Abstract

Aims: To evaluate the efficacy and safety of celecoxib in patients with osteoarthritis who previously failed naproxen and ibuprofen treatment. Materials & methods: Two identical, 6-week, randomized, double-blind, placebo-controlled trials of celecoxib 200 mg daily were undertaken in patients with knee osteoarthritis. The primary efficacy variable was the 6-week change in Patient's Assessment of Arthritis Pain visual analog scale. Results: In study 1 (n = 370), the visual analog scale least squares mean decrease from baseline was 27.3 (celecoxib) versus 14.9 mm (placebo; p < 0.001); it was 28.0 versus 24.6 mm, respectively, in study 2 (n = 380). Conclusion: Celecoxib was well tolerated, yet the efficacy results differed, highlighting the complexities of treating patients with osteoarthritis who have failed previous NSAID treatment.

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