An evidence-based evaluation of the gastrointestinal safety of coxibs
Abstract
Nonsteroidal anti-inflammatory drugs (NSAIDs) are nonselective inhibitors of cyclooxygenase (COX) isoforms COX-1 and COX-2. NSAIDs have analgesic and anti-inflammatory properties that are proven, and they are extensively used in the treatment of arthritis, pain, and headache. Despite their good efficacy, NSAIDs are associated with significant gastrointestinal (GI) toxicity, which appears to be related to the inhibition of the cytoprotective function of COX-1. Thus, selective COX-2 inhibitors, or coxibs, were designed to inhibit only the production of COX-2-dependent inflammatory prostaglandins, without any effect on COX-1 and its gastroprotective function. This article reviews important evidence on the GI safety of coxibs. Endoscopic studies demonstrated that coxibs, such as celecoxib and rofecoxib, induced significantly fewer ulcers than nonspecific NSAIDs. To analyze whether the incidence of clinical GI events is also lower with coxibs, 2 large controlled clinical trials, the Celecoxib Long-term Arthritis Safety Study (CLASS) and Vioxx Gastrointestinal Outcomes Research (VIGOR), evaluated the GI safety of celecoxib and rofecoxib, respectively. Based on evidence from the VIGOR trial, it was demonstrated that rofecoxib has already fulfilled the promise and significantly decreases the risk of clinically important and complicated GI events compared with a nonselective NSAID, naproxen. In contrast, the CLASS trial showed that the incidence of ulcer complications in patients…
Read the paper
Related studies
- Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial
- Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease
- Human Leukocyte Antigen Complex and Other Immunogenetic and Clinical Factors Influence Susceptibility or Protection to SARS-CoV-2 Infection and Severity of the Disease Course. The Sardinian Experience
- Celecoxib or naproxen treatment does not benefit depressive symptoms in persons aged 70 and over: findings from a randomized controlled trial
- Comparative Clinical Effectiveness of Nonsurgical Treatment Methods in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial
- Efficacy and safety of adalimumab by intra-articular injection for moderate to severe knee osteoarthritis: An open-label randomized controlled trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.