Objectives: To assess the efficacy and safety of etoricoxib 60 mg once daily and naproxen 500 mg twice daily over a 138-week treatment period in patients with osteoarthritis (OA).
Methods: Two 1-year randomized, double-blind, parallel-group 2-part base studies (Part I 12 weeks; Part II 40 weeks), followed by an 86-week extension, in OA (hip or knee) patients were conducted at 80 clinical centers (19 countries). The studies had identical designs. Patients taking placebo in Part I received etoricoxib or naproxen (1:1 ratio) in Part II and the Extension; patients taking etoricoxib or naproxen in Part I remained on the same treatment throughout the entire length of the studies. Co-primary efficacy endpoints were Patient Global Assessment of Disease Status, and WOMAC questionnaire Pain Subscale and Physical Function Subscale (100mm VAS). Efficacy over 138-weeks was assessed by graphical analysis. Safety was assessed by observation of adverse experiences and laboratory and physical evaluations.
Results: There were 997 patients who entered (615 completed) the Base studies. Of these patients, 463 patients entered the Extensions. A total of 161 and 151 patients in the etoricoxib and naproxen groups, respectively, completed 138-treatment weeks. Etoricoxib and naproxen showed similar efficacy throughout the 138 weeks of therapy. For etoricoxib and naproxen, respectively, WOMAC Pain assessments were: 67 and 67 mm (baseline); 28 and 29 mm (1-year), and 34 and 33mm (138- weeks). Results for the other efficacy endpoints were similar to those seen with the WOMAC Pain assessments. Both etoricoxib and naproxen were generally well tolerated.
Conclusion: Both etoricoxib and naproxen demonstrated long-term clinical efficacy for the treatment of OA. Etoricoxib and naproxen were generally well tolerated.
- COX-2 selective inhibitors