PT  - JOURNAL ARTICLE
AU  - J-P Raynauld
AU  - J Martel-Pelletier
AU  - P Bias
AU  - S Laufer
AU  - B Haraoui
AU  - D Choquette
AU  - A D Beaulieu
AU  - F Abram
AU  - M Dorais
AU  - É Vignon
AU  - J-P Pelletier
AU  - and the Canadian Licofelone Study Group
TI  - Protective effects of licofelone, a 5-lipoxygenase and cyclo-oxygenase inhibitor, versus naproxen on cartilage loss in knee osteoarthritis: a first multicentre clinical trial using quantitative MRI
AID  - 10.1136/ard.2008.088732
DP  - 2009 Jun 01
TA  - Annals of the Rheumatic Diseases
PG  - 938--947
VI  - 68
IP  - 6
4099  - http://ard.bmj.com/content/68/6/938.short
4100  - http://ard.bmj.com/content/68/6/938.full
SO  - Ann Rheum Dis2009 Jun 01; 68
AB  - Objective: In a multicentre study to explore the effects of licofelone as a disease-modifying osteoarthritis drug in comparison with naproxen in patients with knee osteoarthritis (OA), using MRI and x-ray examination.Methods: Patients with knee OA (n = 355) were randomised to receive either licofelone (200 mg twice a day) or naproxen (500 mg twice a day). MRI and x-ray examinations were performed at baseline, 6 months (MRI only), 12 and 24 months. MRI was used to assess quantitatively changes in cartilage volume, and x-ray examinations (Lyon–Schuss) to measure changes in the mean and minimum joint space width (JSW) in the medial compartment. Questionnaires probing symptoms were completed. Data were presented as intention to treat (ITT) and according to protocol (ATP).Results: Cartilage volume loss in the global joint and medial and lateral compartments was significantly less in the licofelone than in the naproxen group for ITT at 12 and 24 months and for ATP at all times except in the medial compartment. Patients with medial meniscal extrusion had a greater loss of cartilage volume. In these patients, licofelone markedly reduced the cartilage loss for both ITT and ATP at 12 and 24 months. Although licofelone showed less reduction in the JSW than naproxen, this did not reach significance. All clinical variables were improved at 24 months (p<0.001) for both groups, with a good safety profile.Conclusion: Licofelone and naproxen were equally effective in reducing OA symptoms; however, licofelone significantly reduced cartilage volume loss over time, thus having a protective effect in patients with knee OA. This study proves the superiority of quantitative MRI over x-ray examinations in a multicentre clinical trial.