Comparison of low-dose rofecoxib versus 1000 mg naproxen in patients with osteoarthritis: Results of two randomized treatment trials of six weeks duration

To compare the efficacy and safety of rofecoxib 12.5 mg once daily to naproxen 500 mg twice daily in patients > or = 40 years of age with knee or hip osteoarthritis (OA). Two identical 6-week, randomized, double-blind studies were conducted (1 in Africa, Australia, Europe, Canada, Mexico, & S...

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Bibliographic Details
Published in:Scandinavian journal of rheumatology 2002, Vol.31 (6), p.337-344
Main Authors: MYLLYKANGAS-LUOSUJÄRVI, R, LU, H. S, VRIJENS, F, MOAN, A, RODGERS, D. B, DE TORA, L, LAURENZI, M, CHEN, S. L, CHOON, D, AMANTE, C, CHOW, C. T, PASERO, G, GENTI, Gy, SAREMBOCK, B, ZERBINI, C. A. F
Format: Article
Language:English
Subjects:
Aged
Biological and medical sciences
Bones, joints and connective tissue. Antiinflammatory agents
Cyclooxygenase Inhibitors - administration & dosage
Cyclooxygenase Inhibitors - pharmacology
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Humans
Lactones - administration & dosage
Lactones - pharmacology
Male
Medical sciences
Middle Aged
Naproxen - administration & dosage
Naproxen - pharmacology
Osteoarthritis, Hip - drug therapy
Osteoarthritis, Hip - pathology
Osteoarthritis, Knee - drug therapy
Osteoarthritis, Knee - pathology
Pharmacology. Drug treatments
Sulfones
Treatment Outcome
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Summary:To compare the efficacy and safety of rofecoxib 12.5 mg once daily to naproxen 500 mg twice daily in patients > or = 40 years of age with knee or hip osteoarthritis (OA). Two identical 6-week, randomized, double-blind studies were conducted (1 in Africa, Australia, Europe, Canada, Mexico, & South America; 1 in Asia). Primary endpoints were pain walking on a flat surface, patient global assessment of response to therapy, and investigator global assessment of disease status. Overall, 944 patients participated. For all efficacy endpoints, treatment effects for rofecoxib and naproxen were comparable and seen at the first measures of efficacy. Both compounds were generally well-tolerated, with an improved gastrointestinal safety profile for rofecoxib versus naproxen. CONCLUSIONS In these studies, rofecoxib 12.5 mg once daily (the lowest indicated dose) and naproxen 500 mg twice daily showed similar treatment effects in OA patients. Rofecoxib and naproxen were generally well tolerated.
ISSN:0300-9742
1502-7732
DOI:10.1080/030097402320817059