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The use of the antibiotic azithromycin in addition to conventional care may reduce treatment failure in high-risk hospitalized patients for acute exacerbation of chronic obstructive pulmonary disease, according to new data from the BACE trial.
Belgian researchers have tested a strategy of adding 500 mg of low-dose azithromycin daily to the standard care prescribed during their stay in the hospital and to continue the antibiotic at a dose of 250 mg two once a week for 3 months after hospitalization, compared to conventional care only, including systemic corticosteroids and antibiotics.
In Belgium, among the 301 patients in 20 hospitals in Belgium, the treatment failure rate was 49% in the randomized group with azithromycin and 60% in the placebo group ( HR = 0.73, 95% CI, 0.53 to 1.01). Treatment failure, the primary endpoint of the BACE study, was defined as follows: the need to intensify treatment with systemic corticosteroids and / or antibiotics; transfer to the USI or readmission to the hospital; and the death of any cause.
However, the researchers noted that the 18% reduction in the rate of treatment failure within 3 months of hospitalization in the azithromycin group was not significant because the BACE trial was malnourished due to an early termination after the test did not reach the enrollment goal of 500 patients. participants.
"Although formally negative, our results show that a low-dose azithromycin intervention initiated at the onset of a serious illness [acute exacerbation] in the case of COPD requiring hospitalization and then administered for 3 months, can greatly reduce the number of exacerbations, particularly those leading to hospitalization and transfer to intensive care in patients at risk. Long-term treatment, however, seems necessary to maintain the clinical benefits, Kristina Vermeersch, MSc, KU Leuven Department of Chronic Diseases, Metabolism and Aging and the Department of Respiratory Diseases at University Hospitals, Leuven, Belgium and colleagues American Journal of Medicine Respiratory and Critical Care.
In the other results, the rate of intensification of treatment in 3 months was 47% with azithromycin versus 60% with placebo (P = .0272). Patients in the azithromycin group spent 24% fewer days in the hospital and 74% fewer days in the ICU compared to the placebo group. The all-cause mortality rate during the study period was lower in patients badigned to azithromycin: 2% versus 4% (P = .5023). The mortality rate for respiratory causes was 0% in the azithromycin group versus 2% in the placebo group (P = 2479), and mortality from cardiovascular causes was 2% versus 1%, respectively (P = .6783). No significant prolongation of the QTc interval was observed among patients badigned to azithromycin.
The researchers also found that the benefits of azithromycin treatment were more pronounced in patients who did not smoke. The results indicate that those who reported smoking currently have little or no benefit from low-dose azithromycin treatment.
Azithromycin was well tolerated in this patient population. The frequency of adverse events leading to discontinuation of treatment was not significantly different between the two treatment groups.
After studying the effects of azithromycin weaning after 3 months, the clinical benefits of antibiotic treatment were lost at 6 months, according to the researchers.
Patients in the BACE trial were recruited and randomly badigned within 48 hours of admission to the hospital. All patients had been diagnosed with COPD, at least one exacerbation of this disease treated with systemic steroids and / or antibiotics in the past year, past or current smoking history, and normal QT interval. The average age of patients was 66.5 years and most were men.
The researchers' objective was to determine whether targeting high-risk COPD patients for a limited period of time – rather than the widespread use of azithromycin as a chronic preventative treatment for exacerbations – was beneficial, according to Wim Janssens, MD, PhD, Professor of Medicine at KU Leuven and Pulmonologist at the University Hospital of Leuven, Belgium.
"We wanted to establish a new treatment option for acute exacerbations with hospitalization, with current treatments clearly inadequate," he said in a press release issued by the American Thoracic Society. "Equally important, we wanted to see if the continuation of azithromycin for a relatively short period after leaving the hospital could interrupt the vicious cycle of relapses even after stopping treatment."
Although the primary endpoint is not statistically different between treatment groups, Mr. Janssens said that the results of reducing the time spent in the hospital and in the intensive care unit constituted a "message". positive "test" in this group of high-risk COPD. He indicated that a large phase 4 study designed with the primary goal of readmission to the hospital would be needed before large-scale implementation of the BACE trial findings. – by Katie Kalvaitis
Disclosures: The study was funded by the Flemish Government Agency for Innovation through Science and Technology, the Belgian Respiratory Protection Society and TEVA, Belgium. Janssens indicates that he is supported as Senior Clinical Investigator by the Fund for Scientific Research in Flanders (Belgium) and that he has received research fees, lecturers and consultant fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline and Novartis. Vermeersch says she is being supported as a PhD candidate by the Flemish Government Agency for Innovation through Science and Technology (Belgium).
