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Risk factors of gastrointestinal bleeding in clopidogrel users: a nationwide population-based study
1Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
Insights
Clopidogrel use significantly increases the risk of upper and lower gastrointestinal bleeding. Key risk factors in users include age, chronic kidney disease, peptic ulcer bleeding history, and concurrent use of aspirin, NSAIDs, or SSRIs.
Area of Science:
- Cardiovascular Pharmacology
- Gastroenterology
- Clinical Epidemiology
Background:
- Gastrointestinal bleeding (GIB) is a significant concern in patients using antiplatelet medications.
- Risk factors for GIB specifically in clopidogrel users remain largely unidentified.
- Understanding these risks is crucial for patient safety and effective treatment strategies.
Purpose of the Study:
- To determine if clopidogrel is an independent risk factor for upper GIB (UGIB) and lower GIB (LGIB).
- To identify specific risk factors for UGIB and LGIB among clopidogrel users.
- To inform clinical practice regarding the safe use of clopidogrel.
Main Methods:
- A large-scale retrospective cohort study using Taiwan's National Health Insurance Research Database.
- 3,238 clopidogrel users were matched 1:4 with 12,952 controls based on age, sex, and enrollment time.
- Cox proportional hazard regression models were employed to analyze risk factors, adjusting for comorbidities and concomitant medications.
Main Results:
- Clopidogrel use was associated with a significantly increased risk of both UGIB (HR: 3.66) and LGIB (HR: 3.52).
- In clopidogrel users, independent risk factors for UGIB included older age, chronic kidney disease (CKD), peptic ulcer bleeding (PUB) history, and use of aspirin and NSAIDs.
- Independent risk factors for LGIB in clopidogrel users were older age, CKD, PUB history, and use of aspirin and SSRIs.
Conclusions:
- Clopidogrel is confirmed as an independent risk factor for both upper and lower gastrointestinal bleeding.
- Specific patient characteristics and concomitant medications (aspirin, NSAIDs, SSRIs) significantly elevate GIB risk in clopidogrel users.
- These findings highlight the need for careful patient selection and monitoring when prescribing clopidogrel, especially in those with pre-existing risk factors.
Background:
The risk factors for gastrointestinal bleeding (GIB) in clopidogrel users have not been identified.
Aim:
To clarify whether clopidogrel use is a risk factor for upper GIB (UGIB) and lower GIB (LGIB) and identify the risk factors in clopidogrel users.
Methods:
Using the National Health Insurance Research Database of Taiwan, 3238 clopidogrel users and 12,952 age-, sex-, and enrolment time-matched controls in a 1:4 ratio were extracted for comparison from a cohort dataset of 1,000,000 randomly sampled subjects. Cox proportional hazard regression models were used to identify the independent risk factors for UGIB and LGIB in all enrollees and clopidogrel users after adjustments for age, gender, comorbidity [i.e., coronary artery disease, hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease (CKD), cirrhosis, uncomplicated peptic ulcer disease, and peptic ulcer bleeding (PUB)], and medications [e.g., nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors, aspirin, steroids, selective serotonin reuptake inhibitors (SSRIs), warfarin and alendronate].
Results:
Cox proportional hazard regression analysis showed that use of clopidogrel increased the risk of UGIB [hazard ratio (HR): 3.66; 95% confidence interval (CI): 2.96-4.51] and LGIB [HR: 3.52, 95% CI: 2.74-4.52]. Age, CKD, PUB history, use of aspirin and NSAIDs were independent risk factors for UGIB in the clopidogrel users. Age, CKD, PUB history, use of aspirin and SSRIs were independent risk factors for LGIB.
Conclusions:
In clopidogrel users, age, CKD, PUB history, use of aspirin and NSAIDs are independent risk factors for UGIB; age, CKD, PUB history, use of aspirin and SSRIs are independent risk factors for LGIB.
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