The post-operative analgesic efficacy and tolerability of lumiracoxib compared with placebo and naproxen after total knee or hip arthroplasty

Background: Lumiracoxib is a novel selective cyclooxygenase-2 (COX-2) inhibitor in development for the treatment of chronic and acute pain. Methods: This randomized, double-blind multicentre study enrolled 180 patients (aged 18-80 years) with moderate-to-severe pain (>= 2 on a 4-point categorical scale) within 48 h of unilateral total knee or total hip arthroplasty. Patients were randomized to receive lumiracoxib 400 mg once daily (n = 60), placebo (n = 60) or naproxen 500 mg twice daily (n = 60). The study consisted of a 12-h single-dose phase followed by a multiple-dose phase (up to 96 h or until discontinuation). The primary efficacy measure was the summed (time-weighted) pain intensity difference over 0-8 h after the first dose (SPID-8). Results: Lumiracoxib and naproxen were comparable and both treatments were superior to placebo for the primary efficacy measure, SPID-8. Both treatments were generally similar and also superior to placebo for the secondary efficacy measures during both the single- and multiple-dose phases for up to 96 h. Both active treatments were well tolerated. Conclusions: Lumiracoxib is an effective alternative to traditional non-selective non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of post-operative pain.