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Abstract & Commentary
By David J. Pierson, MD, Editor , Professor, Pulmonary and Critical Care Medicine, Harborview Medical Center, University of Washington, Seattle, is Editor for Critical Care Alert .
Synopsis: This study of oral versus intravenous prednisolone in patients hospitalized with exacerbations of COPD showed no differences in any outcome variable between the two forms of administration.
Source: de Jong YP, et al. Chest. 2007 Jul 23; [Epub ahead of print] DOI 10.1378/chest.07-0208.
De Jong and colleagues in The Netherlands conducted a prospective, randomized, double-blind, double-dummy, placebo-controlled, parallel-group clinical study of intravenous vs oral corticosteroids in the treatment of patients hospitalized because of an exacerbation of chronic obstructive pulmonary disease (COPD). All patients with known COPD who were admitted to a single institution during the 2-year study period were considered for inclusion. Patients were excluded if they had asthma, significant comorbidity, poor compliance, or previous study enrollment, and also if the exacerbation was severe, as defined by arterial pH 7.25 or less or PCO 2 70 mm Hg or more. Patients received 5 days of either intravenous or oral prednisolone, 60 mg, as the active medication; they also received nebulized ipratropium and albuterol 4 times daily and oral amoxicillin-clavulanate. Prednisolone was given orally to all patients after the first 5 days, with the daily dose tapered to zero over the next week.
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. The study was designed as a non-inferiority trial, with sample sizes calculated...