title: Evaluation of the dose range of etoricoxib in an acute pain setting using the postoperative dental pain model.
abstract: OBJECTIVE
  This study was conducted to evaluate the dose range of etoricoxib in acute pain using the postoperative dental pain model further.
  
  
  METHODS
  This double-blind, randomized controlled study evaluated etoricoxib (90 and 120 mg), ibuprofen (600 mg), and acetaminophen (600 mg/codeine) (60 mg, (A/C)) in patients aged ≥ 18 years with moderate or severe pain after surgical extraction of ≥ 2 third molars (≥ 1 impacted). The patients reported pain intensity and pain relief over 24 hours. The primary efficacy endpoint was total pain relief over 6 hours (TOPAR6). Adverse events were evaluated throughout the study.
  
  
  RESULTS
  There were 588 patients randomized to placebo (n=46),etoricoxib (90 mg (n=191)), etoricoxib (120 mg (n=97)), ibuprofen(2400 mg (n=192)), and A/C (n=62). The overall analgesic effect (TOPAR6) of etoricoxib (90, 120 mg) was significantly greater than that of placebo (P ≤ 0.001), and not inferior to that of ibuprofen; no discernible difference was observed between etoricoxib 90 and 120 mg. Both etoricoxib doses were superior to A/C (P ≤ 0.001). Etoricoxib (90 and 120 mg) and ibuprofen(2400 mg) were generally well tolerated and had a similar incidence of adverse events (AEs). A/C was associated with significantly more AEs that led to discontinuation (ie, nausea and vomiting).
  
  
  CONCLUSIONS
  Etoricoxib (90 and 120 mg) showed similar efficacy in the postoperative dental pain model, which was noninferior to ibuprofen and superior to A/C. A higher number of tooth extractions or a higher mean impaction score may have led to a greater separation in efficacy between the 2 etoricoxib doses.
authors.affiliation: Premier Research Group, 3200 Red River Boulevard, Austin, TX 78705, USA. stephen.daniels@premier-research.com
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Daniels
authors.forename: Donald P
authors.initials: DP
authors.lastname: Bandy
authors.forename: Steven E
authors.initials: SE
authors.lastname: Christensen
authors.forename: Judith
authors.initials: J
authors.lastname: Boice
authors.forename: Maria C
authors.initials: MC
authors.lastname: Losada
authors.forename: Hui
authors.initials: H
authors.lastname: Liu
authors.forename: Anish
authors.initials: A
authors.lastname: Mehta
authors.forename: Paul M
authors.initials: PM
authors.lastname: Peloso
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000766:Anesthesia, Dental; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000627:therapeutic use*; D003061:Codeine / Q000627:therapeutic use; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D016018:Least-Squares Analysis; D008297:Male; D008964:Molar, Third / Q000601:surgery; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement / Q000187:drug effects; D010149:Postoperative Pain / Q000188:drug therapy*; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D013450:Sulfones / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D014081:Tooth Extraction; D014095:Tooth, Impacted / Q000473:pathology / Q000601:surgery; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D004338:Drug Combinations; D011725:Pyridines; D013450:Sulfones; C526278:acetaminophen, codeine drug combination; D000082:Acetaminophen; D003061:Codeine; D007052:Ibuprofen; D000077613:Etoricoxib