Long-term efficacy and safety of lumiracoxib 100 mg: an open-label extension of a 13-week randomized controlled trial in patients with primary osteoarthritis of the knee.

OBJECTIVE Osteoarthritis (OA) is a chronic condition, accompanied by inflammation and pain, and it is therefore important to demonstrate long-term efficacy and safety of treatment. Here we present data from a 39-week open-label extension to a 13-week randomized, double-blind, double-dummy, parallel-group core study. The objective was to assess the long-term safety and tolerability of lumiracoxib 100 mg once daily (od). METHODS Patients had originally received lumiracoxib 100 mg od, celecoxib 200 mg od or placebo in the core study. In the extension period, all patients received lumiracoxib 100 mg od. Efficacy variables, overall OA pain intensity (0-100 mm visual analogue scale [VAS]), patient's global assessment of disease activity and physician's global assessment of disease activity (0-100 mm VAS), were assessed at weeks 17, 26, 39 and 52. General safety and tolerability were evaluated by adverse event (AE) reporting and physical examinations and laboratory tests at each visit. RESULTS Of the 1182 patients completing the core study, 834 patients entered the extension study. Improvements in the three efficacy variables after 3 months were maintained for up to 1 year with lumiracoxib treatment. Lumiracoxib was well tolerated, with most AEs being of mild-to-moderate severity and of the type expected for this patient population and duration of exposure. CONCLUSION In conclusion, these data suggest that lumiracoxib 100 mg od was effective and well tolerated when treating OA pain of the knee for periods of up to 1 year, making it a useful option for the long-term treatment of OA pain.