Little risk of serious GI toxicity" with OTC ibuprofen
Intermittent use of low-dose ibuprofen does not increase the risk of serious gastrointestinal (GI) toxicity for most people, say investigators at Stanford University , California (J Rheumatol 2003;30:2226-33). Their study provides scientifically robust evidence of the low risk associated with OTC ibuprofen.

The investigators determined the rates of serious GI events (e.g. GI bleeding, gastritis, GI-related admission to hospital) among 5692 patients with rheumatoid arthritis (RA) and 3124 patients with osteoarthritis (OA), who had taken ibuprofen, aspirin or paracetamol over a 6- month period.

In patients who were not taking other NSAIDs or corticosteroids, the three analgesics were associated with similarmodest rates of serious GI events per 1000 patient-years of use (ibuprofen: 3.1 for RA patients and 2.4 for OA patients; aspirin, 4.0 and 2.9; paracetamol, 2.6 and 2.1). Event rates were higher among patients who were also taking concurrent NSAIDs treated with other analgesics or corticosteroids but still not significantly different. However the rate of serious GI toxicity in these patients was significantly greater with paracetamol (15.0 per 1000 patient-years for RA and 12.0 for OA patients) than with ibuprofen (6.1 and 5.4) or aspirin (8.7 and 4.7). This finding could not be explained by preferential use of paracetamol by patients at increased risk and the investigators admitted it was a surprise.

Outcomes were then analysed according to the dose of analgesic; for ibuprofen, the categories were up to 100 mg/day, 101 - 1100 mg/day, 1101 - 2200 mg/day and over 2200 mg/day. The investigators assumed that the lowest daily doses were most likely to reflect intermittent use of OTC ibuprofen. Numbers were too small to estimate dose-response relationships but for ibuprofen there was evidence to distinguish between low and high doses. Event rates tended to be higher at doses of >2200 mg/day, and this difference was statistically significant for patients with RA who were taking NSAIDs and corticosteroids.

Overall, the investigators concluded that serious GI toxicity in these patients was largely attributable to known risk factors, such as other drug therapy and a history of GI disease. Among people taking analgesics alone at the lowest doses, there were 'low or even no GI event rates' - only one event occurred in either RA or OA patients in over 900 patient-years of use. This study supports the relative safety of ibuprofen, aspirin and paracetamol at OTC doses, the investigators conclude, particularly in patients not taking other drugs for their arthritis.

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