Comparison of Lornoxicam and Rofecoxib in Patients with Activated Osteoarthritis (COLOR Study).

BACKGROUND AND OBJECTIVE

Impaired mobility and pain mean a loss of quality of life for patients with rheumatic diseases. Therefore the initial aim of therapy is rapid and efficient analgesia in order to achieve the best possible result for these patients. Lornoxicam is a strong analgesic and anti-inflammatory NSAID with balanced cyclo-oxygenase (COX)-1/COX-2 inhibition and excellent tolerability. In the course of the development of selective COX-2 inhibitors, it was maintained that COX-2 inhibitors decrease the risk of injury to the upper gastrointestinal (GI) tract with a similar efficacy to that of classic NSAIDs. However, a clinical trial comparing both substances has never been performed. In the present study we investigated the treatment of patients with osteoarthritis with lornoxicam in comparison with treatment with the selective COX-2 inhibitor rofecoxib. This multicentre clinical investigation focused on efficacy and tolerability.

PATIENTS AND METHODS

A total of 2520 patients (most of them with osteoarthritis) were treated over 25 days on average. Before and after treatment patients documented their individual scores for pain on movement, at rest and during the night, and their individual duration of morning stiffness as well as the consequent grade of restriction. At the end of the study all individuals involved judged the efficacy and safety of the therapy.

RESULTS

All improvements in each efficacy parameter were clinically relevant in each treatment group and significantly superior (p < 0.001) in the lornoxicam group. Pain on movement (-45.3%), at rest (-42.0%) and at night (-42.5%) was reduced by rofecoxib, whereas improvements after treatment with lornoxicam exceeded those effects significantly (-55.8%, -55.8% and -59.9%, respectively). Shortening of the duration of morning stiffness was significantly (p < 0.001) more pronounced with lornoxicam (-66.6%) than with rofecoxib (-50.2%). Nearly three times as many patients discontinued rofecoxib treatment because of lack of efficacy compared with lornoxicam treatment (8.9% versus 3.4%). Physicians judged lornoxicam to be markedly superior to rofecoxib, since excellent efficacy was observed in 40.9% of all cases versus 20.1% with rofecoxib. Serious adverse events did not occur. Adverse events were reported in 5.4% of all lornoxicam patients compared with 12.0% of the rofecoxib recipients (p < 0.001). GI symptoms showed a slight trend of being less frequent following rofecoxib therapy.

CONCLUSIONS

The results of this study confirmed the efficacy and safety of both drugs. Lornoxicam and rofecoxib are effective in the treatment of patients with activated osteoarthritis; the analgesic and anti-inflammatory effects of lornoxicam are significantly superior to those of rofecoxib without inferiority in tolerability.