NEW YORK (Reuters Health) - In a tolerability study involving healthy volunteers, treatment with licofelone, an experimental combined inhibitor of 5-lipoxygenase and cyclooxygenase (COX-1/COX-2), was associated with significantly fewer gastrointestinal (GI) side effects than treatment with naproxen.
This study provides “convincing evidence for the superior gastro/duodenal tolerability of licofelone compared with naproxen, and therefore indicates that licofelone has a potential GI safety advantage over conventional NSAID therapy,” investigators report in the April issue of The American Journal of Gastroenterology.
In a 4-week trial, Dr. Peter Bias from Merckle GmbH in Ulm, Germany and colleagues randomized 121 healthy individuals to licofelone 200 or 400 mg b.i.d., naproxen 500 mg b.i.d., or placebo.
At the end of 4 weeks, endoscopy revealed ulcers in 20% of naproxen-treated subjects compared with none of the licofelone- or placebo-treated subjects. “These results were significant, even with the small groups of approximately 30 volunteers per treatment arm,” the authors note.
Post-treatment gastric Lanza scores -- a measure of the integrity of the gastrointestinal mucosa --confirmed the “significantly superior gastric tolerability” of both licofelone doses compared with naproxen (p<0.00001), according to the team.
The gastric mucosa was normal in 93%, 89%, and 90% of subjects following licofelone 200 mg, licofelone 400 mg, or placebo, respectively, compared with 37% of subjects receiving naproxen. There were no serious adverse events in any of the three treatment arms.
The researchers also note that preliminary results from a 12-week study of patients with osteoarthritis appear to confirm the superior GI tolerability of licofelone over naproxen, with 1.5% of those taking licofelone 200 mg b.i.d, developing ulcers compared with 15.3% of those taking naproxen 500 mg b.i.d.
Source: Am J Gastroenterol 2004;99:611-618. [ Google search on this article ]
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