The Pharmaceutical Journal
Vol 273 No 7316 p340
11 September 2004

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Osteoarthritis patients may benefit from new drug

Lumiracoxib, a cyclo-oxygenase 2-selective inhibitor due to be launched in the UK next year, has been shown to cause fewer ulcer complications in patients with osteoarthritis than naproxen or ibuprofen, without increasing the rate of serious cardiovascular events.

In the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), sponsored by Novartis, over 18,000 patients with osteoarthritis were randomised to lumiracoxib 400mg daily versus naproxen 500mg twice daily or ibuprofen 800mg three times daily, for 52 weeks, in two identical substudies. Low dose aspirin was also being taken by 24 per cent of patients. Patients were assessed for upper gastrointestinal ulcer complications, such as bleeding, perforation and obstruction, and for adverse cardiovascular events (myocardial infarction, stroke or cardiovascular death).

In patients not taking aspirin, the cumulative one-year incidence of ulcer complications was 1.09 per cent with the non-steroidal anti-inflammatory drugs versus 0.25 per cent with lumiracoxib (P<0.0001). This is equivalent to a four fold reduction (79 per cent). In patients taking aspirin, reductions in ulcer complications were not significant. In the overall population (aspirin and non-aspirin), ulcer complications were reduced by about three fold (66 per cent) with lumiracoxib compared with the NSAIDs.

The incidence of overall adverse cardiovascular events was not found to differ significantly between treatment groups. Patients taking lumiracoxib experienced smaller changes in blood pressure than those taking the NSAIDs. Liver function test abnormalities occurred in 2.6 per cent of patients taking lumiracoxib, compared with 0.6 per cent taking the NSAIDs. The authors say that this effect was reversible on discontinuation of the drug and point out that the lumiracoxib dose used was two or four times more than the recommended chronic dose for osteoarthritis.

The authors conclude that lumiracoxib is an appropriate treatment for patients with osteoarthritis, who are often at high cardiovascular risk (Lancet 2004;364:665 and 675).

Lumiracoxib, manufactured by Novartis, is due to be marketed as Prexige in 2005.