Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial

Ana C Gordo, Chris Walker, Beatriz Armada, Duo Zhou, Ana C Gordo, Chris Walker, Beatriz Armada, Duo Zhou

Abstract

Objective To compare the efficacy and tolerability of celecoxib and ibuprofen for the treatment of knee osteoarthritis symptoms. Method In this 6-week, multicentre, double-blind, non-inferiority trial, patients were randomized to 200 mg celecoxib once daily, 800 mg ibuprofen three times daily or placebo. The primary outcome was non-inferiority of celecoxib to ibuprofen in Patient's Assessment of Arthritis Pain (scored 0-100). Secondary outcomes included the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, Pain Satisfaction Scale, and upper gastrointestinal tolerability. Results A total of 388 patients were treated (celecoxib n = 153; ibuprofen n = 156; placebo n = 79). Mean difference (95% confidence interval) between celecoxib and ibuprofen in the Patient's Assessment of Arthritis Pain was 2.76 (-3.38, 8.90). As the lower bound was greater than -10, celecoxib was non-inferior to ibuprofen. The WOMAC total score was significantly improved with celecoxib and ibuprofen, versus placebo. Patients receiving celecoxib were significantly more satisfied (versus placebo) in 10 of 11 measures on the Pain Satisfaction Scale versus three measures with ibuprofen. Upper gastrointestinal events were less frequent with celecoxib (1.3%) than ibuprofen (5.1%) or placebo (2.5%). Conclusion Celecoxib was well tolerated and as effective as ibuprofen for symptoms associated with knee osteoarthritis. ClinicalTrials.gov identifier NCT00630929.

Keywords: COX-2 inhibitors; celecoxib; cyclooxygenase; non-steroidal anti-inflammatory drugs; osteoarthritis.

Figures

Figure 1.
Figure 1.
Flow diagram showing patient numbers in a 6-week, multicentre, randomized, double-blind, placebo-controlled, active comparator, parallel-group study to assess the efficacy of 200 mg celecoxib once daily compared with 800 mg ibuprofen three times daily in patients with osteoarthritis of the knee. MITT, modified intent-to-treat; PPA, per-protocol analysis; QD, once daily; TID, three times daily.
Figure 2.
Figure 2.
(a) Physician’s Global Assessment of Arthritis at week 6 (MITT). *P = 0.0027 versus placebo group. (b) LS mean change in WOMAC scores at week 6 (MITT). *P ≤ 0.03 versus placebo group; **P = 0.0220 versus ibuprofen group, for mean change in WOMAC scores. LS, least squares; MITT, modified intent-to-treat; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index. The colour version of this figure is available at: http://imr.sagepub.com.

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