Titre du document / Document title

Comparison of rofecoxib and oxycodone plus acetaminophen in the treatment of acute pain: A randomized, double-blind, placebo-controlled study in patients with moderate to severe postoperative pain in the third molar extraction model

Auteur(s) / Author(s)

KORN Scott ⁽¹⁾ ; VASSIL Theodore C. ⁽¹⁾ ; KOTEY Paul N.-A. ⁽¹⁾ ; FRICKE James R. ⁽²⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Merck Research Laboratories, West Point, Pennsylvania, ETATS-UNIS
⁽²⁾ PPD-Pharmaco, Austin, Texas, ETATS-UNIS

Résumé / Abstract

Background: Opiates, acetaminophen, nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), and cyclooxygenase-2-selective inhibitors such as rofecoxib are used in the treatment of acute pain because of their anti-inflammatory and/or analgesic properties. Rofecoxib has demonstrated an improved gastrointestinal safety profile compared with nonselective NSAIDs. Objective: The aim of this study was to compare the analgesic efficacy and tolerability profile of rofecoxib 50 mg with those of the centrally acting, nonsalicylate, opiate/nonopiate analgesic combination oxycodone/ acetaminophen 5/325 mg in patients with pain after dental surgery. Methods: In this randomized, double-blind, placebo- and active comparator-controlled study, patients experiencing moderate to severe postoperative pain after extraction of ≥2 third molars (including ≥1 mandibular impaction) received a single oral dose of rofecoxib 50 mg, oxycodone/acetaminophen 5/325 mg, or placebo. End points included total pain relief over 6 hours (TOPAR6, the primary end point) and 4 hours (TOPAR4), patients global assessment of treatment at 6 hours (GLOBAL6) and 24 hours (GLOBAL24), summed pain intensity difference over 6 hours (SPID6), onset of analgesic effect (time to perceptible/meaningful pain relief, using a 2-stopwatch method), peak pain relief (PEAKPR), peak pain intensity difference (PEAKPID), and duration of analgesic effect (time to use of rescue analgesia). Results: Two hundred twelve patients (63% female, 37% male; 76% white, 24% other; mean [SD] age, 20.9 [4.4] years; age range, 16-41 years) were enrolled in the study and received a single oral dose of rofecoxib 50 mg (n = 90), oxycodone/acetaminophen 5/325 mg (n = 91), or placebo (n = 31). The analgesic effect of rofecoxib was significantly greater than that of oxycodone/acetaminophen at P < 0.001 for TOPAR6, TOPAR4, GLOBAL6, GLOBAL24, and SPID6; at P < 0.010 for PEAKPR and PEAKPID; and at P < 0.001 for median time to use of rescue analgesia. Significantly fewer patients in the rofecoxib group (72.2%) took rescue analgesia within 24 hours postdose compared with the oxycodone/acetaminophen group (94.5%; P < 0.001) and the placebo group (96.8%; P < 0.02). Both active treatments were similar with respect to onset of analgesic effect. Both were generally well tolerated; the overall incidence of adverse experiences in the rofecoxib, oxycodone/acetaminophen, and placebo groups was 51.1%, 64.8%, and 48.4%, respectively Rofecoxib was associated with a significantly lower incidence of nausea (18.9% vs 39.6%; P < 0.001) and vomiting (6.7% vs 23.1%; P < 0.001) compared with oxycodone/acetaminophen. Conclusions: In study patients with moderate to severe pain after dental surgery, rofecoxib 50 mg had a greater analgesic effect than oxycodone/acetaminophen 5/325 mg and was associated with less nausea and vomiting.

Revue / Journal Title

Clinical therapeutics   ISSN 0149-2918 

Source / Source

2004, vol. 26, n^o5, pp. 769-778 [10 page(s) (article)] (33 ref.)

Langue / Language

Anglais

Editeur / Publisher

Excerpta Medica, Belle Mead, NJ, ETATS-UNIS  (1977) (Revue)

Mots-clés anglais / English Keywords

Opiates ; Enzyme ; Oxidoreductases ; Prostaglandin-endoperoxide synthase ; Enzyme inhibitor ; Cyclooxygenase 2 inhibitor ; Antimigrainous agent ; Antipyretic ; Narcotic analgesic ; Non steroidal antiinflammatory agent ; Human ; Double blind study ; Randomization ; Pain ; Treatment ; Paracetamol ; Oxycodone ; Comparative study ; Rofecoxib ;

Mots-clés français / French Keywords

Opiacés ; Enzyme ; Oxidoreductases ; Prostaglandin-endoperoxide synthase ; Inhibiteur enzyme ; Inhibiteur cyclooxygenase 2 ; Antimigraineux ; Antipyrétique ; Analgésique narcotique ; Antiinflammatoire non stéroïde ; Homme ; Etude double insu ; Randomisation ; Douleur ; Traitement ; Paracétamol ; Oxycodone ; Etude comparative ; Rofécoxib ;

Mots-clés espagnols / Spanish Keywords

Opiados ; Enzima ; Oxidoreductases ; Prostaglandin-endoperoxide synthase ; Inhibidor enzima ; Inhibidor cyclooxygenase 2 ; Agente antimigrañoso ; Antipirético ; Analgésico narcotico ; Antiinflamatorio no esteroide ; Hombre ; Estudio doble ciego ; Aleatorización ; Dolor ; Tratamiento ; Paracetamol ; Oxicodona ; Estudio comparativo ; Rofecoxib ;

Mots-clés d'auteur / Author Keywords

rofecoxib ; oxycodone/acetaminophen ; dental pain ; analgesia ; acute pain ; postsurgery ;

Localisation / Location

INIST-CNRS, Cote INIST : 18353, 35400011208072.0130