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COX-2 Valdecoxib Appears To Produce Only Half The Side-Effects But Shows Double The Compliance Of Non Steroidal Anti-Inflammatory Drugs

LONDON, ENGLAND -- The COX-2 Inhibitor Valdecoxib (Bextra) produces just over half the side-effects (including less ulcers) than NSAIDS and shows double the compliance, according to a new study reviewing recent data in the journal PAIN, written by researchers from the Radcliffe Hospital in Oxford.

Dr Andrew Moore, a medical researcher and editor of Bandolier concludes that "serious" adverse events with the COX- 2 valdecoxib were just over half those associated with NSAIDS.

A paper published today (Sept issue) in the journal Pain, reviewing trials conducted on doses of valdecoxib (BEXTRA™) licensed for use in osteo- and rheumatoid arthritis, including previously unpublished data, demonstrates that overall, valdecoxib has equivalent efficacy to maximum daily dose NSAIDs, mainly naproxen sodium and diclofenac.1 Patients on valdecoxib also demonstrated significantly fewer ulcers compared to patients treated with traditional NSAIDs. The authors go on to say that for every 11 patients treated with valdecoxib, one ulcer that would have occurred if a traditional NSAID had been used, would be prevented.

Efficacy findings were consistent, with valdecoxib being significantly better than placebo at 12 weeks for most outcomes. Other indicators of the tolerability of valdecoxib and safety profile include:
§ significantly lower discontinuations compared with NSAIDs because of gastrointestinal adverse events (4% versus 8 %)
§ adverse events described as 'serious' were significantly less frequent with valdecoxib (2.6%) than with traditional NSAIDs (4.5%).

Co-author of the paper, Andrew Moore comments, "There is currently much debate around the safety and efficacy of coxibs compared to non-specific, or 'traditional', NSAIDs. This meta-analysis shows valdecoxib to be a preferred option for OA and RA patients over traditional NSAIDs, requiring relief from pain and inflammation. Similar reviews of all useful clinical data will be important in the ongoing evaluation of coxib usage."

Cardiovascular safety
There has been recent debate about the effect of COX-2 inhibitors on cardiovascular events. A pooled analysis of the effects of valdecoxib on CV thrombotic events recently published in the American Journal of Therapeutics, found that at therapeutic (10 or 20mg) and supratherapeutic doses (40 or 80mg - valdecoxib is not licenced for OA and RA at these doses) for osteo- and rheumatoid arthritis, valdecoxib was not associated with an increase in events compared to the traditional NSAIDs diclofenac, naproxen sodium and ibuprofen, or placebo, in nearly 8000 patients.2


*In licensed doses for OA and RA (10 and 20mg)

References
1 Edwards JE, McQuay HJ, Moore RA. Efficacy and safety review of valdecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. Pain [citation TBC]
2 White WB, Strand V, Robert R, Whelton A. Effects of cyclooxygenase-2 specific inhibitor valdecoxib versus non-steroidal anti-inflammatory agents and placebo on cardiovascular thrombotic events in patients with arthritis. Am J Ther 2004;11(4):244-250.


SOURCE: Shire Health London

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