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

AbstractOBJECTIVE:
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.
AuthorsW 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
JournalMayo Clinic proceedings (Mayo Clin Proc) Vol. 74 Issue 11 Pg. 1095-105 (Nov 1999) ISSN: 0025-6196 [Print] UNITED STATES
PMID10560596 (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

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