SAT0085 Meloxicam has a low risk of serious gastrointestinal complications: pooled analysis of 27, 039 patients. (1st June 2001)

• Record Type: Journal Article
• Authors: Singh, G; Triadafilopoulos, G
• Is Part Of: Annals of the rheumatic diseases. Volume 60(2001)Supplement 1
• Page Start: A182
• Page End: A182
• Publication Date: 2001-06-01
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2001.460
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: Gastrointestinal (GI) complications are the most common adverse events associated with nonsteroidal anti-inflammatory drugs (NSAIDs). Although serious gastrointestinal complications, such as perforated ulcers and catastrophic bleeding, are uncommon, these events area. Objectives: We reviewed the incidence of serious upper GI (UGI) complications, including perforations, obstructions and hemodynamically-significant bleeds in a pooled data analysis of Meloxicam clinical trials that were at least 3 weeks in duration and included at least 20 patients per arm. Methods: Thirty-five trials with 27, 309 patients on Meloxicam, comparator NSAID?s, or placebo were included in the analysis. Nearly 39% (8109) patients were over age 65, and 1002 patients (4%) had a previous history of perforation, ulcer or bleed. Cases of suspected GI events were ascertained based on pre-defined criteria. Case report forms and supporting details were blinded and submitted to an independent Endpoint Committee for adjudication. Results: A total of 448 potential cases were identified and sent for adjudication. The Endpoint Committee determined that 54 of these cases met the predefined criteria for a clinically significant event. Conclusion: The risk of clinically significant UGI events with meloxicam is dose-dependent and low at the recommended doses of 7.5 mg and 15 mg.