A prospective randomised multicentre study comparing continuous and intermittent treatment with celecoxib in patients with osteoarthritis of the knee or hip.
OBJECTIVE
To compare the effects of continuous and intermittent celecoxib treatment in patients with knee or hip osteoarthritis in flare.


METHODS
In this 24-week, prospective, randomised, double-blind, placebo-controlled study, patients were randomly assigned to receive continuous (n = 62) or intermittent (n = 61) treatment with celecoxib 200 mg once daily. The primary efficacy end point was the area under the curve (AUC) of the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total scores between baseline and week 24 divided by the time interval. Secondary end points included the percentage of days with intake of the flare drug, the AUC of the change in the WOMAC total scores, the mean change from baseline in the WOMAC scores, and the patient's and physician's global assessment of osteoarthritis.


RESULTS
There were no significant differences between patients randomised to continuous or intermittent treatment in the primary end point or most of the secondary end points, although a consistent trend supporting continuous treatment was observed. The percentage of days with intake of the flare drug was significantly lower (p = 0.031) in the group receiving continuous versus intermittent celecoxib. Both treatment regimens were well tolerated.


CONCLUSIONS
The results of this pilot study indicate a potential clinical difference between continuous and intermittent treatment with celecoxib, and may be useful in designing future trials. A larger trial on both efficacy and safety outcomes is required for conclusive evidence in favour of either continuous or intermittent treatment.
Luyten
F P
FP
Department of Rheumatology, University Hospitals KULeuven, Herestraat 49, B3000 Leuven, Belgium. frank.luyten@uz.kuleuven.ac.be
Geusens
P
P
Malaise
M
M
De Clerck
L
L
Westhovens
R
R
Raeman
F
F
Vander Mijnsbrugge
D
D
Mathy
L
L
Hauzeur
J P
JP
De Keyser
F
F
Van den Bosch
F
F
D000368:Aged; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D000068579:Celecoxib; D017024:Chemotherapy, Adjuvant; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D015207:Osteoarthritis, Hip / Q000188:drug therapy; D020370:Osteoarthritis, Knee / Q000188:drug therapy; D010865:Pilot Projects; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D013449:Sulfonamides / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; D007052:Ibuprofen