Abstract

Background

Editor's note: The anti‐inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long‐term use (greater than 18 months) could increase the risk of heart attack and stroke in a study of secondary prevention of adenoma recurrence. Further information is available at www.vioxx.com.

Rofecoxib is a selective cyclooxygenase‐2 (COX‐2) inhibitor previously licensed for treating acute and chronic pain; it was associated with fewer gastrointestinal adverse events than conventional NSAIDs. An earlier Cochrane review (Barden 2005) showed that rofecoxib is at least as effective as conventional non‐steroidal anti‐inflammatory drugs (NSAIDs) for postoperative pain.

Objectives

To assess the analgesic efficacy and adverse effects of rofecoxib in single oral doses for moderate and severe postoperative pain.

Search methods

We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to June 2009.

Selection criteria

Randomised, double blind, placebo‐controlled trials of single dose orally administered rofecoxib in adults with moderate to severe acute postoperative pain.

Data collection and analysis

Two review authors independently assessed trial quality and extracted data. Pain relief or pain intensity data were extracted and converted into the dichotomous outcome of number of participants with at least 50% pain relief over 4 to 6 hours, from which relative risk and number needed to treat to benefit (NNT) were calculated. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected.

Main results

Twenty new studies and seven from the earlier review met the inclusion criteria. Twenty‐four studies were in dental surgery and three in other types of surgery. In total, 2636 participants were treated with rofecoxib 50 mg, 20 with rofecoxib 500 mg, and 1251 with placebo. The NNT for at least 50% pain relief over 4 to 6 hours with rofecoxib 50 mg was 2.2 (2.0 to 2.3) in all studies combined, 1.9 (1.8 to 2.0) in dental studies, and 6.8 (4.6 to 13) in other types of surgery. The median time to use of rescue medication was 14 hours for rofecoxib 50 mg and 2 hours for placebo. Significantly fewer participants used rescue medication following rofecoxib 50 mg than with placebo. Adverse events did not differ from placebo.

Authors' conclusions

Rofecoxib 50 mg (two to four times the standard daily dose for chronic pain) is an effective single dose oral analgesic for acute postoperative pain in adults, with a relatively long duration of action.

Author(s)

Simon Bulley, Sheena Derry, R Andrew Moore, Henry J McQuay

Abstract

Plain language summary

Single dose oral rofecoxib for acute postoperative pain in adults

A high level of pain relief is experienced by about 60% of those with moderate to severe postoperative pain after a single dose of rofecoxib 50 mg, compared to about 10% with placebo. Based mainly on dental pain studies, one in every two participants treated with rofecoxib 50 mg had their pain levels halved, who would not have done so with placebo. Fewer people needed rescue medication with rofecoxib, and the time to use was relatively long, at 14 hours. Its efficacy and duration of action are better than that of many commonly used analgesics at standard doses. Efficacy was better in dental surgery than in other types of surgery. Adverse events did not differ from placebo in these single dose studies.- - Editor's note: The anti‐inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long‐term use (greater than 18 months) could increase the risk of heart attack and stroke in a study of secondary prevention of adenoma recurrence. Further information is available at www.vioxx.com.

Author(s)

Simon Bulley, Sheena Derry, R Andrew Moore, Henry J McQuay

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Rofecoxib 50 mg is an effective single dose oral analgesic in acute, moderate to severe, postoperative pain. It provides at least 50% pain relief to over half of participants treated. The NNT of 2.2 for at least 50% pain relief over 4 to 6 hours compares favourably with other analgesics commonly used for postoperative pain. It also has a long duration of action compared with other analgesics, the median time to remedication for rofecoxib 50 mg being 14 hours. Rofecoxib 50 mg is associated with a low rate of adverse events in single dose, similar to that with placebo. There is a large, high quality data set available for rofecoxib 50 mg in acute postoperative pain, suggesting that these conclusions should be robust.

Implications for research 

There is no obvious requirement for further research in classical acute pain trials for two reasons. There is already a large body of data providing results unlikely to change with more trials. In addition, the licensed status of rofecoxib in many parts of the world make it unlikely to be used, making new research in the acute pain model unnecessary.

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