[en] Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Cyclooxygenase Inhibitors/therapeutic use ; Diclofenac/adverse effects/therapeutic use ; Double-Blind Method ; Female ; Humans ; Lumbar Vertebrae ; Male ; Middle Aged ; Osteoarthritis/drug therapy ; Spinal Diseases/drug therapy ; Thiazines/adverse effects/therapeutic use ; Thiazoles/adverse effects/therapeutic use
[en] OBJECTIVE: The aim of this study was to evaluate the efficacy and tolerability of meloxicam compared with diclofenac in patients with osteoarthritis of the lumbar spine. SUBJECTS: 229 patients with radiologically confirmed osteoarthritis of the lumbar spine. TREATMENT AND METHODS: Once-daily meloxicam 7.5 mg tablet or diclofenac 100 mg slow release tablet. Efficacy and tolerability parameters were assessed at baseline and after 3, 7 and 14 days of treatment. RESULTS: The two drugs had equal short-term efficacy, with pain on motion of lumbar spine significantly (p<0.05) decreased at Day 3. Secondary efficacy variables were also significantly improved at Days 3, 7 and 14. There were no statistically significant differences between the two drugs, although the global tolerability of meloxicam was significantly better than for diclofenac, as assessed by the investigators (p = 0.0072) and the patients (p = 0.049). CONCLUSIONS: Meloxicam and diclofenac were equivalent in relieving the acute pain associated with osteoarthritis of the lumbar spine. However, meloxicam was much better tolerated.