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Low Risk of Gastrointestinal Toxicity with Over-The-Counter Doses of Aspirin, Acetaminophen, and Ibuprofen

The rate of serious gastrointestinal (GI) events is low in rheumatoid arthritis (RA) and osteoarthritis (OA) patients who take low-dose aspirin, acetaminophen, or ibuprofen alone; though the rates increase with concomitant NSAID and corticosteroid use, say researchers.

Chronic use of high doses of nonsteroidal anti-inflammatory drugs (NSAID) has been associated with a high incidence of serious GI events. The incidence, however, with over-the-counter use has had little study.

James F Fries, MD, and Bonnie Bruce, DrPH, MPH, RD, at Stanford University School of Medicine, Palo Alto, California, United States, evaluated the frequency of GI complications in patients taking low or intermittent doses of aspirin, acetaminophen, or ibuprofen.

The study included database information on 5,692 patients with RA and 3,124 patients with OA (36,262 patient years) who were taking over-the-counter aspirin, acetaminophen, or ibuprofen. The frequency of GI event-related hospitalisation was calculated based on the self-reported Stanford Health Assessment Questionnaire (HAQ) and hospital records.

Overall, less than 1% of OA and RA patients in each analgesic-alone group experienced a serious GI event, which was similar to background values. RA patients had a higher incidence of events than OA patients; though the study also found that RA patients tended to use NSAIDs more often and for longer a duration than OA patients.

Further analysis revealed that the rates of serious GI events were 4.0 per 1000 patient years for RA patients taking aspirin alone, 2.6 per 1000 patient years for acetaminophen alone, and 3.1 per 1000 patient years for ibuprofen alone. The same trend, but lower rates were seen for OA patients (range 2.1-2.9 per 100 patient years). Notably, the overall propensity for a serious GI event was similar across analgesic choice.

Concurrent NSAID therapy and corticosteroid use were consistently associated with higher rates of serious GI events, up 2- to 6-fold from analgesic monotherapy. Furthermore, the rate in patients taking acetaminophen with concurrent therapy and corticosteroid use was significantly higher than in patients taking either of the other NSAIDs with concurrent therapy and corticosteroid use (15 events per 1000 RA patient years and 12 events per 1000 OA patient years).

The study also revealed that lower doses of each analgesic were associated with a lower incidence of serious GI-events, though the number of events was small and standard error was large in the dose-response analysis.

The authors conclude that "over-the-counter use of aspirin, acetaminophen, and ibuprofen carries little risk of serious GI toxicity for most persons." They further state that "given the low rates of events, at low or intermittent dosage without concurrent treatment, these 3 analgesics cannot be distinguished from each other or from background rates of serious GI toxicity."

J Rheumatol 2003 Oct;30:10:2226-33. "Rates of serious gastrointestinal events from low dose use of acetylsalicylic Acid, acetaminophen, and Ibuprofen in patients with osteoarthritis and rheumatoid arthritis"

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