Objective: To compare the efficacy of the COX-2 specific inhibitor valdecoxib with the conventional NSAID naproxen and placebo in treating rheumatoid arthritis (RA).
Methods: This multi-centre, randomized, double-blind, placebo-controlled trial compared the efficacy and safety of valdecoxib 10 mg (n=209), 20 mg (n=212) or 40 mg once daily (q.d.) (n=221) with naproxen 500 mg b.i.d. (n=226) or placebo (n=222), in treating the signs and symptoms of RA. Efficacy was assessed by the number of patients responding to treatment according to the American College of Rheumatology-Responder Index (ACR-20).
Results ACR-20 response was recorded for all randomized patients who received a single dose of study medication (above). Valdecoxib, at all administered doses, produced significant improvements in the ACR-20 Responder Index at weeks 2, 6 and 12 compared with placebo (P0.01). Valdecoxib and naproxen did not differ in terms of ACR-20 response rate and the three doses of valdecoxib were similar to one another. All three doses of valdecoxib were well tolerated.
Conclusions: Single daily doses of valdecoxib 10, 20 and 40 mg demonstrated efficacy that was superior to placebo and similar to naproxen in treating the signs and symptoms of RA. All three doses provided similar levels of efficacy.