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Meta-Analysis
. 2007 Oct 17:(4):CD006865.
doi: 10.1002/14651858.CD006865.

Single dose oral lumiracoxib for postoperative pain

Affiliations
Meta-Analysis

Single dose oral lumiracoxib for postoperative pain

Y M Roy et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Lumiracoxib is a novel selective cyclooxygenase-2 (COX-2) inhibitor. COX-2 inhibitors have been developed to avoid COX-1 related gastrointestinal (GI) problems. Lumiracoxib has analgesic and anti-inflammatory activity comparable with traditional non-steroidal anti-inflammatory drugs (tNSAIDs) in the management of post-operative pain, but with the advantage of better GI tolerability.

Objectives: To review the analgesic efficacy, duration of analgesia, and adverse effects of a single oral dose of lumiracoxib for moderate to severe postoperative pain in adults and compare it with established analgesics.

Search strategy: We searched CENTRAL (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to March 2007), EMBASE (1974 to 2006), and PubMed (February 2007).

Selection criteria: Single oral dose, randomised placebo controlled trials of lumiracoxib, in acute postoperative pain, in adult patients.

Data collection and analysis: Trials were quality scored and data extracted by two review authors independently. Summed pain relief (TOTPAR) was extracted and converted into dichotomous information yielding the number of patients with at least 50% pain relief. These derived results were used to calculate the relative benefit (RB) and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief.

Main results: Three studies (737 patients) met the inclusion criteria. In total 211 patients were treated with lumiracoxib 400 mg, 51 with lumiracoxib 100 mg, and 161 with placebo. Active comparators were naproxen 500 mg (60 patients), rofecoxib 50 mg (102), celecoxib 200 mg (101), and ibuprofen 400 mg (51). One hundred patients (48%) given lumiracoxib 400 mg had at least 50% pain relief over six hours, compared with 17 (11%) given placebo; RB 4.8 (95% CI 2.9 to 7.9), NNT 2.7 (2.2 to 3.5). Weighted median time to use of rescue medication was 7.4 hours for lumiracoxib 400 mg and 1.8 hours for placebo. Patient global assessment at study endpoint was rated as "excellent" by 71 patients (34%) given lumiracoxib 400 mg and 5 (3%) given placebo. Median time to onset of analgesia was shorter for lumiracoxib 400 mg (0.6 to 1.5 hours) than placebo (>12 hours), and use of rescue medication within 12 hours occurred in 64 patients (58%) given lumiracoxib 400 mg and 100 (91%) given placebo. Adverse events reported were generally mild to moderate in severity, with one serious adverse event reported in a patient given placebo.

Authors' conclusions: Lumiracoxib 400 mg given as a single oral dose, is an effective analgesic for acute postoperative pain.

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References

References to studies included in this review

    1. Chan VWS, Clark AJ, Davis JC, Wolf RS, Kellstein D, Jayawardene S. The post-operative analgesic efficacy and tolerability of lumiracoxib compared with placebo and naproxen after total knee or hip arthroplasty. Acta Anaesthesiologica Scandinavica. 2005;49(10):1491–500. - PubMed
    1. Kellstein D, Ott D, Jayawardene S, Fricke J. Analgesic efficacy of a single dose of lumiracoxib compared with rofecoxib, celecoxib and placebo in the treatment of post-operative dental pain. International Journal of Clinical Practice. 2004;58(3):244–50. - PubMed
    1. Zelenakas K, Fricke JR, Jr, Jayawardene S, Kellstein D. Analgesic efficacy of single oral doses of lumiracoxib and ibuprofen in patients with postoperative dental pain. International Journal of Clinical Practice. 2004;58(3):251–6. - PubMed

References to studies excluded from this review

    1. Bitner M, Katterhorn J, Hatfield C, Gao J, Kellstein D. Efficacy and tolerability of lumiracoxib in the treatment of primary dysmenorrhoea. International Journal Clinical Practice. 2004;58(4):340–5. - PubMed
    1. Schnitzer TJ, Beier J, Geusens P, Hasler P, Patel SK, Senftleber I, et al. Efficacy and safety of four doses of lumiracoxib versus diclofenac in patients with knee or hip primary osteoarthritis: A phase II, four week, multicenter randomised, double blind, placebo-controlled trial. Arthritis and Rheumatism. 2004;51(4):549–57. - PubMed

References to ongoing studies

    1. Novartis Pharmaceuticals Efficacy of lumiracoxib in relieving moderate to severe post-dental pain, compared to both placebo and celecoxib. www.controlled-trials.com/mrct/trial/printfriendly/179985
    1. Novartis Pharmaceuticals Efficacy and safety of lumiracoxib in arthroscopic knee surgery. www.controlled-trials.com/mrct/trialprintfriendly/177605

Additional references

    1. Adebayo D, Bjarnason I. Is non-steroidal anti-inflammatory drug (NSAID) enteropathy clinically more important than NSAID gastropathy? Post Graduate Medical Journal. 2006;82(965):186–91. - PMC - PubMed
    1. Bandolier Acute Pain Analgesic League Table [accessed March 2007]; http://www.jr2.ox.ac.uk/Bandolier/booth/painpag/Acutrev/Analgesics/Leagt...
    1. Bannworth B, Berenbaum F. Clinical pharmacology of lumiracoxib, a second generation cyclooxygenase 2 selective inhibitor. Expert Opinion on Investigational Drugs. 2005;14(4):521–33. - PubMed
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    1. Benson WG, Zhao SZ, Burke TA, Zabinski RA, Makuch RW, Maurauth CJ, et al. Upper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo. Journal of Rheumatology. 2000;27:1876–83. - PubMed

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