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PO Is OK for COPD Follow the Guidelines!
Abstract & Commentary
By Barbara A. Phillips, MD, MSPH, Professor of Medicine, University of Kentucky; Director, Sleep Disorders Center, Samaritan Hospital, Lexington. Dr. Phillips is a consultant for Cephalon, and serves on the speakers bureaus for Resmed and Respironics.This article originally appeared in the August 15, 2010 issue of Internal Medicine Alert. It was edited by Stephen A. Brunton, MD, and peer reviewed by Gerald Roberts, MD. Dr. Brunton is Adjunct Clinical Professor, University of North Carolina, Chapel Hill, and Dr. Roberts is Assistant Clinical Professor of Medicine, Albert Einstein College of Medicine, New York, NY. Dr. Brunton is a consultant for Novo Nordisk, Shionogi Pharma, and Takeda, receives grant/research support and serves on the speaker's bureau for Novo Nordisk. Dr. Roberts reports no financial relationships relevant to this field of study.
Synopsis: There is no difference in rates of treatment failure, death, or readmission for COPD between patients treated with oral or intravenous steroids for exacerbation of COPD, but the IV route may be associated with increased cost and length of stay.
Source: Lindenauer PK, et al. Association of corticosteroid dose and route of administration with risk of treatment failure in acute exacerbation of chronic obstructive pulmonary disease. JAMA. 2010;303:2359-2367.
Although systemic steroids are widely used and accepted as part of the routine treatment of COPD exacerbations, very little is known about the best route of administration or optimal dose in patients hospitalized for COPD exacerbations. The aim of this study was to compare the outcomes of patients treated with low doses of oral steroids to those treated with higher doses of intravenous (IV) steroids. The study was carried out at 414 geographically diverse U.S. hospitals during 2006 and 2007. To be included in the study, patients had to be 40 years or older, have a principal diagnosis of COPD, or respiratory failure with acute exacerbation of COPD. They were excluded if they were admitted directly to the intensive care unit, had a secondary diagnosis of pneumonia or pulmonary embolism, were admitted for only only day, or were transferred to or from another acute care facility. In addition to patient age, sex, race/ethnicity, and insurance status, the authors were able to collect data about many other comorbidities and hospitalization history, as well as treatment during the hospitalization of interest for this study.
Patients were categorized in the high-dose IV therapy group if their first recorded dose of corticosteroids was given IV and was within a 120-800 mg/day range of the equivalent of prednisone. Patients were considered to be in the low-dose oral treatment group if they were initially treated with between 20 and 80 mg/day of prednisone by mouth. The main outcome variables were treatment failure (defined as requiring mechanical ventilation after the second hospital day), inpatient mortality, or readmission for acute exacerbation of COPD within 30 days of discharge. The authors also investigated length of stay and cost.
During the two years of study, 79,985 patients met criteria for inclusion in this analysis. A total of 73,765 (92%) were initially treated with IV steroids. There were no differences in outcomes according to route and dose of corticosteroid; 1.4% of the intravenously and 1.0% of the orally treated patients died during the hospitalization; 10.9% of the intravenously and 10.3% of the orally treated patients experienced at least one of the following: treatment failure, death during the hospitalization, or readmission for COPD within 30 days of discharge. Adjusting for confounders did not change these findings. The authors also undertook an analysis based on the likelihood of being treated with low-dose oral steroids; this model included such things as attending specialty, treatment patterns by hospital, and other treatments. In this propensity-matched analysis, the risk of treatment failure, length of stay, and cost were significantly lower among orally treated patients. When compared with those in the high-dose intravenous group, patients treated with low-dose oral steroids were marginally older, included a lower proportion of white patients, and were less likely to have private insurance. Patients treated with low doses of orally administered steroids also were sicker; they were more likely to have diabetes, heart failure, anemia, and renal failure. When compared with those initially treated intravenously, those who got low-dose oral steroids were less likely to receive early treatment with antibiotics, methylxanthine bronchodilators, to undergo arterial blood gas analysis, and to receive non-invasive ventilation in the first 2 hospital days. Treatment with low-dose orally administered steroids was more common in the Northeast, at larger hospitals, and those with teaching programs. A total of 1356 patients (22%) initially treated with low-dose oral steroids were later switched to intravenous therapy.
Other interesting characteristics of this group of patients were revealed by this analysis. Their median age was 69 years, 61% were women, 73% were white, and Medicare was the most common form of health insurance. Hypertension, diabetes, heart failure, and depression were the most frequently recorded comorbidities. Of these patients, 17% had one admission for COPD in the year before the index hospitalization, and 12% had two or more. Eighty percent were admitted directly from the emergency department, and the vast majority was cared for by general internists or family physicians. The median length of stay was four days, median costs were $5,021, and 30% were hospitalized for six days or longer.
COPD exacerbation is among the top 10 leading causes of hospitalization nationwide,1 and the data here demonstrate that it is usually managed by generalists. Standard treatment includes supplemental oxygen, short-acting bronchodilators, systemic corticosteroids, and often antibiotics. Steroids have been found to improve lung function, to reduce the risk of treatment failure, and to decrease length of hospital stay for patients with COPD exacerbation,2-4 but very little work has been done comparing the efficacy of different doses and routes of administration. Clinical guidelines produced by leading professional organizations actually recommend the use of low doses of steroids given by mouth,5,6 and this study indicates that these recommendations are appropriate. Amazingly, however, this study also indicates that an overwhelming majority (more than 90%) of practitioners caring for patients with COPD exacerbation in the "real world" are ignoring these recommendations. As the authors of the current paper put it, "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."
1. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. Available at: http://hcupnet.ahrq.gov/.
2. Albert RK, et al. Controlled clinical trial of methylprednisolone in patients with chronic bronchitis and acute respiratory insufficiency. Ann Intern Med. 1980;92:753-758.
3. Davies L, et al. Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease. Lancet. 1999;354:456-460.
4. Thompson WH, et al. Controlled trial of oral prednisone in outpatients with acute COPD exacerbation. Am J Respir Crit Care Med. 1996;154(2 pt 1):407-412.
5. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD). Available at: www.goldcopd.org.
6. National Collaborating Centre for Chronic Conditions. Chronic obstructive pulmonary disease. National clinical guideline for management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax. 2004;59:1-232.