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

• Published in: Acta anaesthesiologica Scandinavica Vol. 49; no. 10; pp. 1491 - 1500
• Main Authors: Chan, V. W. S., Clark, A. J., Davis, J. C., Wolf, R. S., Kellstein, D., Jayawardene, S.
• Format: Journal Article
• Language: English
• Published: Oxford, UK; Malden, USA Blackwell Publishing Ltd/Inc 01-11-2005; Blackwell
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Analgesics, Opioid - administration & dosage; Analgesics, Opioid - therapeutic use; Anesthesia; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; arthroplasty; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Biological and medical sciences; COX-2 inhibitor; Cyclooxygenase 2 Inhibitors - administration & dosage; Cyclooxygenase 2 Inhibitors - adverse effects; Cyclooxygenase 2 Inhibitors - therapeutic use; Diclofenac - analogs & derivatives; Double-Blind Method; Female; Humans; lumiracoxib; Male; Medical sciences; Middle Aged; Morphine - administration & dosage; Morphine - therapeutic use; naproxen; Naproxen - administration & dosage; Naproxen - adverse effects; Naproxen - therapeutic use; Organic Chemicals - administration & dosage; Organic Chemicals - adverse effects; Organic Chemicals - therapeutic use; Pain Measurement; Pain, Postoperative - drug therapy; post-operative pain; Sample Size; selective cyclooxygenase-2 inhibitor; Knee; selective cyclooxygenase-2 inhibitor; Prostaglandin-endoperoxide synthase; COX-2 inhibitor; Enzyme; arthroplasty; Enzyme inhibitor; Cyclooxygenase 2 inhibitor; Hip; Non steroidal antiinflammatory agent; Analgesic; Pain; Naproxen; Antipyretic; Arylpropionic acid derivatives; Anesthesia; Lumiracoxib; Oxidoreductases; post-operative pain
• ISSN: 0001-5172; 1399-6576
• DOI: 10.1111/j.1399-6576.2005.00782.x

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.
Conclusion:  Lumiracoxib is an effective alternative to traditional non‐selective non‐steroidal anti‐inflammatory drugs (NSAIDs) for the treatment of post‐operative pain.