(744): Efficacy and safety of lumiracoxib 400 mg compared to celecoxib 400 mg or placebo for treatment of pain following dental surgery

Abstract

Lumiracoxib, a potent selective COX 2 inhibitor, has been shown to be rapid acting, effective and well tolerated in patients with post-operative dental pain. This single-center, randomized, double-blind, parallel-group study evaluated the analgesic effect of single doses of lumiracoxib 400 mg, celecoxib 400 mg and placebo in the treatment of post-dental surgery pain in patients who experience moderate to severe pain after the extraction of two or more partially impacted or fully bony impacted molars. A total of 364 patients (aged 18-52 years) were randomized (3:3:1) to treatment with single oral doses of lumiracoxib 400 mg (n=156), celecoxib 400 mg (n=156) or placebo (n=52). The primary efficacy variable was summed (time-weighted) pain intensity difference (categorical scale) calculated over the first 8 hours post-dose time period (SPID-8). Lumiracoxib was statistically superior to celecoxib for SPID-8 (estimated treatment difference: 4.05 [95% CI: 2.33, 5.78]; p<0.001). For the secondary efficacy variable, time-specific pain intensity difference (PID) based on the categorical scale over 0-24 hours, lumiracoxib showed statistically significantly higher levels of analgesia from 30 minutes until 12 hours post-dose compared to celecoxib and from 30 minutes to 24 hours compared to placebo. Additionally, lumiracoxib demonstrated the longest (12.13 hrs) median time-to-first-rescue medication intake compared with celecoxib (3.8 hrs) and placebo (1.28 hrs). In the patient global evaluation assessments, 28.8% of patients evaluated treatment with lumiracoxib as excellent while 18.6% and 1.9% evaluated celecoxib and placebo respectively as excellent. The incidence of adverse events was comparable between treatments (11.5% for lumiracoxib,10.9% for celecoxib and 17.3% for placebo) and there were no serious adverse events or discontinuations due to adverse events. These results demonstrate that a single dose of lumiracoxib 400 mg is well tolerated and provides rapid, effective, sustained relief from postoperative dental pain. Lumiracoxib, a potent selective COX 2 inhibitor, has been shown to be rapid acting, effective and well tolerated in patients with post-operative dental pain. This single-center, randomized, double-blind, parallel-group study evaluated the analgesic effect of single doses of lumiracoxib 400 mg, celecoxib 400 mg and placebo in the treatment of post-dental surgery pain in patients who experience moderate to severe pain after the extraction of two or more partially impacted or fully bony impacted molars. A total of 364 patients (aged 18-52 years) were randomized (3:3:1) to treatment with single oral doses of lumiracoxib 400 mg (n=156), celecoxib 400 mg (n=156) or placebo (n=52). The primary efficacy variable was summed (time-weighted) pain intensity difference (categorical scale) calculated over the first 8 hours post-dose time period (SPID-8). Lumiracoxib was statistically superior to celecoxib for SPID-8 (estimated treatment difference: 4.05 [95% CI: 2.33, 5.78]; p<0.001). For the secondary efficacy variable, time-specific pain intensity difference (PID) based on the categorical scale over 0-24 hours, lumiracoxib showed statistically significantly higher levels of analgesia from 30 minutes until 12 hours post-dose compared to celecoxib and from 30 minutes to 24 hours compared to placebo. Additionally, lumiracoxib demonstrated the longest (12.13 hrs) median time-to-first-rescue medication intake compared with celecoxib (3.8 hrs) and placebo (1.28 hrs). In the patient global evaluation assessments, 28.8% of patients evaluated treatment with lumiracoxib as excellent while 18.6% and 1.9% evaluated celecoxib and placebo respectively as excellent. The incidence of adverse events was comparable between treatments (11.5% for lumiracoxib,10.9% for celecoxib and 17.3% for placebo) and there were no serious adverse events or discontinuations due to adverse events. These results demonstrate that a single dose of lumiracoxib 400 mg is well tolerated and provides rapid, effective, sustained relief from postoperative dental pain.