Abstract | OBJECTIVE: 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.
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Authors | E W Ehrich, T J Schnitzer, H McIlwain, R Levy, F Wolfe, M Weisman, Q Zeng, B Morrison, J Bolognese, B Seidenberg, B J Gertz |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 26
Issue 11
Pg. 2438-47
(Nov 1999)
ISSN: 0315-162X [Print] Canada |
PMID | 10555907
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Cyclooxygenase 2 Inhibitors
- Cyclooxygenase Inhibitors
- Isoenzymes
- Lactones
- Membrane Proteins
- Sulfones
- rofecoxib
- Cyclooxygenase 2
- PTGS2 protein, human
- Prostaglandin-Endoperoxide Synthases
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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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