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Cardioprotective aspirin users and their excess risk of upper gastrointestinal complications
Sonia Hernández-Díaz1, Luis A García Rodríguez
1Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA. shernan@hsph.harvard.edu
Insights
Low-dose aspirin increases upper gastrointestinal complications, particularly in older patients with a history of ulcers. Balancing aspirin
Area of Science:
- Pharmacovigilance
- Gastroenterology
- Cardiology
Background:
- Cardiovascular benefits of low-dose aspirin are well-established.
- Gastrointestinal (GI) harms of aspirin are a significant concern.
- Individual GI risk profiles are often overlooked when prescribing aspirin.
Purpose of the Study:
- To characterize the GI risk profile of low-dose aspirin users.
- To estimate the excess risk of upper GI complications attributable to aspirin based on GI risk factors.
Main Methods:
- Utilized The General Practice Research Database (UK) and Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (Spain).
- Characterized aspirin users by age, sex, prior ulcer history, and NSAID use.
- Employed meta-analyses to estimate baseline and excess GI complication risks.
Main Results:
- Over 60% of aspirin users are >60 years old; 4-6% have a recent ulcer history; >13% use other NSAIDs.
- Average excess upper GI risk from aspirin is ~5 cases/1,000 users/year.
- Excess risk exceeds 10 cases/1,000 person-years in >10% of users, correlating with underlying GI risk.
Conclusions:
- Gastrointestinal risk factors must be considered alongside cardiovascular risk for individual aspirin prescribing.
- High GI risk in patients with low cardiovascular risk may negate aspirin's benefits.
- Personalized risk-benefit assessment is crucial for safe aspirin use.
Background:
To balance the cardiovascular benefits from low-dose aspirin against the gastrointestinal harm caused, studies have considered the coronary heart disease risk for each individual but not their gastrointestinal risk profile. We characterized the gastrointestinal risk profile of low-dose aspirin users in real clinical practice, and estimated the excess risk of upper gastrointestinal complications attributable to aspirin among patients with different gastrointestinal risk profiles.
Methods:
To characterize aspirin users in terms of major gastrointestinal risk factors (i.e., advanced age, male sex, prior ulcer history and use of non-steroidal anti-inflammatory drugs), we used The General Practice Research Database in the United Kingdom and the Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria in Spain. To estimate the baseline risk of upper gastrointestinal complications according to major gastrointestinal risk factors and the excess risk attributable to aspirin within levels of these factors, we used previously published meta-analyses on both absolute and relative risks of upper gastrointestinal complications.
Results:
Over 60% of aspirin users are above 60 years of age, 4 to 6% have a recent history of peptic ulcers and over 13% use other non-steroidal anti-inflammatory drugs. The estimated average excess risk of upper gastrointestinal complications attributable to aspirin is around 5 extra cases per 1,000 aspirin users per year. However, the excess risk varies in parallel to the underlying gastrointestinal risk and might be above 10 extra cases per 1,000 person-years in over 10% of aspirin users.
Conclusion:
In addition to the cardiovascular risk, the underlying gastrointestinal risk factors have to be considered when balancing harms and benefits of aspirin use for an individual patient. The gastrointestinal harms may offset the cardiovascular benefits in certain groups of patients where the gastrointestinal risk is high and the cardiovascular risk is low.
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