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at time of writing, Senior Researcher, Center for Health Care Policy and Evaluation, Eden Prairie, MN; now, Pharmacoepidemiologist, GlaxoSmithKline, Oakville, ON, Canada
Epidemiologist, Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD
Biostatistician, Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration
Associate Director for Science, Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration
Reprints: Dr. Graham, Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Ln., HFD-400, Rockville, MD 20857-0001, fax 301/443-9664, grahamd{at}cder.fda.gov
BACKGROUND: The cyclooxygenase-2 (COX-2) selective nonsteroidal antiinflammatory drugs (NSAIDs) celecoxib and rofecoxib (before its removal) are marketed as having fewer gastrointestinal (GI)-related complications than nonselective NSAIDs. However, adverse reaction data suggest that the use of COX-2 selective NSAIDs is associated with clinically significant GI events.
OBJECTIVE: To assess whether patients receiving celecoxib and rofecoxib have a greater underlying disease burden than patients prescribed nonselective NSAIDs.
METHODS: The study population consisted of members of 11 health plans, aged >34 years, with a pharmacy claim for celecoxib or rofecoxib or a nonselective NSAID dispensed between February 1, 1999, and July 31, 2001, who had been continuously enrolled for >364 days before the dispensing date. Celecoxib and rofecoxib patients were randomly selected without replacement from a pool of eligible users in each of the 30 months. Nonselective NSAID users were randomly chosen without replacement within each month on a 2:1 ratio to cases; they could be chosen in more than one month. Univariate analyses comparing 9000 cases and 18 000 controls were performed, followed by a multiple logistic regression analysis conditioned on time.
RESULTS: Increasing age, treatment by a rheumatologist or an orthopedic specialist, treatment with a high number of different medications in the past year, treatment with oral corticosteroids in the past year, and having had a previous GI bleed increased the likelihood of receiving celecoxib or rofecoxib, whereas treatment with a high number of nonselective NSAID prescriptions in the past year decreased it. Treatment with a high number of different medications was a predictor of increased prevalence of underlying diabetes mellitus and cardiovascular disease.
CONCLUSIONS: Patients having a greater underlying disease burden were more likely to receive COX-2 selective NSAIDs than nonselective ones. Paradoxically, patients at higher risk for cardiovascular disease were channeled toward treatment with COX-2 selective NSAIDs, many of which may confer an increased risk of acute myocardial infarction and other adverse cardiovascular outcomes.
Key Words: celecoxib, cyclooxygenase-2 inhibitors, determinants of prescribing, disease burden, nonsteroidal antiinflammatory drugs, rofecoxib
Published Online, March 8, 2005. www.theannals.com, DOI 10.1345/aph.1E298
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  V. Schneider, L. E. Levesque, B. Zhang, T. Hutchinson, and J. M. Brophy Association of Selective and Conventional Nonsteroidal Antiinflammatory Drugs with Acute Renal Failure: A Population-based, Nested Case-Control Analysis Am. J. Epidemiol., November 1, 2006; 164(9): 881 - 889. [Abstract] [Full Text] [PDF]
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