The optimal analgesic dose of rofecoxib: Overview of six randomized controlled trials.
BACKGROUND
Rofecoxib, which specifically inhibits cyclooxygenase-2, is indicated for relief of the signs and symptoms of osteoarthritis and for the management of acute pain in adults. The authors present an overview of six placebo-controlled trials designed to evaluate the single-dose analgesic efficacy of a range of doses of rofecoxib in the treatment of postoperative dental pain.


METHODS
The six studies included doses of rofecoxib ranging from 7.5 to 500 milligrams. Maximal analgesic doses of a nonsteroidal anti-inflammatory drug, or NSAID, either naproxen sodium (550 mg) or ibuprofen (400 mg), were used as active comparators in each study. Analgesic efficacy was assessed with the use of validated self-administered questionnaires. The primary endpoint in each study was the total pain relief over the eight-hour postdose period. Additional endpoints were used to characterize the onset of analgesia and peak analgesic effect.


RESULTS
The results of these studies demonstrated that the efficacy of rofecoxib was dose-related, with 50 mg being consistently more effective than placebo for all measures of analgesic efficacy. Moreover, 50 mg was the lowest dose that reproducibly demonstrated an analgesic effect comparable to the effect of maximum single analgesic doses of NSAIDs.


CONCLUSIONS
The results of these studies support the recommended dose of 50 mg of rofecoxib once daily for the management of pain.


CONCLUSIONS
Rofecoxib, at a dose of 50 mg, is effective in the management of postoperative dental pain.
Morrison
B W
BW
Merck Research Laboratories, 126 E. Lincoln Ave., RY32-641, Rahway, N.J. 07065, USA. briggs_morrison@merck.com
Fricke
J
J
Brown
J
J
Yuan
W
W
Kotey
P
P
Mehlisch
D
D
D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage*; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage; D007527:Isoenzymes / Q000037:antagonists & inhibitors; D007783:Lactones / Q000008:administration & dosage*; D008297:Male; D008565:Membrane Proteins; D008875:Middle Aged; D008964:Molar, Third / Q000601:surgery; D009288:Naproxen / Q000008:administration & dosage; D010147:Pain Measurement; D010149:Postoperative Pain / Q000517:prevention & control*; D016016:Proportional Hazards Models; D011451:Prostaglandin-Endoperoxide Synthases; D018709:Statistics, Nonparametric; D013450:Sulfones; D016019:Survival Analysis; D013997:Time Factors; D014081:Tooth Extraction
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D004791:Enzyme Inhibitors; D007527:Isoenzymes; D007783:Lactones; D008565:Membrane Proteins; D013450:Sulfones; C116926:rofecoxib; D009288:Naproxen; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases; D007052:Ibuprofen