The Pharmaceutical Journal
Vol 269 No 7205 p10
6 July 2002

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European League Against Rheumatism (www.eular.org)

Osteoarthritis treatment may be safe with aspirin

A new treatment for osteoarthritis, licofelone, the first of a group of agents known as LOX-COX inhibitors, could make it possible for patients with co-existing cardiovascular risk factors to achieve effective and safe pain relief while taking aspirin, new data in rats suggest. Data were presented at the European League Against Rheumatism (EULAR) meeting in Stockholm last month.

Licofelone blocks not only cyclo-oxygenase (COX)-1 and COX-2 but also 5-lipoxygenase (LOX), so addressing the role of leukotrienes in the arthritic inflammatory process. It may also spare the gastric mucosa in patients taking aspirin, for cardiovascular risk factors, by simultaneously inhibiting LOX as well as COX pathways, researchers say.

Professor Stefano Fiorucci, associate professor of gastroenterology at the University of Perugia, Italy, said that patients taking aspirin for cardiovascular risk factors needed effective pain management with no increased risk of myocardial infarction or gastrointestinal damage and that licofelone was an appropriate treatment option. "We will have to wait for clinical data, but animal data look extremely promising," he said.

In a phase III study presented at the meeting, licofelone was shown to have equal efficacy to non-steroidal anti-inflammatory drugs such as naproxen with reductions in the risk of developing gastrointestinal damage. Researchers randomly assigned 710 patients with osteoarthritis of the knee to receive licofelone 100mg or 200mg or naproxen 500mg, twice daily. They found that all three treatments were equally effective in relieving pain.

The incidence of gastrointestinal ulcers was, however, lower in patients treated with licofelone than in those treated with naproxen.

A phase II study compared licofelone 200mg and 400mg with naproxen 500mg, twice daily, and placebo in 118 patients with knee osteoarthritis. Each patient was given an endoscopy after just four weeks of treatment.

There was no evidence of damage to the gastric mucosa in any of the patients assigned to receive licofelone or placebo. But 20 per cent of those taking naproxen had signs of ulceration.