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Source: http://www.rtmagazine.com/reuters_article.asp?id=20090827clin018.html
No excess pneumonia risk with budesonide for COPD
Last Updated: 2009-08-27 18:30:03 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Inhaled budesonide is safe to use for chronic obstructive pulmonary disease (COPD) and does not increase the risk of pneumonia, researchers have found.
Their finding comes from a meta-analysis published August 29 in an issue of The Lancet devoted entirely to COPD.
The authors, led by Dr. Don D. Sin from the University of British Columbia, Vancouver, Canada, point out that clinical trial and observational data, as well as a separate recent meta-analysis, have suggested that inhaled corticosteroids increase the risk of community-acquired pneumonia in COPD patients, particularly at high doses. However, they maintain, these studies had a number of "important limitations."
To investigate further, the investigators reviewed seven large studies of inhaled budesonide (320 to 1280 micrograms per day), with or without the long-acting beta antagonist formoterol, compared with control treatments (placebo or formoterol alone).
Unlike most prior research teams, Dr. Sin's group had access to individual patient-level data through the AstraZeneca clinical trials database and therefore was able to control for potential confounders, such as age, symptoms and lung function.
In total, they analyzed data from 7042 patients with stable COPD and at least 6 months follow up from 30 countries, of whom 3801 were on inhaled budesonide and 3241 were on control treatment, with 5212 patient-years of exposure to treatment.
Twelve months of treatment with budesonide did not increase the risk of pneumonia in patients with COPD "and therefore is safe for clinical use in such patients," Dr. Sin and colleagues conclude.
Overall, they report, the 1-year risk of pneumonia was low in both groups at about 3%, which is consistent with other large-scale COPD studies.
Increasing age and decreasing lung function were the only two variables significantly associated with the occurrence of pneumonia as an adverse or serious adverse event.
In an accompanying commentary, Dr. Tobias Welte from Medizinische Hochschule in Hannover, Germany, concludes that, for the moment, "there is no reason to deviate from the current guideline recommendations for the use of inhaled corticosteroids in COPD."
Lancet 2009;374:668-670,712-719.
No excess pneumonia risk with budesonide for COPD
Last Updated: 2009-08-27 18:30:03 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Inhaled budesonide is safe to use for chronic obstructive pulmonary disease (COPD) and does not increase the risk of pneumonia, researchers have found.
Their finding comes from a meta-analysis published August 29 in an issue of The Lancet devoted entirely to COPD.
The authors, led by Dr. Don D. Sin from the University of British Columbia, Vancouver, Canada, point out that clinical trial and observational data, as well as a separate recent meta-analysis, have suggested that inhaled corticosteroids increase the risk of community-acquired pneumonia in COPD patients, particularly at high doses. However, they maintain, these studies had a number of "important limitations."
To investigate further, the investigators reviewed seven large studies of inhaled budesonide (320 to 1280 micrograms per day), with or without the long-acting beta antagonist formoterol, compared with control treatments (placebo or formoterol alone).
Unlike most prior research teams, Dr. Sin's group had access to individual patient-level data through the AstraZeneca clinical trials database and therefore was able to control for potential confounders, such as age, symptoms and lung function.
In total, they analyzed data from 7042 patients with stable COPD and at least 6 months follow up from 30 countries, of whom 3801 were on inhaled budesonide and 3241 were on control treatment, with 5212 patient-years of exposure to treatment.
Twelve months of treatment with budesonide did not increase the risk of pneumonia in patients with COPD "and therefore is safe for clinical use in such patients," Dr. Sin and colleagues conclude.
Overall, they report, the 1-year risk of pneumonia was low in both groups at about 3%, which is consistent with other large-scale COPD studies.
Increasing age and decreasing lung function were the only two variables significantly associated with the occurrence of pneumonia as an adverse or serious adverse event.
In an accompanying commentary, Dr. Tobias Welte from Medizinische Hochschule in Hannover, Germany, concludes that, for the moment, "there is no reason to deviate from the current guideline recommendations for the use of inhaled corticosteroids in COPD."
Lancet 2009;374:668-670,712-719.