MEDIA STATEMENT

                                                6th January 2005

Study by Graham DY et al. Visible Small Intestinal Mucosal Injury in Chronic NSAID users.

This very small American study, shortly to be published in the journal Clinical Gastroenterology and Hepatology, reports on changes in the small bowel in people being treated with an NSAID. The primary goals of the study were to test a new intestinal imaging technique and to measure the frequency of small bowel injury.   Despite the very limited number of patients which reduces the strength of the data, the authors reported injury to the lining of the small intestine among 15 of 21 people taking long-term treatment with an NSAID compared with 2 of 21 controls not taking an NSAID. Of the cases of injury in people taking an NSAID, 10 were considered mild.

It is difficult to apply the results of this study to the use of over-the-counter (OTC) ibuprofen because:

* Over-the-counter ibuprofen is indicated for occasional short-term use at low doses (maximum 1200 mg/day).

* This study included people who had been taking an NSAID for at least 3 months (without reporting the actual duration of use or excluding the recent use of other NSAIDs).

* The study included 21 people who were taking an NSAID to treat arthritis, of whom only 6 were taking ibuprofen.

o Of those taking ibuprofen, three were taking does higher than are recommended for OTC use (one was taking a dose of 1600 mg/day and two were taking 2400 mg/day).

o One person taking ibuprofen was also taking the prescription-only NSAID piroxicam together with aspirin.

* The study does not state whether the observed effects occurred in any people taking ibuprofen.

The study included participants who could take acid-suppressing drugs of the sort used to treat gastrointestinal injury. However, no information was provided about previous drug use that could have caused such problems. It is therefore possible that some people had been prescribed acid suppression therapy and switched from other NSAIDs to better tolerated alternatives such as ibuprofen because of the side effects of their initial treatment. This means that the effects observed cannot necessarily be attributed to the treatment being taken at the time of the study.

Very large published studies involving thousands of patients have shown that ibuprofen, when taken at OTC doses as directed for short-term occasional use, is as well tolerated as paracetamol or aspirin (1 - 3). The most recent of these(3) looked for serious gastrointestinal events (including gastrointestinal bleeding, ulcers and symptomatic gastritis) in 8816 patients with arthritis who were taking ibuprofen, aspirin or paracetamol occasionally or in low doses. Of these, 1207 were taking only ibuprofen. The study found that the rates of these events were so low that there was no difference between the three drugs and the background rate among people not taking a drug.

The International Ibuprofen Foundation assures consumers they can have full confidence in the use of ibuprofen-based pain medications when used according to the label. Anyone with questions or concerns about the most appropriate pain reliever should see their doctor or pharmacist.

1. Moore N., et al,. Clin Drug Invest 1999: 18 (2) 89-98

2. Rainsford K.D,. et al., J Pharm Pharmacol 1997 ; 49 :345-376

3 Fries J. et al. Journal of Rheumatology 2003 ; 30 : 2226-2233

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