Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: a randomized controlled trial.

Abstract

OBJECTIVE:

To compare the efficacy and safety of celecoxib, a cyclooxygenase-2 (COX-2) inhibitor, with those of naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and placebo in the treatment of osteoarthritis of the knee.

METHODS:

In this multicenter, randomized, double-blind, placebo-controlled trial, 1003 patients with symptomatic osteoarthritis of the knee were randomly assigned to receive celecoxib at doses of 50, 100, or 200 mg twice a day; naproxen, 500 mg twice a day; or placebo for 12 weeks. Patients were evaluated with standard measures of efficacy 2 to 7 days after discontinuing previous NSAID or analgesic therapy and after 2, 6, and 12 weeks of treatment with the study drug.

RESULTS:

Celecoxib treatment led to significant improvement in the signs and symptoms of osteoarthritis as determined by all efficacy measures. Significant pain relief occurred within 2 days of the initiation of treatment, and maximum anti-inflammatory and analgesic activity, evident within 2 weeks, was sustained throughout the 12-week study. All celecoxib doses were efficacious compared with placebo, although the 50-mg twice-daily dosage regimen was minimally effective. The higher doses of celecoxib (100 and 200 mg twice a day) were similarly efficacious, and the magnitude of improvement observed with these dosing regimens was comparable to that seen with naproxen at a dose of 500 mg twice a day. All doses of celecoxib and naproxen were well tolerated.

CONCLUSION:

COX-2 inhibition with celecoxib is an effective approach for the treatment of osteoarthritis, as seen by clinical improvement in signs and symptoms comparable to treatment with naproxen.

• Authors: W G Bensen, J J Fiechtner, J I McMillen, W W Zhao, S S Yu, E M Woods, R C Hubbard, P C Isakson, K M Verburg, G S Geis
• Journal: Mayo Clinic proceedings (Mayo Clin Proc) Vol. 74 Issue 11 Pg. 1095-105 (Nov 1999) ISSN: 0025-6196 [Print] England
• PMID: 10560596 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Cyclooxygenase 2 Inhibitors
• Cyclooxygenase Inhibitors
• Isoenzymes
• Membrane Proteins
• Pyrazoles
• Sulfonamides
• Naproxen
• Cyclooxygenase 2
• PTGS2 protein, human
• Prostaglandin-Endoperoxide Synthases
• Celecoxib

Topics

• Adult
• Aged
• Aged, 80 and over
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects, therapeutic use)
• Celecoxib
• Cyclooxygenase 2
• Cyclooxygenase 2 Inhibitors
• Cyclooxygenase Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Humans
• Incidence
• Isoenzymes (drug effects)
• Membrane Proteins
• Middle Aged
• Naproxen (therapeutic use)
• Osteoarthritis (drug therapy)
• Prostaglandin-Endoperoxide Synthases (drug effects)
• Pyrazoles
• Sulfonamides (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome