Objective: To compare the effects of continuous v intermittent celecoxib treatment in patients with knee or hip osteoarthritis (OA) in flare.
Methods: This was a 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 endpoint 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 endpoints included, among others, the percentage of days with intake of flare medication, 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 OA.
Results: There were no significant differences between patients randomised to continuous or intermittent therapy in the primary endpoint or most of the secondary endpoints, although a consistent trend supporting continuous therapy was observed. The percentage of days with intake of flare medication was significantly lower (p = 0.031) in the continuous v the intermittent celecoxib treatment group. Both treatment regimens were well tolerated.
Conclusion: 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 looking at both efficacy and safety outcomes is required for conclusive evidence in favour of either continuous or intermittent treatment.
- controlled clinical trial