Objective: We evaluated the COX-2 inhibitors, etoricoxib and celecoxib, in Korean patients with osteoarthritis (OA).
Methods: This study included patients (≥40 years of age) with a clinical and radiographic diagnosis of knee OA. Patients were randomized to etoricoxib 30 mg (qd) or celecoxib 200 mg (qd) in a 12 week randomized, controlled, double-blind study. Prior NSAID users were to demonstrate a worsening of symptoms upon withdrawal of medication. Efficacy endpoints included the time-weighted average change from baseline in the WOMAC VA 3.0 Pain Subscale (100mm Visual Analog Scale [VAS]; primary endpoint), the WOMAC VA 3.0 Physical Function Subscale (100mm VAS), and Patient Global Assessment of Disease Status (PGAD) (100mm VAS). The primary hypothesis was that etoricoxib 30 mg is non-inferior to celecoxib 200 mg as assessed by the primary endpoint (the non-inferiority margin was set at 10mm VAS). Adverse events (AEs), laboratory parameters, and vital signs were monitored.
Results: There were 239 patients (89.5% female; mean age: 63.3 years) randomized to etoricoxib 30 mg (n=120) and celecoxib 200 mg (n=119). The differences (etoricoxib vs celecoxib) in least square (LS) mean change (95% CI) for WOMAC Pain, WOMAC Physical Function, and PGAD were -1.63 mm (-5.37, 2.10), -1.32mm (-4.88, 2.23), and -1.09 mm (-5.48, 3.30), respectively. Drug-related clinical AEs occurred in 6.7% (etoricoxib) and 2.5% (celecoxib) of patients. This study was limited because it was not designed or powered to adequately capture and evaluate rare AEs associated with NSAID treatment.
Conclusions: Etoricoxib 30 mg administered once daily in Korean patients with knee OA demonstrated non-inferior clinical efficacy to celecoxib 200 mg over 12 weeks of treatment as assessed by all primary and secondary outcomes. Etoricoxib 30 mg qd and celecoxib 200 mg qd were generally safe and well tolerated.
Clinical trial registration: NCT01554163.
Bibliographical noteFunding Information:
This study was funded by Merck & Co. Inc., Whitehouse Station, NJ, USA.
A.M., A.S., D.M.C., K.V., and L.Y. have disclosed that they are current or former employees of Merck & Co. Inc., the sponsor of this study. Y.J.C. has disclosed that she/he has received research grants from MSD Korea. D.H.Y. has disclosed that she/he has received research grants and consulting and speakers’ fees from Celltrion. M.C.Y., W.H.Y., S.B.K., Y.-W.P., S.S.K., K.H.M., Y.W.S., B.W.M., S.-H.M., S.-I.B., H.-J.B., S.C.S., and S.W.L. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.
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