The use of the antibiotic azithromycin in addition to conventional care may reduce treatment failure in high-risk hospitalized patients for acute exacerbation of chronic obstructive pulmonary disease, according to new data from the BACE trial.
Belgian researchers have tested a strategy of adding 500 mg of low-dose azithromycin daily to the standard care prescribed during their stay in the hospital and to continue the antibiotic at a dose of 250 mg two once a week for 3 months after hospitalization, compared to conventional care only, including systemic corticosteroids and antibiotics.
In Belgium, among the 301 patients in 20 hospitals in Belgium, the treatment failure rate was 49% in the randomized group with azithromycin and 60% in the placebo group ( HR = 0.73, 95% CI, 0.53 to 1.01). Treatment failure, the primary endpoint of the BACE study, was defined as follows: the need to intensify treatment with systemic corticosteroids and / or antibiotics; transfer to the USI or readmission to the hospital; and the death of any cause.
However, the researchers noted that the 18% reduction in the rate of treatment failure within 3 months of hospitalization in the azithromycin group was not significant because the BACE trial was malnourished due to an early termination after the test did not reach the enrollment goal of 500 patients. participants.
"Although formally negative, our results show that a low-dose azithromycin intervention initiated at the onset of a serious illness [acute exacerbation] in the case of COPD requiring hospitalization and then administered for 3 months, can greatly reduce the number of exacerbations, particularly those leading to hospitalization and transfer to intensive care in patients at risk. Long-term treatment, however, seems necessary to maintain the clinical benefits, Kristina Vermeersch, MSc, KU Leuven Department of Chronic Diseases, Metabolism and Aging and the Department of Respiratory Diseases at University Hospitals, Leuven, Belgium and colleagues American Journal of Medicine Respiratory and Critical Care.
In the other results, the rate of intensification of treatment in 3 months was 47% with azithromycin versus 60% with placebo (P = .0272). Patients in the azithromycin group spent 24% fewer days in the hospital and 74% fewer days in the ICU compared to the placebo group. The all-cause mortality rate during the study period was lower in patients badigned to azithromycin: 2% versus 4% (P = .5023). The mortality rate for respiratory causes was 0% in the azithromycin group versus 2% in the placebo group (P = 2479), and mortality from cardiovascular causes was 2% versus 1%, respectively (P = .6783). No significant prolongation of the QTc interval was observed among patients badigned to azithromycin.
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The researchers also found that the benefits of azithromycin treatment were more pronounced in patients who did not smoke. The results indicate that those who reported smoking currently have little or no benefit from low-dose azithromycin treatment.
Azithromycin was well tolerated in this patient population. The frequency of adverse events leading to discontinuation of treatment was not significantly different between the two treatment groups.
After studying the effects of azithromycin weaning after 3 months, the clinical benefits of antibiotic treatment were lost at 6 months, according to the researchers.
Patients in the BACE trial were recruited and randomly badigned within 48 hours of admission to the hospital. All patients had been diagnosed with COPD, at least one exacerbation of this disease treated with systemic steroids and / or antibiotics in the past year, past or current smoking history, and normal QT interval. The average age of patients was 66.5 years and most were men.
The researchers' objective was to determine whether targeting high-risk COPD patients for a limited period of time – rather than the widespread use of azithromycin as a chronic preventative treatment for exacerbations – was beneficial, according to Wim Janssens, MD, PhD, Professor of Medicine at KU Leuven and Pulmonologist at the University Hospital of Leuven, Belgium.
"We wanted to establish a new treatment option for acute exacerbations with hospitalization, with current treatments clearly inadequate," he said in a press release issued by the American Thoracic Society. "Equally important, we wanted to see if the continuation of azithromycin for a relatively short period after leaving the hospital could interrupt the vicious cycle of relapses even after stopping treatment."
Although the primary endpoint is not statistically different between treatment groups, Mr. Janssens said that the results of reducing the time spent in the hospital and in the intensive care unit constituted a "message". positive "test" in this group of high-risk COPD. He indicated that a large phase 4 study designed with the primary goal of readmission to the hospital would be needed before large-scale implementation of the BACE trial findings. – by Katie Kalvaitis
Disclosures: The study was funded by the Flemish Government Agency for Innovation through Science and Technology, the Belgian Respiratory Protection Society and TEVA, Belgium. Janssens indicates that he is supported as Senior Clinical Investigator by the Fund for Scientific Research in Flanders (Belgium) and that he has received research fees, lecturers and consultant fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline and Novartis. Vermeersch says she is being supported as a PhD candidate by the Flemish Government Agency for Innovation through Science and Technology (Belgium).
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