Titre du document / Document title

Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa of patients with osteoarthritis a randomized, double-blind, placebo-controlled trial

Auteur(s) / Author(s)

Rofecoxib Osteoarthritis Endoscopy Multinational Study Group
HAWKEY C. ^{(1 2)} ; LAINE L. ^{(2 3)} ; SIMON T. ^{(2 4)} ; BEAULIEU A. ⁽⁵⁾ ; MALDONADO-COCCO J. ⁽⁶⁾ ; ACEVEDO E. ⁽⁷⁾ ; SHAHANE A. ⁽⁴⁾ ; HUI QUAN ^{(2 4)} ; BOLOGNESE J. ^{(2 4)} ; MORTENSEN E. ^{(2 4)} ;

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

⁽¹⁾ University Hospital Queen's Medical Centre, Nottingham, ROYAUME-UNI
⁽²⁾ Merck & Company, Inc., Whitehouse Station, New Jersey, ETATS-UNIS
⁽³⁾ University of Southern California, Los Angeles, ETATS-UNIS
⁽⁴⁾ Mcrck Research Laboratories, West Point, Pennsylvania, ETATS-UNIS
⁽⁵⁾ Centre de Recherche Immunologie/Rhumatologie, Sainte-Foy, Quebec, CANADA
⁽⁶⁾ Instituto Municipal de Rehabilitacion Psicofisica, Buenos Aires, ARGENTINE
⁽⁷⁾ Clinica San Felipe, Lima, PEROU

Résumé / Abstract

Objective. This randomized, double-blind study tested the hypothesis that rofecoxib, a drug that specifically inhibits cyclooxygenase 2, would cause fewer gastroduodenal ulcers than ibuprofen (in a multicenter trial), and its side effects would be equivalent to those of placebo (in a prespecified analysis combining the results with another trial of identical design). Methods. Seven hundred seventy-five patients with osteoarthritis were randomized to receive rofecoxib at a dosage of 25 mg or 50 mg once daily, ibuprofen 800 mg 3 times daily, or placebo. Gastroduodenal ulceration was assessed by endoscopy at 6, 12, and (for active treatment) 24 weeks. The primary and secondary end points were the incidence of gastroduodenal ulcers at 12 and 24 weeks, respectively. Results. Ulcers were significantly less common (P < 0.001) following treatment with rofecoxib (25 mg or 50 mg) than with ibuprofen after 12 weeks (5.3% and 8.8% versus 29.2%, respectively) or 24 weeks (9.9% and 12.4% versus 46.8%, respectively). In the combined analysis, the 12-week ulcer incidence with 25 mg rofecoxib (4.7%) and with placebo (7.3%) satisfied prespecified criteria for equivalence. Conclusion. At 2-4 times the therapeutically effective dose, rofecoxib caused fewer endoscopically detected ulcers than did ibuprofen. Rofecoxib at a dose of 25 mg (the highest dose recommended for osteoarthritis) satisfied prespecified criteria for equivalence to placebo.

Revue / Journal Title

Arthritis and rheumatism   ISSN 0004-3591   CODEN ARHEAW 

Source / Source

2000, vol. 43, n^o2, pp. 370-377 (27 ref.)

Langue / Language

Anglais

Editeur / Publisher

Wiley, Hoboken , NJ, ETATS-UNIS  (1958) (Revue)

Mots-clés anglais / English Keywords

Osteoarthritis ; Treatment ; Chemotherapy ; Ibuprofen ; Comparative study ; Placebo ; Ulcer ; Gastroduodenal ; Toxicity ; Biological effect ; Enzyme inhibitor ; Prostaglandin-endoperoxide synthase ; Non steroidal antiinflammatory agent ; Human ; Clinical trial ; Arylpropionic acid derivatives ; Oxidoreductases ; Enzyme ; Diseases of the osteoarticular system ; Arthropathy ; Degenerative disease ; Digestive diseases ; Gastric disease ; Intestinal disease ;

Mots-clés français / French Keywords

Arthrose ; Traitement ; Chimiothérapie ; Ibuprofène ; Etude comparative ; Placebo ; Ulcère ; Gastroduodénal ; Toxicité ; Effet biologique ; Inhibiteur enzyme ; Prostaglandin-endoperoxide synthase ; Antiinflammatoire non stéroïde ; Homme ; Essai clinique ; Arylpropionique acide dérivé ; Rofecoxib ; Inhibiteur COX2 ; Oxidoreductases ; Enzyme ; Système ostéoarticulaire pathologie ; Arthropathie ; Maladie dégénérative ; Appareil digestif pathologie ; Estomac pathologie ; Intestin pathologie ;

Mots-clés espagnols / Spanish Keywords

Artrosis ; Tratamiento ; Quimioterapia ; Ibuprofeno ; Estudio comparativo ; Placebo ; Ulcera ; Gastroduodenal ; Toxicidad ; Efecto biológico ; Inhibidor enzima ; Prostaglandin-endoperoxide synthase ; Antiinflamatorio no esteroide ; Hombre ; Ensayo clínico ; Arilpropionico ácido derivado ; Oxidoreductases ; Enzima ; Sistema osteoarticular patología ; Artropatía ; Enfermedad degenerativa ; Aparato digestivo patología ; Estómago patología ; Intestino patología ;

Localisation / Location

INIST-CNRS, Cote INIST : 8711, 35400008195910.0170