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© 1996 British Society for Rheumatology

A Double-Blind, Three-Week Study to Compare the Efficacy and Safety of Meloxicam 7.5 mg and Meloxicam 15 mg in Patients with Rheumatoid Arthritis

J. Y. Reginster*, M. Distel{dagger} and E. Bluhmki{ddagger}

* Bone and Cartilage Metabolism Research Unit, University of Liège Belgium Georgetown University Medical Centre Washington DC, USA
{dagger} Departments of Clinical Research, Birkendorfer Straβe65 88397, Biberachl Riss, Germany
{ddagger} Departments of Biostatistics, Boehringer Ingelheim Gmb, Birkendorfer Straβe65, 88397 Biberachl Riss, Germany

Correspondence to: Correspondence to: J. Y. Reginster, University of Liège, CHU Centre Ville, 45 Quai 6 Kurth, 4020 Liège, Belgium.


  Abstract

A multicentre, double-blind, randomized study was conducted in patients with rheumatoid arthritis (RA) in order to compare the efficacy and safety of two different doses of meloxicam, a new preferential cyclooxygenase-2 (COX-2) inhibitor. Four hundred and twenty-three patients were randomized to receive once-daily oral meloxicam 7.5 mg (n = 216) or meloxicam 15 mg (n = 207) for 3 weeks. The Ritchie joint index and pain in the morning were significantly improved versus baseline (P < 0.001) in both groups. There were no significant differences between the effects of each dose with respect to these measures nor with respect to final assessment of global efficacy by the patients. However, the 15 mg dose was associated with a significantly (P < 0.05) better effect on morning stiffness and grip strength. No differences between the doses were observed with regard to the other secondary efficacy parameters (pain at night, body weight and erythrocyte sedimentation rate). Both doses of meloxicam were well tolerated. There were no differences between the doses with respect to global tolerance as assessed by the patient and the patients, ‘general condition’. In conclusion, meloxicam at a once-daily dose of either 7.5 or 15 mg is well tolerated and effective in the treatment of patients with RA.

KEY WORDS: Rheumatoid arthritis, Non-steroidal anti-inflammatory drugs, Meloxicam, COX-2 inhibition


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