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


CONCLUSIONS
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.
Stengaard-Pedersen
K
K
Department of Rheumatology, Aarhus University Hospital, Denmark. stengaard@akh.aaa.dk
Ekesbo
R
R
Karvonen
A-L
AL
Lyster
M
M
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000188:drug therapy*; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D017060:Patient Satisfaction; D011720:Pyrazoles; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib