Single dose oral rofecoxib for postoperative pain

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Background: Editor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater than 18 months) could increase the risk of heart attack and stroke. So far, other similar anti-inflammatory drugs are unaffected. Further information is available at www.vioxx.com. Rofecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor that was licensed in the UK and the US for acute pain treatment and is associated with fewer gastrointestinal adverse events than conventional NSAIDs. Rofecoxib is believed to be 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 a single oral dose of rofecoxib for moderate to severe postoperative pain, and to compare its effectiveness with other analgesics used for treating acute pain.

Search strategy: We searched Cochrane Library (Issue 1, 2002), MEDLINE (1966 to March 2002), Biological Abstracts (1985 to Dec 2001), CINAHL (1982 to Dec 2001), Psychinfo (1967 to Jan 2002), PubMed (March 2001) and the Oxford pain database.

Selection criteria: Randomised controlled trials of adult patients who received either rofecoxib or placebo for postoperative pain.

Data collection and analysis: Trials were quality scored and the data extracted by two reviewers independently. Summed pain relief (TOTPAR) or pain intensity difference (SPID) 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: Seven studies met the inclusion criteria. All the trials were funded by Merck & Company, the manufacturer of rofecoxib. In total, 667 patients were treated with rofecoxib 50 mg and 315 with placebo. The NNT for rofecoxib 50 mg was 2.2 (95% CI 1.9 to 2.4), ie, for every two patients treated with rofecoxib 50 mg, one patient experienced at least 50% pain relief that would not have done had they received placebo. All the studies were of short duration, and reported adverse events occurred less frequently with rofecoxib 50 mg than with placebo.

Authors' conclusions: Rofecoxib 50 mg (a dose 2 to 4 times the standard daily dose for chronic pain) is an effective single dose oral analgesic for acute postoperative pain.