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| | | ![]() Using Aspirin Along with Over-the-Counter NSAIDs Increases Risk of Gastrointestinal Complications: Presented at ACG By Paula Moyer HONOLULU, HI -- November 9, 2005 -- Patients have a high risk of gastrointestinal perforations, ulcers, and bleeding when they take a low dose of aspirin daily, typically for cardiovascular prophylaxis, and then take nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs) for pain or inflammation, according to a presentation here at the 70th annual meeting of the American College of Gastroenterology (ACG). "Aspirin can significantly increase the risk of problems among patients using other over-the-counter NSAIDs," said principal investigator Joseph Biskupiak, PhD, in his presentation on November 2nd. "Even at over-the-counter doses, ibuprofen and naproxen are associated with serious gastrointestinal events, and concomitant aspirin use significantly increases that risk." Dr. Biskupiak is a Research Associate Professor, Department of Pharmacy Practice, and Director, Pharmacotherapy Outcomes Research Center, University of Utah, Salt Lake City, Utah, United States. Patients often use over-the-counter (OTC) medications concomitantly and assume that they are safe because they can be purchased without a prescription. However, both aspirin and NSAIDs are associated with gastrointestinal complications. The investigators wanted to assess the risk for perforations, ulcers and bleeds in a real-world setting among people in the United States who use OTC dosage strengths of naproxen or ibuprofen. The team compared the rates of these complications in patients who did and did not use aspirin concomitantly. They conducted a retrospective review of an electronic medical records database containing outpatient health record data for over 3.2 million individuals. The cohort included subjects who used naproxen (Aleve) at a dose of 220 mg or ibuprofen (Motrin, Advil) at a dose of 200 mg. The investigators defined the index date for each subject as the first mention of an OTC NSAID in the dataset. The investigators excluded patients who also used oral steroids or warfarin (Coumadin), as well as those who had infectious diseases, gastrointestinal (GI) cancer, enteritis, colitis, or diverticula. With these criteria, the investigators identified 11,957 subjects on naproxen and 38,507 subjects on ibuprofen. Among them, 2,328 naproxen subjects and 4,843 ibuprofen subjects used aspirin as well. The investigators analyzed the dataset for concomitant aspirin use and perforations, ulcerations, or bleeds, and conducted a pre- and post-test analysis before and after NSAID use using the subjects as their own controls. The investigators defined the NSAID index date as the defining event so that they could identify the odds ratio (OR) associated with OTC NSAID usage. The investigators also evaluated two pre-index time periods for these complications, 180 and 365 days before NSAID usage. For the post-index time period, the investigators only considered GI complications that occurred within 90 days of the OTC NSAID entry in the records. In all cases, OTC NSAID usage was associated with a statistically significant increase in the odds ratio for perforations, ulcers, and bleeds. When they used the 180-day pre-index date as the reference, ibuprofen users had an OR of 2.51 and 2.74 for naproxen (P < .00001 for both). When the 365-day pre-index date was used, the ORs were 1.38 for ibuprofen and 1.54 for naproxen (P = .01 and P = .03, respectively). When the investigators assessed the risks of concomitant aspirin usage, they found the risks for each NSAID combined with aspirin was even higher than for NSAIDs monotherapy. Subjects taking both ibuprofen and aspirin had an OR of 3.36 (P < .00001) for a perforation, ulcer or bleed, compared to subjects on ibuprofen alone, while those on naproxen plus aspirin had an OR of 2.07 (P = .005) compared to those using naproxen alone. The study was sponsored by Pfizer, which manufactures celecoxib (Celebrex). Celecoxib is a cyclo-oxygenase 2 inhibitor (COX-2 inhibitor).
[Presentation title: Gastrointestinal Complications o Over-the-Counter Nonsteroidal Anti-Inflammatory Drugs. Abstract 57]
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