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Effect of specific COX-2 inhibition in osteoarthritis of the knee: a 6 week double blind, placebo controlled pilot study of rofecoxib. Rofecoxib Osteoarthritis Pilot Study Group.

AbstractOBJECTIVE:
To determine the efficacy and safety of the cyclooxygenase 2 (COX-2) specific inhibitor, rofecoxib in patients with osteoarthritis (OA) of the knee.
METHODS:
Rofecoxib, 25 mg or 125 mg once daily, was compared with placebo in a 6 week, double blind, parallel group, randomized, multicenter study of 219 patients with knee OA.
RESULTS:
Both doses of rofecoxib produced clinically significant improvement as assessed by primary (e.g., WOMAC Pain Subscale 0-100 mm, decrease from baseline: placebo: 7.1 mm; rofecoxib 25 mg: 28.1 mm, rofecoxib 125 mg: 28.0 mm; p < 0.001 rofecoxib vs placebo) and secondary efficacy (p < 0.05) criteria compared with placebo. Clinical improvement with the 25 mg dose was similar to that with the 125 mg dose. Both rofecoxib doses were generally well tolerated.
CONCLUSION:
Specific inhibition of COX-2 by 25 and 125 mg rofecoxib, administered once daily, resulted in clinically meaningful improvements in patients with OA. This study confirms that COX-2 derived prostanoids are important clinical mediators of pain and other symptoms of knee OA and that inhibition of COX-1 is not required to provide clinical benefit.
AuthorsE W Ehrich, T J Schnitzer, H McIlwain, R Levy, F Wolfe, M Weisman, Q Zeng, B Morrison, J Bolognese, B Seidenberg, B J Gertz
JournalThe Journal of rheumatology (J Rheumatol) Vol. 26 Issue 11 Pg. 2438-47 (Nov 1999) ISSN: 0315-162X [Print] Canada
PMID10555907 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Cyclooxygenase 2 Inhibitors
  • Cyclooxygenase Inhibitors
  • Isoenzymes
  • Lactones
  • Membrane Proteins
  • Sulfones
  • rofecoxib
  • Cyclooxygenase 2
  • PTGS2 protein, human
  • Prostaglandin-Endoperoxide Synthases
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Cyclooxygenase 2
  • Cyclooxygenase 2 Inhibitors
  • Cyclooxygenase Inhibitors (adverse effects, therapeutic use)
  • Double-Blind Method
  • Female
  • Humans
  • Isoenzymes (metabolism)
  • Lactones (adverse effects, therapeutic use)
  • Male
  • Membrane Proteins
  • Middle Aged
  • Osteoarthritis, Knee (drug therapy, enzymology, metabolism)
  • Pilot Projects
  • Prostaglandin-Endoperoxide Synthases (metabolism)
  • Sulfones
  • Treatment Outcome

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