The Pharmaceutical Journal
Vol 269 No 7205 p10
6 July 2002

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European League Against Rheumatism (www.eular.org)

COX-2 inhibitor close to launch shows similar efficacy to traditional NSAIDs

VALDECOXIB, a new cyclo-oxygenase (COX) 2 inhibitor, provides similar pain relief to older non-steroidal anti-inflammatory drugs (NSAIDs) but with better gastrointestinal tolerability, according to trials in osteoarthritis and rheumatoid arthritis presented last month at the European League Against Rheumatism (EULAR) meeting in Stockholm.

In the osteoarthritis trial, 1,019 patients with osteoarthritis of the knee were randomly assigned to receive valdecoxib 5mg, 10mg or 20mg once daily, naproxen 50mg twice daily, or placebo, for 12 weeks. Arthritis assessments made at baseline and at two, six and 12 weeks showed that valdecoxib at doses of 10mg and 20mg was as effective as naproxen (P<0.05 versus placebo) in relieving symptoms of osteoarthritis. However, endoscopic examination showed fewer patients had ulcers with valdecoxib than with naproxen.

In the rheumatoid arthritis trial, 722 adults were randomised to receive valdecoxib 20mg or 40mg once daily or diclofenac SR 75mg twice daily. Results showed similar efficacy for both valdecoxib and diclofenac based on standard measures of patient-reported pain relief and functional ability. The incidence of endoscopically detected ulcers was 6 per cent in patients treated with 20mg valdecoxib, 4 per cent in those given 40mg valdecoxib and 16 per cent in the diclofenac group (P<0.001).

Presenting the findings, Dr Frank McKenna, consultant rheumatologist, Trafford General Hospital, Manchester, said: "The study results suggest that valdecoxib is significantly less likely to cause ulcers than diclofenac and may be an option for the long-term treatment of the pain and inflammation of rheumatoid arthritis."

Valdecoxib has faster onset of action than other agents in models of acute pain. It is currently being evaluated for marketing authorisation in the European Union, and is already approved for treating osteoarthritis, adult rheumatoid arthritis and primary dysmenorrhoea in the United States. It is being developed by Pharmacia and Pfizer and is expected to be launched in the United Kingdom later this year.