BACKGROUND:
Rofecoxib is a
cyclo-oxygenase 2 selective inhibitor. This systematic review of
rofecoxib in
acute pain examined studies in adults of
analgesic efficacy over six hours, the amount and quality of the evidence on extended duration of
analgesia, and the quality and quantity of evidence on adverse events. METHODS: Cochrane Library (issue 4, 2001), Biological Abstracts (March 2002), MEDLINE (March 2002) and PubMed (March 2002) were searched using
rofecoxib as a free text term. The area under the
pain relief versus time curve was dichotomized using validated equations to derive the proportion of patients on
rofecoxib 50 mg or placebo with at least 50%
pain relief over six hours. This was used to calculate the number needed to treat for at least 50%
pain relief over six hours for
rofecoxib compared with placebo. Information on duration of
analgesia and adverse events was also collected. RESULTS: Five included trials investigated 1,118 patients, of whom 211 received placebo and 464 received
rofecoxib 50 mg. The NNT for
rofecoxib 50 mg was 2.3 (95% confidence interval 2.0 to 2.6). The weighted mean remedication time was 1.9 hours for placebo (126 patients), 7.4 hours for
ibuprofen 400 mg (97 patients) and 13.6 hours for
rofecoxib 50 mg (322 patients). CONCLUSION:
Rofecoxib at 2-4 times the standard daily dose for
chronic pain is an effective single dose oral
analgesic in
acute pain. Limitations in trial reporting constrain conclusions about longer duration of
analgesia and adverse event profile.