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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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Submitted September 9, 2004
Accepted October 3, 2005
Evaluation of the efficacy and safety of etoricoxib in the treatment of hemophilic arthropathy
Christos Tsoukas*, M E Eyster, Sumiko Shingo, Saurabh Mukhopadhyay, Karen M Giallella, Sean P Curtis, Alise S Reicin, and Agustin Melian
McGill Univesity Health Centre, Montreal, Quebec, Canada
Penn State Hershey Medical Center, Hershey, PA, USA
Merck Research Laboratories, Rahway, NJ, USA
* Corresponding author; email: chris.tsoukas{at}muhc.mcgill.ca.
This two-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-I (6 weeks), 102 hemophilic arthropathy patients ( 12 years old) were randomized to etoricoxib 90mg once-daily or placebo (1:1 ratio). In Part-II (6 months), 51 patients taking placebo in Part-I were randomized to receive etoricoxib 90mg or rofecoxib 25mg* once-daily; etoricoxib patients in Part-I continued the same treatment. Efficacy endpoints 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 endpoints versus placebo (p< 0.001). Fewer etoricoxib patients discontinued due to a lack of efficacy versus placebo (p=0.048). During Part-II, 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-I was similar between etoricoxib (66.7%) and placebo (72.6%) and during Part-II 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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