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Rheumatology Advance Access published online on February 3, 2004
Rheumatology, doi:10.1093/rheumatology/keh121
Rheumatology © British Society for Rheumatology 2004; all rights reserved
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© 2004 Rheumatology © British Society for Rheumatology 2004; all rights reserved

Original Papers

Celecoxib 200 mg q.d. is efficacious in the management of osteoarthritis of the knee or hip regardless of the time of dosing

K. Stengaard-Pedersen 1*, R. Ekesbo 2, A.-L. Karvonen 3, and M. Lyster 4

1 Rheumatology, Aarhus University Hospital, Aarhus, Denmark
2 Institution of Civic Medicine, Department of General Medicine, University Hospital, Malmö University of Lund, Lund, Sweden
3 Medicine, University Hospital of Tampere, Tampere, Finland
4 Pfizer ApS, Ballerup, Denmark

* Corresponding author. E-mail: stengaard{at}akh.aaa.dk.

Received 17 May 2003 ; accepted 25 November 2003

Abstract

Objectives. The primary objective was to demonstrate equivalence between a.m. and p.m. dosing of celecoxib 200 mg q.d. An equivalence assessment of q.d. vs b.i.d. dosing was a secondary objective.

Methods. In this randomized, double-blind study, patients with symptomatic osteoarthritis of the knee or hip were randomized to receive celecoxib 200 mg q.d. a.m., celecoxib 200 mg q.d. p.m. or celecoxib 100 mg b.i.d. The primary outcome variable, measured at week 12 on a 0- to 10-point integrated scale, was patient satisfaction assessment (pain relief, walking/bending, and willingness to continue medication). Equivalence was declared if the 95% confidence interval (CI) of the difference (a.m. q.d. vs p.m. q.d., b.i.d. vs q.d.) fell within the interval of -2 to +2.

Results. A total of 697 patients were enrolled in this trial. For the a.m. vs p.m. comparison, the 95% CIs were within the prespecified equivalence criteria for all three measures of patient satisfaction: pain relief, mean -0.2, 95% CI -0.53 to 0.68; ability to walk and bend, mean -0.2, 95% CI -0.54 to 0.64; willingness to continue medication, mean -0.7, 95% CI -0.98 to 0.49. The 95% CIs for the q.d. vs b.i.d. comparison were also within the -2 to +2 interval.

Conclusion. Regardless of the time of day at which celecoxib 200 mg q.d. is administered, patients are equally satisfied with the pain relief, ability to walk and bend, and willingness to continue medication.

Key words: Osteoarthritis, COX-2 specific inhibitor, Celecoxib, Dose regimen.
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