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Pharmacist, Assistant Professor of Clinical Pharmacy Endowment Pharmaceutical Chair AstraZeneca in Respiratory Health Hôpital du Sacré-Coeur de Montréal University of Montréal CP 6128, succursale Centre-ville Montréal, Québec H3C 3J7, Canada fax 514/343-6120 marie-france.beauchesne{at}umontreal.ca
Pharmacist Centre Hospitalier du Haut Richelieu St-Jean sur le Richelieu
Associate Director of Pharmacy Hôpital du Sacré-Coeur de Montréal
Assistant Professor Endowment Pharmaceutical Chair AstraZeneca in Respiratory Health Hôpital du Sacré-Coeur de Montréal University of Montréal
Published Online, April 5, 2005. www.theannals.com, DOI 10.1345/aph.1E525
Methods. This study was approved by the ethics research committee of
the Hôpital du Sacré-Coeur de Montréal (HSCM). We formed a
historical cohort of 98 patients enrolled in an outpatient COPD program of the
HSCM between 1998 and 2000. Patients with a forced expiratory volume in 1
second (FEV1) 
80% predicted and those who were regular
users of oral corticosteroids were excluded. On average, subjects were 71
years old, 54% were male, 94% had a current or previous smoking history, and
mean FEV1 was 36% of the predicted value. Data on
hospitalizations, emergency department (ED) visits, and prescribed medications
were obtained from the database of the Régie de l'assurance maladie du
Québec (Canada), and baseline data were collected from the patients'
charts.
Results. The primary outcome of this study was the number of exacerbations during the study period (median follow-up time 1.1 y), which was based on 4 different markers (prescriptions of antibiotics and oral corticosteroids, hospitalizations and ED visits for respiratory illness). A delay of 2 weeks was necessary between 2 markers of an exacerbation to consider them as 2 independent events. Secondary outcomes were hospitalizations and ED visits, with each considered a separate outcome. Patients were categorized in 3 different groups based on refills, with doses indicated as beclomethasone dipropionate (BDP) chlorofluorocarbon equivalent. Regular users of ICS (n = 63) corresponded to the refill of at least one canister of BDP (250 µg/inhalation, 200 doses/canister) every 2 months, irregular users (n = 21) filled less than one canister per 2 months, and patients who did not fill a prescription for ICS during the study period were considered non-users (n = 14). The main results of this study are outlined in Table 1.
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Discussion. Because an insufficient number of non-users of ICS was obtained, irregular users and non-users were combined. We also conducted a separate analysis to exclude patients with bronchial reversibility (Table 1). Poisson regression models were used to estimate the adjusted rate ratios of exacerbations. Disease severity (FEV1); oxygen therapy; dyspnea; type of COPD; reversibility; use of short- and long-acting ß2-agonists, ipratropium, and theophylline; comorbidity; body mass index; smoking history; age; and gender were considered potential confounders. We did not find a reduction in the rate of exacerbations in regular users of ICS. A reduction in the rate of ED visits for all patients was the only result to reach statistical significance, but the rate ratios were no longer significant when patients with bronchial reversibility were excluded. This observational study included only a small number of patients, and combining non-users with irregular users is a potential confounder. Our main result is different from some placebo-controlled clinical trials that have shown a reduction in the rate of exacerbations with ICS use in patients with COPD.2-4
Footnotes
Ministère de la santé et des services sociaux du Québec and Bayer Canada, Inc. have provided funding for the conduct of this project. Dr. Blais is the recipient of a New Investigator salary support grant from the Canadian Institutes for Health Research (CIHR).
This work was presented as an abstract at the American Thoracic Society 98th International Conference, May 2002, San Francisco.
References
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