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1Department of Pulmonology, Isala klinieken, Zwolle 2Department of Pulmonology, University Medical Center Groningen, Groningen
y.p.de.jong{at}isala.nl
Abstract
Background: Treatment with systemic corticosteroids for exacerbations of COPD results in improvement in clinical outcomes. Upon hospitalization, corticosteroids are generally administered intravenously. It has not been established whether oral administration is equally effective. We conducted a study to demonstrate the non-inferiority of oral as compared with intravenous prednisolone using a double-blind, double-dummy design.
Methods: Patients hospitalized for an exacerbation of COPD were randomized to 5 days of 60 mg prednisolone intravenously or orally. Treatment failure, the primary outcome, was defined as death, admission to ICU, readmission for COPD, or intensification of pharmacological therapy during a 90-day follow-up.
Results: 435 patients were referred for a COPD exacerbation warranting hospitalization; 107 patients were randomized to intravenous and 103 to oral therapy. Overall treatment failure within 90 days was similar: 61.7% on intravenous and 56.3% on oral prednisolone (one-sided 95% confidence lower bound of the difference -5.8%). There were also no differences in early (within 2 weeks) treatment failure (17.8% and 18.4%, respectively, one-sided 95% confidence lower bound -9.4%), late (after 2 weeks) treatment failure (54.0% and 47.0%, one-sided 95% confidence lower bound -5.6%), and length of hospital stay (11.9±8.6 and 11.2±6.7 days). Over 1 week clinically relevant improvements were found in spirometry and health related quality of life, without significant differences between the two treatment groups.
Conclusion: Oral prednisolone is not inferior to intravenous treatment in the first 90 days after starting therapy. We suggest that the oral route is preferable in the treatment of COPD exacerbations.
Trial registration: Clinicaltrials.gov Identifier: NCT00311961
Key Words: COPD Exacerbation Prednisolone Oral Intravenous
Related Editorial
Chest 2007 132: 1728-1729.
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D. P. Tashkin Oral vs IV Corticosteroids for In-hospital Treatment of COPD Exacerbations Chest, December 1, 2007; 132(6): 1728 - 1729. [Full Text] [PDF] |
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