THE EFFICACY AND TOLERABILITY OF AN 8-DAY ADMINISTRATION OF INTRAVENOUS AND ORAL MELOXICAM - A COMPARISON WITH INTRAMUSCULAR AND ORAL DICLOFENAC IN PATIENTS WITH ACUTE LUMBAGO

In this controlled, randomized, parallel and open multicentre study, t he efficacy and tolerability of a regimen comprising intravenous (i.v. ) meloxicam followed by oral therapy was compared with a standard regi men of intramuscular (i.m.) diclofenac followed by oral dosing in pati ents with acute lumbago. Of a total of 183 patients, 92 were randomize d to receive meloxicam 15 mg i.v. on day I followed by 7 days oral tre atment with one 15 mg tablet daily, and 91 patients received diclofena c 75 mg i.m. on day I followed by 7 days treatment with one 100 mg slo w release tablet daily. Pain on movement and limitation of activities were assessed by patients and physicians using questionnaires. Meloxic am i.v. demonstrated a significantly faster median time of onset of an algesic action (30 minutes), compared with diclofenac i.m. (60 minutes ).;She reduction in pain during movement 30 minutes after injection wa s also significantly in favour of meloxicam. Assessments of global eff icacy indicated that meloxicam was significantly better than diclofena c as rated by investigators (p = 0.02) and patients (p = 0.01). Moreov er, the rating of investigators and patients for local and global tole rance was significantly in favour of meloxicam (p < 0.05) and improvem ents in the quality of life were almost significant (p = 0.053). Fewer adverse events, particularly of a gastrointestinal (GI) nature, occur red in the meloxicam group compared with the diclofenac group. This st udy therefore demonstrates that meloxicam 15 mg i.v. followed by oral therapy is both efficacious and well tolerated in the treatment of acu te lumbago, and compares favourably with the standard NSAID, diclofena c, in this indication.