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.