Rheumatology Advance Access originally published online on August 27, 2006
Rheumatology 2007 46(3):496-507; doi:10.1093/rheumatology/kel296
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Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies
Johns Hopkins University, Baltimore, MD, 1Arthritis Associates, Palm Harbor, FL, 2University of North Texas, Fort Worth, TX, 3Westside Family Medical Centre, Kalamazoo, MI, 4The Centre for Rheumatology, Albany, NY and 5Merck & Co., Inc., West Point, PA, USA.
Correspondence to: Clifton O. Bingham III, MD, 5200 Eastern Avenue, Mason F. Lord Building, Centre Tower, Room 404, Baltimore, MD 21224, USA. Email: Clifton.bingham{at}jhmi.edu
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Abstract |
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Objective. To compare the efficacy of etoricoxib 30 mg with the generally maximum recommended dose of celecoxib, 200 mg, in the treatment of osteoarthritis (OA) in two identically designed studies.
Methods. Two multi-centre, 26-week, double-blind, placebo-controlled, non-inferiority studies were conducted, enrolling patients who were prior non-steroidal anti-inflammatory drug (NSAID) or acetaminophen users. There were 599 patients in study 1 and 608 patients in study 2 randomized 4:4:1:1 to etoricoxib 30 mg qd, celecoxib 200 mg qd or one of two placebo groups for 12 weeks. After 12 weeks, placebo patients were evenly distributed to etoricoxib or celecoxib based on their initial enrollment randomization schedule. The primary hypothesis was that etoricoxib 30 mg would be at least as effective as celecoxib 200 mg for the time-weighted average change from baseline over 12 weeks for Western Ontario and McMaster (WOMAC) Pain Subscale, WOMAC Physical Function Subscale and Patient Global Assessment of Disease Status. Active treatments were also assessed over the full 26 weeks. Adverse experiences were collected for safety assessment.
Results. In both studies, etoricoxib was non-inferior to celecoxib for all three efficacy outcomes over 12 and 26 weeks; both were superior to placebo (P < 0.001) for all three outcomes in each study over 12 weeks. The safety and tolerability of etoricoxib 30 mg qd and celecoxib 200 mg qd were similar over 12 and 26 weeks.
Conclusions. Etoricoxib 30 mg qd was at least as effective as celecoxib 200 mg qd and had similar safety in the treatment of knee and hip OA; both were superior to placebo.
ClinicalTrials.gov Identifiers: NCT00092768 [ClinicalTrials.gov] ; NCT00092791
KEY WORDS: Celecoxib, COX-2 inhibitor, Efficacy, Etoricoxib, Osteoarthritis, WOMAC
Submitted 19 January 2006;
revised version accepted 9 June 2006.
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