Different dosing, administration of corticosteroids for severe COPD shows comparable outcomes

COPD is the fourth leading cause of death in the United States, affects more than 6 percent of adults in the U.S., and accounts for $32 billion in direct health care costs. "In 2006, there were approximately 600,000 hospital admissions for acute exacerbation COPD, making this 1 of the 10 leading causes of hospital­ization nationwide," the authors write. "Systemic corticosteroids are beneficial for patients hospitalized with acute exacerbation of COPD; however, their optimal dose and route of administration are uncertain."

Peter K. Lindenauer, M.D., M.Sc., of Baystate Medi­cal Center, Springfield, Mass., and colleagues investigated the use of cortico­steroids among patients hospitalized for acute exacerbation of COPD at 414 U.S. hospitals in 2006 and 2007. The researchers com­pared the outcomes of those initially treated with low doses of steroids ad­ministered orally to those initially administered steroids at higher doses intravenously during the first 2 hospital days. Among the outcomes the researchers analyzed included a composite measure of treatment failure, defined as the initiation of mechanical ventilation after the second hospital day, inpatient mor­tality, or readmission for acute exacerbation of COPD within 30 days of discharge.

Of 79,985 patients, 73,765 patients (92 percent) were initially treated with higher doses of steroids administered intravenously, while 6,220 (8 percent) began low doses of steroids given orally. A total of 1.4 percent of patients initially treated with intravenous steroids died during the hospitalization and 10.9 percent experienced the com­posite treatment failure outcome, whereas 1.0 percent of orally treated patients died during the hospitalization and 10.3 percent experienced the compos­ite outcome. A total of 1,356 patients (22 percent) initially treated with low-dose oral steroids were later switched to in­travenous therapy.

The researchers found that in analysis that adjusted for various factors including patient, hospital, and physician characteris­tics, the risk of treatment failure among patients given low doses of steroids orally was not sig­nificantly different from those treated with high-dose steroids intravenously. Also, pa­tients treated with low doses of ste­roids administered orally had shorter lengths of hospital stay and lower costs.

"In this large observational study, we found that, in sharp contrast to the rec­ommendations contained in leading clinical guidelines, the vast major­ity of patients hospitalized for acute exacerbation of COPD were initially treated with high doses of corticoste­roids administered intravenously. This practice does not appear to be associ­ated with any measurable clinical ben­efit and at the same time exposes patients to the risks and inconvenience of an intravenous line, potentially unnec­essarily high doses of steroids, greater hospital costs, and longer lengths of stay," the authors write.

"In light of the greater risks and higher costs as­sociated with high-dose intravenous treatment, opportunities may exist to improve care by promoting greater use of low-dose steroids given orally. Given the large numbers of patients hospital­ized with COPD each year in the United States, a clinical trial comparing these 2 approaches to management would be valuable."

Editorial: Acting on Comparative Effectiveness Research in COPD

Jerry A. Krishnan, M.D., Ph.D., of the University of Chicago, and Richard A. Mularski, M.D., M.S.H.S., M.C.R., of Kaiser Permanente and Oregon Health and Science University, Portland, write in an accompanying editorial that given the impracticality of testing every clinical intervention in large-scale clinical trials, greater use of linked registries may serve as the basis for rigorous observational comparative effectiveness research studies, like those by Lindenauer and colleagues.

"In the case of oral corticoste­roids for exacerbations of COPD, the data are sufficient to take action to change practice now. To ensure that potential ben­efits supported by observational data are realized, further follow-up evaluations are needed to measure time-trends in quality metrics, health outcomes, and health care costs."