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Blood, 1 March 2006, Vol. 107, No. 5, pp. 1785-1790.
Prepublished online as a Blood First Edition Paper on November 15, 2005; DOI 10.1182/blood-2004-09-3501.


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CLINICAL TRIALS AND OBSERVATIONS

Evaluation of the efficacy and safety of etoricoxib in the treatment of hemophilic arthropathy

Christos Tsoukas, M. Elaine Eyster, Sumiko Shingo, Saurabh Mukhopadhyay, Karen M. Giallella, Sean P. Curtis, Alise S. Reicin, and Agustin Melian

From the McGill University Health Centre, Montreal, QC, Canada; Penn State Hershey Medical Center, Hershey, PA; and Merck Research Laboratories, Rahway, NJ.

This 2-part, double-blind, placebo-controlled study was conducted to determine the safety and efficacy of etoricoxib, a COX-2 selective inhibitor, for the treatment of hemophilic arthropathy. In part 1 (6 weeks), 102 patients (≥ 12 years old) with hemophilic arthropathy were randomized to receive 90 mg etoricoxib once daily or placebo (1:1 ratio). In part 2 (6 months), 51 patients taking placebo in part 1 were randomized to receive 90 mg etoricoxib or 25 mg rofecoxib once daily; patients taking etoricoxib in part 1 continued the same treatment. Efficacy end points included Patient Assessment of Arthropathy Pain, Patient Global Assessment of Arthropathy Disease Status, and Investigator Global Assessment of Arthropathy Disease Status. Safety was evaluated at each study visit. Etoricoxib provided significant improvement in all end points versus placebo (P < .001). Fewer patients taking etoricoxib discontinued due to a lack of efficacy versus placebo (P = .048). During part 2, efficacy was maintained; etoricoxib and rofecoxib demonstrated similar results. The most common adverse experiences were upper respiratory infection and headache. The incidence of joint bleeding during part 1 was similar between etoricoxib (66.7%) and placebo (72.6%) and during part 2 between etoricoxib (77.0%) and rofecoxib (78.9%). We conclude that etoricoxib provided superior efficacy versus placebo for the treatment of hemophilic arthropathy and was generally safe and well tolerated.


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J. Zhang, E. L. Ding, and Y. Song
Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials
JAMA, October 4, 2006; 296(13): 1619 - 1632.
[Abstract] [Full Text] [PDF]



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