Lornoxicam efficacy in acute pain (LEAP) trial.

ABSTRACT

Parenteral non-steroidal anti-inflammatory drugs (NSAIDs) are useful agents in the treatment of postoperative pain and other acute traumatic painful conditions such as fractures. Clinical trials with lornoxicam, an oxicam derivative, document its efficacy as a potent analgesic with excellent anti-inflammatory properties in painful and or/inflammatory conditions including postoperative pain and arthritic conditions. However, there is no documentation of the efficacy and tolerability of intravenous lornoxicam in Indian patients with acute painful conditions such painful traumatic conditions requiring hospitalisation and parenteral analgesics. The present study was undertaken to evaluate the efficacy and tolerability of intravenous lornoxicam in Indian patients with postoperative pain or other acute painful traumatic conditions requiring hospitalisation and parenteral analgesia in in-office practice conditions. In this multicentric, prospective, open, non-comparative phase IV, postmarketing surveillance study patients admitted in the nursing home for either postoperative pain or painful conditions requiring hospitalisation and parenteral analgesia were enrolled in the study after obtaining their informed consent. Of the 161 patients fulfilling the selection criteria, 148 met the selection criteria and were included in the efficacy analysis. Patients were treated with intravenous lornoxicam 8 mg twice or three times daily as required for up to 3 days. Efficacy variables included changes in severity of pain scores compared to baseline values, onset of pain relief and overall global efficacy. Tolerability was assessed through monitoring of treatment-emergent adverse events, physical examination, assessments of vital signs, and overall global assessment of tolerability. Results indicated that within 1 hour of administration of intravenous lornoxicam, the mean scores of pain severity were reduced by 39.46% and by 6 hours, there was a further 52% reduction in the mean scores. Therapy with intravenous lornoxicam was associated with a faster onset of action with 15.4% patients reporting pain relief within 10 minutes and 55.9% patients within 10 to 30 minutes. Overall, global assessment of efficacy was rated as good to excellent in 95.3% of the patients. Therapy with intravenous lornoxicam was well tolerated with only 5 patients reporting adverse events such as headache (n=3) and gastritis (n=1) of mild to moderate intensity but transient. Overall, global tolerability was rated as good to excellent in 98.4% of the total cases and fair in only 1.6% of the cases. In conclusion, the results of the present study indicate that intravenous lornoxicam is a potent NSAID with an optimal efficacy/toxicity ratio and thus could be a suitable therapeutic option in the management of patients with painful traumatic conditions requiring parenteral NSAIDs and hospitalisation.