NSAIDs and acetaminophen: Analgesic effect of rofecoxib 50 mg and valdecoxib 40 mg on postoperative pain: a randomized, placebo-controlled study

Abstract

The selective cyclooxygenase (COX)-2 inhibitors, rofecoxib (ROF) and valdecoxib (VAL), have demonstrated efficacy comparable to NSAIDs in various pain models. This study compared the analgesic efficacy of single doses of ROF 50 mg (approved acute pain dose) with VAL 40 mg (twice the maximum approved dose) in postoperative dental pain. This randomized, double-blind study enrolled 125 patients to treatment with single doses of ROF 50 mg (N=51), VAL 40 mg (N=50), or placebo (N=24). Patient pain intensity and pain relief were assessed at 16 prespecified time points over 24 hours using standard scales. The primary endpoint was total pain relief over 12 hours (TOPAR12). Other measurements included patient global assessment at 12 hours, median time to confirmed perceptible pain relief (onset of analgesia), peak pain relief (peak analgesic effect), and median time to rescue medication (duration of effect). Baseline characteristics among the groups were similar. TOPAR12 scores (range 0-48) were similar (p=0.574) between ROF (27.0) and VAL (28.6). ROF and VAL, respectively, provided a similar responder rates on patient global assessment at 12 hours (76% vs 74%) and peak pain relief (3.1 vs. 3.0, range 0-4). Onset of analgesia was similar (<45 minutes) and was achieved by 78% of ROF and 74% of VAL patients. Analgesia duration was also similar (>24hrs). Improvement on all endpoints with active treatments compared to placebo were significant (p<0.001). Incidence of adverse experiences was 35% with ROF compared to 50% for VAL (NS). Adverse experience incidence compared to placebo (71%) was significantly less with ROF (p<0.01), but not with VAL. Placebo events were likely attributable to rescue medication. ROF 50 mg and VAL 40 mg provide similar analgesic effect in postsurgical dental pain setting and were generally well-tolerated.