[en] 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 parameter (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.
Disciplines :
General & internal medicine
Author, co-author :
REGINSTER, Jean-Yves ; Centre Hospitalier Universitaire de Liège - CHU > Médecine de l'appareil locomoteur
Distel, M.
Bluhmki, E.
Language :
English
Title :
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.
Vane JR. Inhibition of prostaglandin synthesis as a mechanism of action for aspirin-like drugs. Nature New Biol 1971;231:232-5.
Vane J. Towards a better aspirin. Nature 1994;367:215-6.
Engelhardt G, Homma D, Schlegel K, Utzmann R, Schnitzler C. Anti-inflammatory, analgesic, antipyretic and related properties of meloxicam, a new non-steroidal anti-inflammatory agent with favourable gastrointestinal tolerance. Inflamm Res 1995;44:423-33.
Engelhardt G. Meloxicam: a potent inhibitor of COX-2. Data presented at 9th International Conference on Prostaglandins and Related Compounds. Florence, Italy, June 6-10,1994, p. 82.
Huskisson EC, Narjes H, Bluhmki E. Efficacy and tolerance of meloxicam, a new NSAID, in daily oral doses of 15, 30 and 60 mg in comparison to 20 mg piroxicam in patients with rheumatoid arthritis. Scand J Rheumatol 1994;Suppl 98:abstractno. 115.
Ritchie DM, Boyle JA, McInness JM et al. Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis. Q J Med 1968;37:393-406.
Furst DE. Synovial fluid kinetics of non-steroidal anti-inflammatory drugs: basis for variability in response. Agents Actions 1985;Suppl 17:65-78.
Larkai EN, Lacey Smith J, Lidsky MD, Sessoms SL, Graham DY Dyspepsia in NSAID users: the size of the problem. J Clin Gastroenterol 1989;11:158-62.
Coles LS, Fries JF, Kraines RG, Roth SH. From experiment to experience: side effects of nonsteroidal anti-inflammatory drugs. Am J Med 1983;74:820-8.
Lemmel EM, Bolten W, Burgos-Vargas R et al. A double-blind placebo controlled study of 7.5 mg and 15 mg of meloxicam in patients with rheumatoid arthritis (RA). Scand J Rheumatol 1994;Suppl 98:abstract no. 111.
Lund B, Distel M, Bluhmki E. A double-blind placebo controlled study of three different doses of meloxicam in patients with osteoarthritis (OA) of the knee. Scand J Rheumatol 1994;Suppl 98:abstract no. 117.
Lequesne M. Methodology issues in the evaluation of NSAID in inflammatory rheumatic diseases. J Rheumatol 1990;17(suppl. 20):25-8.
Gøtzsche PC. Sensitivity of effect variables in rheumatoid arthritis: a meta-analysis of 130 placebo controlled NSAID trials. J Clin Epidemiol 1990;43:1313-8.