A LONG-TERM STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MELOXICAM THERAPY IN PATIENTS WITH RHEUMATOID-ARTHRITIS

Meloxicam is a new non-steroidal anti-inflammatory drug (NSAID), which has a higher activity against cyclooxygenase-2 (COX-2) than against c yclooxygenase-1 (COX-1), with potentially high anti-inflammatory and a nalgesic action. This study was designed to assess the long-term safet y and efficacy of meloxicam 15 mg daily. Three hundred and fifty-seven patients (aged 19-84 yr, mean 56 yr) with rheumatoid arthritis (RA) r eceived meloxicam 15 mg orally once daily, for up to 18 months. Sixty- six per cent of patients remained on therapy for 18 months. Mean globa l efficacy, assessed by each patient on a visual analogue scale (0 cm excellent, 10 cm = useless), was 3.32 +/- 3.1 cm at the last study vis it (all patients included) and 2.33 +/- 2.25 cm after 18 months. Healt h status, general condition, morning stiffness, grip strength of right hand, Ritchie joint index, pain in the morning and pain at night all improved significantly. Efficacy was maintained throughout the study. Only 11.4% of patients discontinued prematurely due to lack of efficac y. Mean global tolerance was good. Twenty-eight per cent of patients e xperienced gastrointestinal (GI) adverse events, 21% musculoskeletal s ystem disorders, 18% skin disorders and 15% respiratory disorders. Onl y 13.7% of patients discontinued due to adverse events. Severe GI effe cts, such as perforation, ulcer and bleeding, occurred in only three p atients (0.8%). Withdrawals due to GI adverse events occurred in 3.9% of patients. Meloxicam 15 mg once daily was effective and compared fav ourably with standard NSAIDs regarding tolerance when administered to patients with RA over an 18 month period.