Etoricoxib in the treatment of Korean patients with osteoarthritis in a double-blind, randomized controlled trial

Abstract

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 (100 mm Visual Analog Scale [VAS]; primary endpoint), the WOMAC VA 3.0 Physical Function Subscale (100 mm VAS), and Patient Global Assessment of Disease Status (PGAD) (100 mm 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 10 mm 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), −1.32 mm (−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.

Keywords::

• Celecoxib
• COX-2 inhibitor
• Etoricoxib
• Korean patients
• NSAIDs
• Osteoarthritis

Transparency

Declaration of funding

This study was funded by Merck & Co. Inc., Whitehouse Station, NJ, USA.

Author contributions: M.C.Y. conceived and designed the study collected data, supervised analyses, interpreted results, critically reviewed, and provided substantive suggestions on the manuscript. W.H.Y. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. S.B.K. conceived and designed the study collected data, supervised analyses, interpreted results, critically reviewed, and provided substantive suggestions on the manuscript. Y.-W.P. collected or assembled data, supervised analyses, critically reviewed the manuscript, and provided substantive suggestions. SSK collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. K.H.M. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. Y.W.S. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. B.W.M. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. Y.J.C. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. S.-H.M. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. S.-I.B. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. H.-J.B. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. S.C.S. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. S.W.L. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. D.H.Y. collected or assembled data, critically reviewed the manuscript, and provided substantive suggestions. A.M.:interpreted results, wrote sections of the initial manuscript draft, critically reviewed the manuscript, and provided substantive suggestions. A.S. performed analyses, interpreted the results, critically reviewed the manuscript, and provided substantive suggestions. D.M.C. performed analyses, interpreted the results, critically reviewed the manuscript, and provided substantive suggestions. K.V. performed analyses, interpreted the results, critically reviewed the manuscript, and provided substantive suggestions. L.Y. conceived the study, assembled data, supervised analyses, interpreted results, wrote sections of the initial draft, critically reviewed the manuscript, and provided substantive suggestions. All authors read and approved the final manuscript.

Declaration of financial/other relationships

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.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgments

This study was previously presented at the Asia Pacific League of Associations for Rheumatology (APLAR) meeting in April 2014.

The authors take full responsibility for the content of the paper. The authors thank Sheila Erespe (Merck & Co. Inc., Whitehouse Station, NJ, USA) for editorial and administrative assistance and Ji Young Park (MSD Korea, Seoul, Republic of Korea) for logistic and administrative support.