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Upper gastrointestinal bleeding associated with NSAIDs, other drugs and interactions: a nested case-control study in
Francisco J de Abajo1, Miguel J Gil, Verónica Bryant
1BIFAP Research Unit, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices, Madrid, Spain. francisco.abajo@uah.es
European Journal of Clinical Pharmacology
|September 8, 2012
Summary
The study found non-steroidal anti-inflammatory drugs (NSAIDs) increase upper gastrointestinal bleeding (UGIB) risk, but less than previously thought. This drug safety issue appears to be decreasing over time.
Area of Science:
- Pharmacoepidemiology
- Drug Safety
- Gastroenterology
Background:
- Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly associated with upper gastrointestinal bleeding (UGIB).
- Assessing drug-associated risks requires robust research databases and methodologies.
Purpose of the Study:
- To evaluate the Spanish primary care research database (BIFAP) in capturing the association between UGIB and NSAIDs and other medications.
- To compare these findings with previous pharmacoepidemiological studies.
Main Methods:
- A nested case-control study was conducted using data from 2001-2005.
- Inclusion criteria: individuals aged 40-90 years.
- Statistical analysis involved unconditional logistic regression to calculate adjusted odds ratios.
Main Results:
- A cohort of 669,115 subjects yielded 1,193 incident UGIB cases.
- Increased UGIB risk was observed with NSAIDs, metamizole, low-dose aspirin, antiplatelet drugs, and oral anticoagulants.
- No increased risk was found for oral corticosteroids, SSRIs, or paracetamol. Acid-suppressing drugs mitigated NSAID-related risk.
Conclusions:
- The association between NSAIDs and UGIB risk is lower than previously reported, potentially due to methodological differences.
- A decreasing trend in the burden of NSAID-related UGIB over time is suggested.
- The BIFAP database is a valuable resource for pharmacoepidemiological research.
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