A randomized, double-blind, parallel-group study comparing the analgesic effect of etoricoxib to placebo, naproxen sodium, and acetaminophen with codeine using the dental impaction pain model.
OBJECTIVE
To compare the overall analgesic effect, including time to onset, peak and duration of effect for etoricoxib 120 mg, a new COX-2 selective inhibitor, in patients with acute pain to that of placebo. Naproxen sodium 550 mg and acetaminophen/codeine 600/60 mg were the active comparators.


METHODS
A total of 201 patients with moderate to severe pain following surgical extraction of > or = 2 third molars, of which at least the mandibular tooth was impacted, were randomly allocated to receive single oral doses of placebo (n = 50), etoricoxib 120 mg (n = 50), naproxen sodium 550 mg (n = 51), or acetaminophen/codeine 600/60 mg (n = 50). The endpoints included total pain relief over 8 hours (TOPAR8, primary end point), sum of pain intensity difference over 8 hours, patient's global evaluation, onset, peak, and duration of analgesia.


RESULTS
Etoricoxib 120 mg had a significantly greater least squares (LS) mean TOPAR8 score than placebo (20.9 vs 5.4; P < 0.001) and acetaminophen/codeine 600/60 mg (20.9 vs 11.5; P < 0.001), and a similar LS mean TOPAR8 score to naproxen sodium 550 mg (20.9 vs 21.3). All three active treatments had rapid onset of analgesia, median time approximately 30 minutes. The duration of analgesic effect, defined as median time to rescue medication use, was >24 hours for etoricoxib, 20.8 hours for naproxen sodium, 3.6 hours for acetaminophen/codeine, and 1.6 hours for placebo.


CONCLUSIONS
Etoricoxib is a new COX-2 selective inhibitor under development for treatment of osteoarthritis, rheumatoid arthritis, and acute pain. In this study, etoricoxib 120 mg provided rapid and long-lasting pain relief to patients with moderate-to-severe postdental surgery pain. Etoricoxib was generally well tolerated.
Malmstrom
Kerstin
K
Department of Clinical Immunology & Analgesia and Department of Biostatistics, Merck Research Laboratories, Rahway, NJ 07065, USA. kerstin_malmstrom@merck.com
Kotey
Paul
P
Coughlin
Heather
H
Desjardins
Paul J
PJ
D000082:Acetaminophen / Q000627:therapeutic use*; D000328:Adult; D000698:Analgesia; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D016022:Case-Control Studies; D003061:Codeine / Q000627:therapeutic use*; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D008297:Male; D009288:Naproxen / Q000627:therapeutic use*; D009294:Narcotics / Q000627:therapeutic use; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D010919:Placebos; D011725:Pyridines / Q000627:therapeutic use*; D012647:Self-Assessment; D013450:Sulfones / Q000627:therapeutic use*; D013997:Time Factors; D014095:Tooth, Impacted / Q000150:complications
D018712:Analgesics, Non-Narcotic; D016861:Cyclooxygenase Inhibitors; D009294:Narcotics; D010919:Placebos; D011725:Pyridines; D013450:Sulfones; D000082:Acetaminophen; D009288:Naproxen; D003061:Codeine; D000077613:Etoricoxib