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Rheumatology 2002; 41: 1008-1016
© 2002 British Society for Rheumatology
Original papers |
Efficacy and safety of valdecoxib in treating the signs and symptoms of rheumatoid arthritis: a randomized, controlled comparison with placebo and naproxen
St Joseph's Hospital and McMaster University, Hamilton, ON, Canada,
1 Arthritis Center of Nebraska, Lincoln, NE,
2 Louisiana State University Medical Center, New Orleans, LA and
3 Clinical Research & Development, Pharmacia Corporation, Skokie, IL, USA
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 (P
0.01). 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.
KEY WORDS: COX-2 specific inhibition, Valdecoxib, Rheumatoid arthritis, NSAIDs, Prostaglandins.
Correspondence to: D. P. Recker, Clinical Research and Development, Pharmacia Corporation, 5200 Old Orchard Road, Skokie, IL 60077, USA.
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