Etoricoxib versus naproxen in patients with rheumatoid arthritis: a prospective, randomized, comparator- controlled 121-week trial

ABSTRACTBackground: Etoricoxib is a cyclooxygenase-2 (COX‑2) selective inhibitor effective in the treatment of rheumatoid arthritis. An initial 12-week treatment study found that etoricoxib (90 mg once daily) was more effective than naproxen (500 mg twice daily) or placebo in treating rheumatoid arthritis. The present two-part extension of that study was performed to monitor tolerability and examine long-term efficacy of etoricoxib 90 mg or 120 mg compared with naproxen.Methods: Patients completing the initial 12-week study and those discontinuing due to lack of efficacy, were eligible for the Extension Study Part I (12–52 weeks) and assigned (2 : 1 : 2 ratio) to receive etoricoxib (90 mg or 120 mg daily) or naproxen (500 mg twice daily); these patients remained on the same therapy for Extension Study Part II (52–121 weeks). Primary outcome measures included investigator and patient assessment of disease activity, and tender and swollen joint counts.Results: Of 816 patients enrolled in the initial 12-week...