STOCKHOLM, SWEDEN — June 14, 2002 —
A new anti-inflammatory drug called licofelone is just as effective as naproxen but is associated with fewer gastrointestinal (GI) problems, according to early research in patients with osteoarthritis (OA).
COX-2 inhibitors appear to have a better gastric tolerability profile than nonsteroidal anti-inflammatory drugs (NSAIDs) with similar efficacy. However, there has been some concern that COX-2 inhibitors confer an increased thromboembolic risk. Licofelone has been shown to competitively inhibits the COX-1 and COX-2 enzymes as well as the 5-lipoxygenase (5-LOX) enzyme. Researchers hypothesize that the blocking of this additional enzyme, which is believed to play a role in the GI toxicity associated with NSAIDs, will result in fewer gastric side effects.
Two clinical, phase III studies on the safety and efficacy of licofelone were presented this week at the Annual European Congress of Rheumatology (EULAR), which is taking place here June 12-15. Both studies were led by Professor Jean-Yves Reginster, from the University of Liege in Belgium.
For the first study, 121 individuals with normal gastric and duodenal mucosa took one of four treatments for four weeks: licofelone 200 mg bid; licofelone 400 mg bid; the NSAID naproxen 500 mg bid; or a placebo.
At the end of the study, endoscopic evaluation revealed perfectly normal mucosa in 93 percent of those on the lower dose of licofelone, 89 percent of those on the higher dose of licofelone, and 90 percent of those on placebo.
No ulcers were present in any of these individuals. In contrast, only 37 percent of those who took naproxen still had normal mucosa at the end of the study. In addition, five gastric and one duodenal ulcer were observed in this group.
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