. Saiman L, Anstead M, Mayer-Hamblett N, et al. Since approximately 80% of our participants were taking inhaled glucocorticoids with or without long-acting beta2-agonists or long-acting muscarinic antagonists throughout the study, the ability of azithromycin to decrease the frequency of acute exacerbations would seem to be additive to these other therapies. An exacerbation is a sustained worsening of the person’s symptoms from their usual stable state, which is beyond normal day-to-day variations, and is acute in onset. The costs of exacerbations in chronic obstructive pulmonary disease (COPD). J Am Geriatr Soc 2008;56:1358-1360. This decrease was accompanied by a decrease in the incidence of colonization with selected respiratory pathogens and improved quality of life, but also an increase in the incidence of colonization with macrolide-resistant organisms and an excess rate of hearing decrements of approximately 5%. 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