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ELIZABETH BENITO-GARCIA, KALEB MICHAUD, and FREDERICK WOLFE
ABSTRACT. Methods. Using a longitudinal databank, a prospective study using Cox proportional hazards models was performed in patients receiving COX-2 therapy for RA or OA to examine the effect of ASA on GI events. In 4 separate analyses patients reported dyspeptic symptoms and GI ulcers at semiannual intervals for up to 3 years. Ulcers were validated by review of medical records. Results. Among 4240 patients taking COX-2-specific inhibitors, with no ulcer at study start, the age- and sex-adjusted hazard ratios for the effect of ASA on the development of epigastric pain, heartburn, nausea, and ulcers, without these previous events, were 1.11 (95% CI 0.97–1.29), 1.00 (95% CI 0.88–1.15), 1.32 (95% CI 1.13–1.54), and 1.27 (95% CI 0.78–2.05). The use of a propensity score to account for the risk of ASA prescription showed an even lower effect of ASA among all GI variables. This risk occurs within the setting of no prior GI symptoms or GI events, and independently of the use of proton pump inhibitors, other GI drugs, other nonsteroidal antiinflammatory drugs, prednisone, or methotrexate. Conclusion. In actual practice, the use of low-dose ASA has a small effect on the risk of developing dyspeptic symptoms in a group of patients with rheumatic disease. (First Release July 1 2007; J Rheumatol 2007;34:1765-9) Key Indexing Terms:
ASPIRIN
From the Department of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, Massachusetts; National Data Bank for Rheumatic Diseases and the University of Kansas School of Medicine, Wichita, Kansas; Center for Primary Care and Outcomes Research, Stanford University, Stanford, California, USA; and BioEPI Clinical and Translational Research Center, Oeiras, Portugal. Supported by a grant from TAP Pharmaceutical Products, Inc. The National Data Bank has received support from pharmaceutical companies including Abbott, Amgen, Bristol-Myers Squibb, Centocor, Merck, and TAP. E. Benito-Garcia, MD, MPH, Department of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Harvard Medical School and BioEPI Clinical and Translational Research Center; K. Michaud, MS, National Data Bank for Rheumatic Diseases and the Center for Primary Care and Outcomes Research; F. Wolfe, MD, National Data Bank for Rheumatic Diseases. Address reprint requests to Dr. E. Benito-Garcia, BioEPI, Clinical and Translational Research Center – Taguspark, Núcleo Central, 244, 2740-122 Oeiras, Portugal. E-mail: ebenitogarcia@bioepi.com Accepted for publication April 19, 2007. |