A 6-MONTH DOUBLE-BLIND TRIAL TO COMPARE THE EFFICACY AND SAFETY OF MELOXICAM 7.5 MG DAILY AND NAPROXEN 750 MG DAILY IN PATIENTS WITH RHEUMATOID-ARTHRITIS

Meloxicam is a new non-steroidal anti-inflammatory drug (NSAID) which preferentially inhibits cyclooxygenase-2 over cyclooxygenase-1. A doub le-blind, parallel-group trial compared meloxicam 7.5 mg once daily (n = 199) with naproxen 750 mg (n = 180) in rheumatoid arthritis. There was no significant difference between the groups regarding the primary efficacy variables (global efficacy assessment by patient and investi gator, number of painful/tender and swollen joints) and eight of the t en secondary efficacy endpoints. Only the swollen joint severity index and the number of discontinuations due to lack of efficacy favoured n aproxen 750 mg significantly over meloxicam 7.5 mg. Meloxicam was bett er tolerated in the gastrointestinal (GI) tract, with fewer GI adverse events in the meloxicam-treated group (30.3%) than in the naproxen-tr eated group (44.7%), where two patients developed ulcers. No ulcers we re seen in meloxicam patients. Significantly more patients discontinue d due to GI adverse events in the naproxen group. Additionally, there was a significant decrease in haemoglobin and a significant increase i n serum creatinine and urea in the naproxen group compared with the me loxicam group. In conclusion, meloxicam 7.5 mg once daily is a promisi ng treatment in rheumatoid arthritis, with efficacy comparable to napr oxen 750 mg. Meloxicam has the advantage of a significantly lower inci dence of GI and renal side effects.