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


METHODS
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.


RESULTS
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.
Myllykangas-Luosujärvi
R
R
Kuopio University Hospital, Kuopio, Finland.
Lu
H S
HS
Chen
S L
SL
Choon
D
D
Amante
C
C
Chow
C T
CT
Pasero
G
G
Genti
Gy
G
Sarembock
B
B
Zerbini
C A F
CA
Vrijens
F
F
Moan
A
A
Rodgers
D B
DB
De Tora
L
L
Laurenzi
M
M
D000368:Aged; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage* / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007783:Lactones / Q000008:administration & dosage* / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000008:administration & dosage* / Q000494:pharmacology*; D015207:Osteoarthritis, Hip / Q000188:drug therapy* / Q000473:pathology; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000473:pathology; D013450:Sulfones; D016896:Treatment Outcome
D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D009288:Naproxen