Efficacy and safety of valdecoxib in treating the signs and symptoms of rheumatoid arthritis: a randomized, controlled comparison with placebo and naproxen

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...

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Bibliographic Details
Published in:British journal of rheumatology 2002-09, Vol.41 (9), p.1008-1016
Main Authors: Bensen, W., Weaver, A., Espinoza, L., Zhao, W. W., Riley, W., Paperiello, B., Recker, D. P.
Format: Article
Language:English
Subjects:
Administration, Oral
Arthritis, Rheumatoid - drug therapy
Arthritis, Rheumatoid - physiopathology
Biological and medical sciences
Bones, joints and connective tissue. Antiinflammatory agents
COX‐2 specific inhibition
Cyclooxygenase Inhibitors - therapeutic use
Disability Evaluation
Dose-Response Relationship, Drug
Double-Blind Method
Female
Health Status
Humans
Isoxazoles - administration & dosage
Isoxazoles - therapeutic use
Joints - drug effects
Joints - physiopathology
Male
Medical sciences
Middle Aged
Naproxen - administration & dosage
Naproxen - therapeutic use
NSAIDs
Pain Measurement - drug effects
Pharmacology. Drug treatments
Prostaglandins
Rheumatoid arthritis
Self-Examination
Severity of Illness Index
Sulfonamides - administration & dosage
Sulfonamides - therapeutic use
Treatment Outcome
Valdecoxib
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Summary: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.
ISSN:1462-0324
1460-2172
1462-0332
1460-2172
DOI:10.1093/rheumatology/41.9.1008