Evaluation of the efficacy and safety of etoricoxib in the treatment of hemophilic arthropathy.
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 (> or = 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.
Tsoukas
Christos
C
McGill University Health Centre, Montreal General Hospital, 1650 Cedar Ave, Rm A5-140, Montreal, QC H3G 1A4, Canada. chris.tsoukas@muhc.mcgill.ca
Eyster
M Elaine
ME
Shingo
Sumiko
S
Mukhopadhyay
Saurabh
S
Giallella
Karen M
KM
Curtis
Sean P
SP
Reicin
Alise S
AS
Melian
Agustin
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D000077613:Etoricoxib; D005260:Female; D006261:Headache / Q000209:etiology; D006395:Hemarthrosis / Q000150:complications / Q000188:drug therapy* / Q000201:enzymology; D006467:Hemophilia A / Q000150:complications / Q000201:enzymology; D006801:Humans; D007783:Lactones / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008565:Membrane Proteins / Q000037:antagonists & inhibitors; D008875:Middle Aged; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D012141:Respiratory Tract Infections / Q000209:etiology; D013450:Sulfones / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D052246:Cyclooxygenase 2 Inhibitors; D007783:Lactones; D008565:Membrane Proteins; D011725:Pyridines; D013450:Sulfones; C116926:rofecoxib; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D000077613:Etoricoxib