Clopidogrel Increases the Risk for Gastrointestinal Bleeding

Summary and Comment |
October 25, 2013

Clopidogrel Increases the Risk for Gastrointestinal Bleeding

  1. David J. Bjorkman, MD, MSPH (HSA), SM (Epid.)

Clopidogrel users in Taiwan had a threefold increased risk for hospitalization with upper or lower gastrointestinal bleeding compared with controls.

  1. David J. Bjorkman, MD, MSPH (HSA), SM (Epid.)

Clopidogrel is widely used to prevent vascular thrombotic events. However, the risk for upper gastrointestinal bleeding (UGIB) or lower bleeding (LGIB) may be increased by antithrombotic agents. To identify the frequency of and risk factors for gastrointestinal bleeding in clopidogrel users, investigators analyzed data from the National Health Insurance Research Database of Taiwan.

Researchers identified 3238 patients who took >150 doses (75 mg each) of clopidogrel during the 6 months prior to study enrollment. For each clopidogrel user, investigators identified four control patients matched by age, gender, and time of enrollment from a randomly sampled cohort of 1 million patients (total control patients, 12,952). Records were reviewed for a host of comorbidities and medication use. The endpoints were hospitalizations for UGIB and LGIB during the 10-year study period.

During a median follow-up of 1.3 years (range, <0.1–9.8) in the clopidogrel group, 3.8% of all study patients developed UGIB, and 2.7% developed LGIB. After adjusting for age, gender, comorbidities, and medication use, use of clopidogrel increased the risks for UGIB (hazard ratio, 3.66; 95% confidence interval, 2.96–4.51) and LGIB (HR, 3.52; 95% CI, 2.74–4.52). Increased age, chronic kidney disease (CKD), history of peptic ulcer bleeding (PUB), and use of aspirin or nonsteroidal anti-inflammatory drugs were independent risk factors for UGIB. Increased age, CKD, history of PUB, and use of aspirin or selective serotonin reuptake inhibitors were independent risk factors for LGIB.

Comment

The results from this large database study are limited by the absence of data on the use of proton-pump inhibitors, use of over-the-counter drugs, and Helicobacter pylori infection. The median duration of follow-up was also quite short, probably leading to an underestimate of bleeding risk for long-term clopidogrel users. Prospective trials using gastrointestinal bleeding endpoints are needed to address this issue.

Editor Disclosures at Time of Publication

  • Disclosures for David J. Bjorkman, MD, MSPH (HSA), SM (Epid.) at time of publication Leadership positions in professional societies World Gastroenterology Organization (Treasurer)

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