Analgesic efficacy of single oral doses of lumiracoxib and ibuprofen in patients with postoperative dental pain. Lumiracoxib 400 mg compared with celecoxib 400 mg and placebo for treating pain following dental surgery: a randomized, controlled trial. The post-operative analgesic efficacy and tolerability of lumiracoxib compared with placebo and naproxen after total knee or hip arthroplasty.
This randomised, double-blind study compared single dose lumiracoxib (a cyclooxygenase-2 selective inhibitor) 100 and 400 mg, ibuprofen 400 mg and placebo in patients with postoperative dental pain over 12 h. The primary efficacy variable was pain intensity difference. Lumiracoxib 400 mg and ibuprofen were superior to placebo from 1 to 12 h post dose while lumiracoxib 100 mg was superior from 1.5 to 9 h. Lumiracoxib 400 mg demonstrated the fastest median time to onset of analgesia (37.4 min) followed by ibuprofen (41.5), and lumiracoxib 100 mg (52.4; all p < or = 0.001 vs. placebo). Median time to rescue medication (h) was longer for lumiracoxib 400 mg (> or = 12), lumiracoxib 100 mg (approximately 7) and ibuprofen (approximately 8) than placebo (approximately 2; all p < or = 0.001 vs. placebo). Patients rated lumiracoxib 400 mg superior to the other active treatments (p < 0.05); lumiracoxib 100 mg was comparable with ibuprofen and superior to placebo (p < 0.001). Lumiracoxib provided rapid, effective and well-tolerated analgesia. This randomized, double-blinded, double-dummy, parallel-group, single-center study compared a single dose of the novel selective COX-2 inhibitor lumiracoxib (400 mg), with celecoxib (400 mg) or placebo in dental pain. Patients > or =17 years with moderate-to-severe dental pain were recruited after surgical extraction of 2 or more partially or fully bony impacted molars. Pain intensity was measured using the categorical scale and the primary efficacy variable was the summed pain intensity difference over 8 hours after dosing (SPID-8). Patient disposition and demographics were comparable between lumiracoxib 400 mg (n = 156), celecoxib 400 mg (n = 156), and placebo (n = 52) groups. Lumiracoxib was statistically superior (P < .001) to both celecoxib and placebo in reducing pain intensity (SPID-8; least-squares means: 8.31, lumiracoxib; 4.26, celecoxib; -1.87, placebo). Significantly more patients treated with lumiracoxib (58.9%) considered treatment to be good or excellent compared with celecoxib and placebo (42.3% and 5.7%, respectively; P = .001). Lumiracoxib was superior to celecoxib and placebo for all other secondary efficacy variables. All treatments were well-tolerated. In conclusion, 400 mg lumiracoxib was well-tolerated and provided significantly superior analgesia to 400 mg celecoxib or placebo in patients with moderate-to-severe pain after dental surgery.
                In a randomized, double-blinded, double-dummy, parallel-group, single-center study, a single dose of the novel selective COX-2 inhibitor lumiracoxib (400 mg) was well-tolerated and provided significantly superior analgesia to 400 mg celecoxib or placebo in patients with moderate-to-severe dental pain after surgical extraction of impacted molars. Lumiracoxib is a novel selective cyclooxygenase-2 (COX-2) inhibitor in development for the treatment of chronic and acute pain.
                This randomized, double-blind multicentre study enrolled 180 patients (aged 18-80 years) with moderate-to-severe pain (>or=2 on a 4-point categorical scale) within 48 h of unilateral total knee or total hip arthroplasty. Patients were randomized to receive lumiracoxib 400 mg once daily (n = 60), placebo (n = 60) or naproxen 500 mg twice daily (n = 60). The study consisted of a 12-h single-dose phase followed by a multiple-dose phase (up to 96 h or until discontinuation). The primary efficacy measure was the summed (time-weighted) pain intensity difference over 0-8 h after the first dose (SPID-8).
                Lumiracoxib and naproxen were comparable and both treatments were superior to placebo for the primary efficacy measure, SPID-8. Both treatments were generally similar and also superior to placebo for the secondary efficacy measures during both the single- and multiple-dose phases for up to 96 h. Both active treatments were well tolerated.
                Lumiracoxib is an effective alternative to traditional non-selective non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of post-operative pain.
Lumiracoxib 400 mg given as a single oral dose is an effective analgesic for acute postoperative pain, and has a relatively long duration of action. Adverse events with lumiracoxib did not differ from placebo.