The clinical study of etoricoxib in the treatment of Chinese patients with osteoarthritis / 中华风湿病学杂志

ABSTRACT

Objective To compare the clinical response with etoricoxib 60 mg once daily with diclofenac sodium tablet 75 mg two times daily in the treatment of osteoarthritis of the knee or hip joint.Methods A 4-week multicenter,randomized,double-blinded and active comparator-controlled clinical trial was performed during January 2005 and June 2005 in 6 medical centers in China.Eligible patients (≥40 years old Chinese patients with osteoarthritis of the knee and hip) were randomized (11 ratio) to receive etoricoxib 60 mg once daily (n=90),or diclofenac sodium 75 mg twice daily (n=90).Primary efficacy end point is the change of WOMAC (Western Ontario and McMaster Universities osteoarthritis index) pain subscale from baseline to 4 weeks; non-inferiority bounds were pre-defined [if the upper bound of 95％ confidence interval (CI) for the difference is less than 10 mm on a 100-mm VAS WOMAC pain subscale] for the comparison of the change between the two groups.The secondary efficacy endpoints include WOMAC physical function subscale,WOMAC stiffness subscale,patient's global assessment of response to therapy (PGART),investigator's global assessment of disease status (IGADS),discontinuation due to lack of efficacy and rescue paracetamol tablet count.Safety was assessed by physical examination,adverse experience reported,and laboratory safety data.Results C6mpared to baseline,the changes of WOMAC pain subscale after 4 weeks treatment were statistically significant (P＜0.01) in both groups (etoricoxib group51±16 vs 21± 19; diclofenac sodium group53±16 vs 22±19).There was no difference in the change of WOMAC pain subscale between the two groups.The change in WOMAC stiffness subscale,WOMAC physical function subscale,PGART and IGADS in both groups were statistically significant (P＜0.01),but there was no difference between treatment groups according to the pre-defined non-inferiority criteria.No drug related serious adverse events were observed during the study.The difference in drug-related adverse event incidence between the two groups was not statistically significant.Etoricoxib and diclofenac sodium were generally safe and well tolerated.Conclusion Etoricoxib 60 mg administered once daily is efficacious and shows clinical efficacy notinferior to that of diclofenac sodium 75 mg administered twice daily for the treatment of osteoarthritis.Etoricoxib 60 mg administered once daily for 4 weeks is generally safe and well tolerated.