Key result
Warfarin exposure was associated with a higher risk of gastrointestinal bleeding compared to statins (HR 1.72) in the Taiwan Sentinel Data Model-formatted database.
Why the study?
The study investigated the feasibility of applying US FDA Sentinel System study designs, analytic choices, and routine querying tools to the Taiwan Sentinel Data Model-formatted National Health Insurance Research Database to examine drug-outcome associations.
Is it feasible to apply the US FDA Sentinel Routine Querying Tools to the Taiwan NHIRD to evaluate known drug safety signals?
Cohort (n=1,457,105)
Yes
Is it feasible to apply the US FDA Sentinel Routine Querying Tools to the Taiwan NHIRD to evaluate known drug safety signals?
Hazard Ratio: 1.72 (95% CI 1.5–1.98)
Absolute Event Rate: 25.59% vs 15.24%
Replicates known warfarin GI bleeding signal in Taiwan data; supports Sentinel tool feasibility but leaves practice change open.
The U.S. Food and Drug Administration's Sentinel System is a leading distributed data network for drug safety surveillance in the world. The National Health Insurance Research Database (NHIRD) in Taiwan was converted into the Taiwan Sentinel Data Model (TSDM) based on the Sentinel Common Data Model (SCDM) version 6.0.2. The goal of this study was to investigate the feasibility of applying the same study designs, analytic choices, and analytic tools as used by the U.S. Sentinel System to examine the same drug-outcome associations in the TSDM-formatted NHIRD. Four known drug-outcome associations previously examined by the U.S. Sentinel System were selected as the use cases: (1) use of angiotensin-converting enzyme inhibitors (ACEIs) and risk of angioedema, (2) use of warfarin and risk of gastrointestinal bleeding, (3) use of oral clindamycin and risk of Clostridioides difficile infection (CDI), and (4) use of glyburide and risk of serious hypoglycemia. We followed the same study designs and analytic choices used by the U.S. Sentinel System and applied the Sentinel Routine Querying Tools to answer the same study questions within the TSDM-formatted NHIRD. The results showed that ACEIs were associated with a non-significant increase in risk of angioedema compared to beta-blockers (hazard ratio [HR]: 1.21; 95% confidence interval [CI]: 0.89-1.64); warfarin was associated with a higher risk of gastrointestinal bleeding compared to statins (HR: 1.72; 1.50-1.98); glyburide was associated with an increased risk of hypoglycemia compared to glipizide (HR: 1.61, 1.30-2.00). We were unable to evaluate the association between oral clindamycin and risk of CDI due to the low event number. Our study demonstrated that it was feasible to directly apply the publicly available Sentinel Routine Querying Tools within the TSDM-formatted NHIRD. However, sources of heterogeneity other than design and analytic differences should be carefully considered when comparing the results between the two systems.
No takes yet. Share an insight, caveat, or question.
Lin et al. (2023) conducted a cohort in Indications for warfarin or statins (n=1,457,105). Warfarin vs. Statins was evaluated on Gastrointestinal bleeding (HR 1.72, 95% CI 1.50-1.98). Warfarin exposure was associated with a higher risk of gastrointestinal bleeding compared to statins (HR 1.72) in the Taiwan Sentinel Data Model-formatted database.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: