A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF EFFICACY AND TOLERANCE OF MELOXICAM TREATMENT IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE

Meloxicam is a new non-steroidal anti-inflammatory drug (NSAID), with a favourable ratio of inhibition of cyclooxygenase-2 (COX-2)/cyclooxyg enase-1 (COX-1), giving the drug the potential to produce few gastric adverse effects. The aim of this study was to investigate the efficacy and safety of meloxicam in patients with osteoarthritis (OA) of the k nee. Five hundred and thirteen patients were treated in a double-blind trial comparing once-daily meloxicam 7.5 mg, 15 mg, 30 mg, or placebo (140, 134, 102 and 137 patients, respectively). Outcome measures incl uded scores on Visual Analogue Scales (VAS) for pain on movement (prim ary endpoint) and pain at rest in the target joint as well as global e fficacy. Lesquesne's index of severity and paracetamol consumption wer e also measured. Global tolerability and the occurrence of adverse eve nts were monitored. Both meloxicam 7.5 mg and 15 mg were significantly more effective than placebo with respect to pain on movement (p < 0.0 1 and p < 0.03, respectively). Both doses of meloxicam compared favour ably with placebo with respect to pain of the target joint at rest, al though only the 15 mg dose achieved statistical significance (p < 0.02 ). Global efficacy showed a significant difference for both doses of m eloxicam (p < O.O5 and p < 0.002 for 7.5 mg and 15 mg doses, respectiv ely). Once daily meloxicam 7.5 and 15 mg is effective and well tolerat ed in the short term symptomatic treatment of OA of the knee.