A total of 13 studies were included in the efficacy analysis of refocoxib versus placebo (n=1,900). Eleven of these were included in the meta-analysis of onset and duration (n=1,703).
Eight of the RCTs also included a non-selective NSAID treatment arm and were included in the analyses of non-selective NSAIDs (n=391).
Onset of efficacy.
Rofecoxib showed a median time to onset of analgesia of 34 minutes (95% CI: 31, 38) compared with over 4 hours for placebo (P<0.001). Six studies of non-selective NSAIDs showed a similar median time to onset of analgesia (30 minutes, 95% CI: 28, 37). Similar values were observed for the median time to perceptible pain relief.
Onset of analgesia was achieved by 77% (range: 64, 88) of rofecoxib patients, 76% (range: 63, 87) of non-selective NSAID patients and 23% (range: 11, 43) of placebo patients. The OR was 10.9 (95% CI: 8.4, 14.2) for rofecoxib versus placebo and 11.5 (95% CI: 7.8, 16.8) non-selective NSAID versus placebo. A similar pattern of results was observed for the achievement of perceptible pain relief.
Duration of analgesia.
Median time to rescue medication was 9 hours 16 minutes (9:16) in placebo patients (95% CI: 6:56, 17:21) versus more than 24 hours for rofecoxib patients (range: 10:22, >24), (P<0.001 for the difference). The results for non-selective NSAIDs were not given.
Overall analgesic efficacy.
The mean TOPAR8 score was 17.4 (95% CI: 16.9, 18) for rofecoxib and 4.4 (95% CI: 3.7, 5.2) for placebo. The difference between groups was significant (P<0.001). The mean TOPAR8 score for non-selective NSAIDs was similar to rofecoxib (15.2, 95% CI: 14.3, 16.1). Similar results were observed for patient global assessment of response to therapy at 24 hours.
Significant differences between the groups in terms of drug-related adverse experiences, serious adverse experiences, and discontinuations due to adverse experiences were not observed. Compared with placebo, rofecoxib was associated with significantly less headaches, nausea and vomiting, but significantly more postextraction alveolitis (dry socket). There were no significant differences between non-selective NSAIDs and placebo.
The authors did not report any statistical heterogeneity between the trials for any comparison.