Single dose oral lumiracoxib for postoperative pain in adults Stable (no update expected for reasons given in 'What's new')

Abstract

Abstract Background

Lumiracoxib is a selective cyclooxygenase‐2 (COX‐2) inhibitor. COX‐2 inhibitors were developed to avoid COX‐1‐related gastrointestinal (GI) problems while maintaining the analgesic and anti‐inflammatory activity of traditional non‐steriodal anti‐inflammatory drugs (NSAIDs).

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.

Search methods

We searched Cochrane CENTRAL, MEDLINE, and EMBASE to February 2010.

Selection criteria

Single oral dose, randomised, double‐blind, placebo‐controlled trials of lumiracoxib for relief of established moderate to severe postoperative pain in adults.

Data collection and analysis

Studies were assessed for methodological quality and the data extracted by two review authors independently. Summed total pain relief over six hours (TOTPAR 6) was used to calculate the number of participants achieving at least 50% pain relief. These derived results were used to calculate, with 95% confidence intervals, the relative benefit compared to placebo, and the number needed to treat (NNT) for one participant to experience at least 50% pain relief over six hours. Numbers of participants using rescue medication, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected.

Main results

In this updated review four studies met the inclusion criteria. In total 366 participants were treated with lumiracoxib 400 mg, 51 with lumiracoxib 100 mg, and 212 with placebo. Active comparators were naproxen 500 mg, rofecoxib 50 mg, celecoxib 200 mg, celecoxib 400 mg, and ibuprofen 400 mg. With lumiracoxib 400 mg 50% of participants had at least 50% pain relief over six hours, compared with 8% given placebo; RB 6.9 (95% CI 4.1 to 12), NNT 2.4 (2.1 to 2.8).

Median time to onset of analgesia was shorter for lumiracoxib 400 mg (0.6 to 1.5 hours) than placebo (>12 hours). Fewer participants needed rescue medication with lumiracoxib (64%) than with placebo (91%) over 12 to 24 hours; NNT to prevent remedication 3.7 (2.9 to 5.0). The weighted median time to use of rescue medication was 9.4 hours for lumiracoxib 400 mg and 1.7 hours for placebo.

Adverse events were generally mild to moderate in severity, with one serious event reported in a placebo patient.

Authors' conclusions

Lumiracoxib 400 mg given as a single oral dose is an effective analgesic for acute postoperative pain, and has a relatively long duration of action. Adverse events with lumiracoxib did not differ from placebo.

Author(s)

Yvonne M Roy, Sheena Derry, R Andrew Moore

Abstract

Plain language summary

Single dose oral lumiracoxib (Prexige®) for acute postoperative pain relief in adults 

Postoperative pain is often poorly managed. Cyclooxygenase inhibitors (COX‐2) pain relieving drugs were developed with the aim of reducing the gastrointestinal side effects of non‐steroidal anti‐inflammatory drugs (NSAIDs). Lumiracoxib 400 mg provided rapid, effective, and sustained relief of postoperative pain in four studies in dental and orthopaedic surgery. Of 366 participants treated with lumiracoxib 400 mg half experienced a high level of pain relief (at least 50% pain relief over a six hour period), compared with 8% given placebo. The duration of analgesia was relatively long at 9 hours, and fewer participants needed to use rescue medication with lumiracoxib than with placebo. Adverse event data was inconsistently reported, but no serious adverse events occurred in any patient taking lumiracoxib in these studies.

Author(s)

Yvonne M Roy, Sheena Derry, R Andrew Moore

Reviewer's Conclusions

Authors' conclusions

Implications for practice

This review has found that lumiracoxib is effective at providing postoperative pain relief in approximately half of adult patients, and is comparable to ibuprofen 400 mg, but with a median time to use of rescue medication it has a longer duration of analgesia.  It was not associated with any serious adverse events in this limited data set.

Implications for research

We see no implications for research in the field of single dose acute pain studies. What is lacking are pragmatic studies determining how to ensure that patients achieve clinically relevant, say 50% pain relief, rather than exploratory studies which show that a drug is an analgesic.

In terms of adverse event profiles, this is difficult in a drug like lumiracoxib when it is used for short term studies only. A possible approach might be to study time to event data in large trials of chronic use, although the study population is likely to differ.

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