Titre du document / Document title

Incidence of gastroduodenal ulcers associated with valdecoxib compared with that of ibuprofen and diclofenac in patients with osteoarthritis

Auteur(s) / Author(s)

SIKES David H. ⁽¹⁾ ; AGRAWAL Naurang M. ⁽²⁾ ; ZHAO William W. ⁽³⁾ ; KENT Jeffrey D. ⁽³⁾ ; RECKER David P. ⁽³⁾ ; VERBURG Kenneth M. ⁽³⁾ ;

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

⁽¹⁾ Division of Rheumatology, School of Medicine, University of South Florida, Tampa, Florida, ETATS-UNIS
⁽²⁾ Division of Gastroenterology, School of Medicine, Duke University, Durham, North Carolina, ETATS-UNIS
⁽³⁾ Global Clinical Research, Pharmacia Corporation, Skokie, Illinois, ETATS-UNIS

Résumé / Abstract

Objective To determine whether valdecoxib, at chronic arthritis doses, has the characteristics of a cyclooxygenase 2 (COX-2) specific inhibitor, as measured by a reduced incidence of upper-gastrointestinal ulceration compared with conventional nonsteroidal antiinflammatory drugs (NSAIDs). Methods This double-blind, multicentre, placebo-controlled, parallel-group study compared the incidence of gastroduodenal ulcers associated with valdecoxib 10 mg daily (q.d.) and 20 mg q.d. with that of ibuprofen 800 mg three times daily (ti.d.) or diclofenac 75 mg twice daily (b.i.d.) when administered over a 12-week period. The incidence of gastroduodenal ulcers was assessed by upper-gastrointestinal endoscopy, performed at baseline and again at the end of week 12 (or at early study termination). Efficacy assessments were performed at baseline and at weeks 2, 6 and 12 using Patient's and Physician's Global Assessments of Arthritis. Results A total of 1052 osteoarthritis patients were enrolled into the trial. The incidence of gastroduodenal ulcers over 12 weeks was 5% in patients receiving valdecoxib 10 mg q.d., 4% in patients receiving valdecoxib 20 mg q.d., 7% in patients receiving placebo, 16% in patients receiving ibuprofen 800 mg ti.d. (P< 0.05 v. placebo), and 17% in patients receiving diclofenac 75 mg b.i.d. (P< 0.05 v. placebo). The incidence of gastroduodenal ulcers at week 12 seen in the ibuprofen 800 mg t.i.d. and diclofenac 75 mg b.i.d. groups was significantly higher than that in the valdecoxib 10 mg q.d. and valdecoxib 20 mg q.d. groups (P< 0.05). The incidence rates of gastroduodenal ulcers were not significantly different between the valdecoxib treatment groups or between valdecoxib- and placebo-treated patients. Efficacy responses to valdecoxib 10 mg and 20 mg q.d. were significantly greater than placebo and comparable with both ibuprofen 800 mg t.i.d. and diclofenac 75 mg b.i.d. Conclusions The results of the study demonstrate that valdecoxib has an upper-gastrointestinal safety profile typical of a COX-2 specific inhibitor. Overall, the data indicate that administration of valdecoxib offers similar efficacy for the treatment of osteoarthritis but improved upper-gastrointestinal safety compared with the conventional NSAIDs, ibuprofen and diclofenac, based on the significantly lower incidence of gastroduodenal ulcers detected by endoscopy.

Revue / Journal Title

European journal of gastroenterology & hepatology   ISSN 0954-691X 

Source / Source

2002, vol. 14, n^o10, pp. 1101-1111 [11 page(s) (article)] (50 ref.)

Langue / Language

Anglais

Editeur / Publisher

Lippincott Williams & Wilkins, Hagerstown, MD, ETATS-UNIS  (1989) (Revue)

Mots-clés anglais / English Keywords

Intestinal disease ; Gastric disease ; Digestive diseases ; Degenerative disease ; Arthropathy ; Diseases of the osteoarticular system ; Arylpropionic acid derivatives ; Human ; Multicenter study ; Double blind study ; Clinical trial ; Complication ; Gastroduodenal ; Ulcer ; Incidence ; Diclofenac ; Ibuprofen ; Non steroidal antiinflammatory agent ; Inhibitor ; Valdecoxib ; Chemotherapy ; Treatment ; Osteoarthritis ;

Mots-clés français / French Keywords

Intestin pathologie ; Estomac pathologie ; Appareil digestif pathologie ; Maladie dégénérative ; Arthropathie ; Système ostéoarticulaire pathologie ; Cyclooxygénase COX2 ; Arylpropionique acide dérivé ; Homme ; Etude multicentrique ; Etude double insu ; Essai clinique ; Complication ; Gastroduodénal ; Ulcère ; Incidence ; Diclofénac ; Ibuprofène ; Antiinflammatoire non stéroïde ; Inhibiteur ; Valdécoxib ; Chimiothérapie ; Traitement ; Arthrose ;

Mots-clés espagnols / Spanish Keywords

Intestino patología ; Estómago patología ; Aparato digestivo patología ; Enfermedad degenerativa ; Artropatía ; Sistema osteoarticular patología ; Arilpropionico ácido derivado ; Hombre ; Estudio multicéntrico ; Estudio doble ciego ; Ensayo clínico ; Complicación ; Gastroduodenal ; Ulcera ; Incidencia ; Diclofenaco ; Ibuprofeno ; Antiinflamatorio no esteroide ; Inhibidor ; Valdecoxib ; Quimioterapia ; Tratamiento ; Artrosis ;

Localisation / Location

INIST-CNRS, Cote INIST : 22107, 35400010540129.0110