Upper gastrointestinal bleeding associated with NSAIDs, other drugs and interactions: a nested case–control study in a new general practice database

Abstract

The increased risk of UGIB associated with NSAIDs was lower than previously reported, which could partly be explained by methodological differences, but a decreasing burden over time of this drug safety problem is suggested. BIFAP has shown to be a valuable tool for pharmacoepidemiological research.

Low-Dose Aspirin and Non-steroidal Anti-inflammatory Drugs Increase the Risk of Bleeding in Patients with Gastroduodenal Ulcer

“…In a Japanese retrospective case-control study by Sakamoto et al [5], the OR of upper GI bleeding was 5.5 for LDA and 6.1 for NSAIDs. However, it should be noted that in those case-control studies, the controls were selected from patients who were admitted during the same period or from population registries in the same district [3][4][5][8][9][10][11][12][13]. As a consequence, it remains unclear whether LDA and NSAIDs increase the risk of gastroduodenal mucosal lesions, the risk of bleeding from the mucosal lesions, or both.…”

Use of the i2b2 research query tool to conduct a matched case–control clinical research study: advantages, disadvantages and methodological considerations

“…The proportion and magnitude of chart review necessary for each study appears to vary based on the specific diagnoses/conditions of interest for each investigation. In a manner similar to our use of i2b2, de Abajo and colleagues used a primary care research database to identify patients with a condition of interest based on administrative coding, and then conducted chart review based on the initial query [7]. In their study, the investigators initially identified cases with a diagnosis of upper gastrointestinal (UGI) bleed based on International Classification of Primary Care Code or free text related to UGI bleed, which was screened via natural language processing.…”

MedDRA® automated term groupings using OntoADR: evaluation with upper gastrointestinal bleedings

“…'peptic ulcer' [28]) which are not specified as bleeding in MedDRA. Indeed one may observe gastric ulcers or gastric perforation that might not be associated with bleeding.…”

“…in the EU-ADR project [26] and reused in the Safety of Non-steroidal Anti-inflammatory Drugs (SOS) European project [27]. Whereas the MedDRA SMQ does not contain the 'Melena' and 'Hematemesis' PT, such terms were selected in studies focusing on UGIB [26,28] and we expect that addition of such terms might be desirable. But, contrary to these studies we chose to exclude from the UGIB grouping terms describing perforations (e.g.…”