Gastrointestinal events during treatment with nonsteroidal anti-inflammatory drugs (according to the data of the CONDOR study)

Abstract

The paper presents the results of a randomized double-blind study of the impact of therapy with celecoxib and a combination of diclofenac and omeprazole in patients with osteoarthrosis and rheumatoid arthritis on a risk for developing gastrointestinal diseases. The study was conducted at health care facilities in 196 centers of 32 countries and covered 18-to-60-year-old patients who belonged to an increased gastrointestinal risk group and had a history of gastroduodenal ulcers and a negative Helicobacter pylori test at screening. The included patients were randomized by a computer program in a 1: 1 ratio to treatment groups receiving celecoxib in a dose of 200 mg twice daily or sustained-release diclofenac 75 mg twice daily + omeprazole 20 mg once daily. The primary efficacy criterion was assessed as the development of clinically relevant changes in the upper or lower gastrointestinal tract (GIT). 4484 patients were randomized to treatment groups (2238 took celecoxib; 2246 received diclofenac + omeprazole). Twenty (0.9%) patients who took celecoxib and 81 (3.8%) who used diclofenac + omeprazole achieved the primary assessment criterion (p<0.0001). One hundred and fourteen (6%) patients who received celecoxib and 167 (8%) who took diclofenac + omeprazole were withdrawn from the study prematurely because of adverse reactions in the GIT (p = 0.0006). The risk of clinically relevant GIT changes was lower in the patients treated with celecoxib, that is a selective cyclooxygenase 2 (COX-2) inhibitor, than in the patients who received diclofenac, a nonselective COX inhibitor, and omeprazole, the proton pump inhibitor. The findings should contribute to the revision of approaches to reducing the gastrointestinal risk in nonsteroidal anti-inflammatory drugs treatment.

Keywords

• nonsteroidal anti-inflammatory drugs
• celecoxib
• diclofenac
• gastrointestinal events