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Ann Rheum Dis. 2004 November; 63(11): 1419–1426.
Published online 2004 February 27. doi:  10.1136/ard.2003.015974
PMCID: PMC1754793

Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a 13 week, randomised, double blind study versus placebo and celecoxib

Abstract

Objectives: To compare the efficacy and safety of lumiracoxib with placebo and celecoxib for osteoarthritis OA in a 13 week, multicentre, randomised, double blind study.

Methods: After a 37 day washout period for nonsteroidal antiinflammatory drugs, 1702 patients with knee OA were randomised to lumiracoxib 200 or 400mg once daily od, celecoxib 200mg od, or placebo 2221. A visual analogue scale VAS pain intensity 40mm was required. Primary efficacy variables were OA pain intensity VAS mm in the target knee, patients global assessment of disease activity VAS mm, and WOMAC pain subscale and total scores at 13weeks. OA pain intensity, patients and physicians global assessment of disease activity, and WOMAC total and all subscale scores were analysed by visit as secondary variables.

Results: Lumiracoxib showed significant improvements in all primary and secondary variables compared with placebo. Lumiracoxib 200mg od and celecoxib 200mg od achieved similar improvements in OA pain intensity and functional status. Lumiracoxib 400mg od demonstrated better efficacy for OA pain intensity and patients global assessment of disease activity at weeks 2, 4, and 8 and similar efficacy at week 13 compared with celecoxib 200mg od. The incidence of adverse events AEs, serious AEs, and discontinuations due to AEs was similar in each group.

Conclusion: Lumiracoxib demonstrated significant improvement in OA pain intensity, patients global assessment of disease activity, and the WOMAC pain subscale and total scores compared with placebo. Lumiracoxib was well tolerated in this study, with overall tolerability similar to that of placebo and celecoxib.

Figure 1
Patient flow diagram. Other includes protocol violation, withdrawal of consent, and condition no longer requiring the study drug.
Figure 2
Osteoarthritis pain intensity VAS mm in the target knee at weeks 2, 4, 8, and 13 with lumiracoxib 200mg and 400mg od, celecoxib 200mg od, and placebo. Values are least square means, except for baseline, which are means. p0.001 all active treatment groups ...
Figure 3
Patients global assessment of disease activity VAS mm at weeks 2, 4, 8, and 13 with lumiracoxib 200mg and 400mg od, celecoxib 200mg od, and placebo. Values are least square means, except for baseline, which are means. p0.001 all active treatment groups ...
Figure 4
Mean SEM change from baseline in WOMAC pain subscale A and total B scores at week 13 with lumiracoxib 200mg and 400mg od, celecoxib 200mg od, and placebo. Statistical analyses performed using least square means. p0.01 v placebo p0.001 v placebo.

Articles from Annals of the Rheumatic Diseases are provided here courtesy of BMJ Group