Statin Use and Gastrointestinal Hemorrhage: A Large Retrospective Cohort Study
Ashley I Martinez1, Patricia R Freeman1,2, Daniela C Moga3,4,5,6,7
1College of Pharmacy, University of Kentucky, Lexington, KY, USA.
Insights
Statin users face a higher risk of gastrointestinal hemorrhage, particularly within the first year of treatment. This increased risk, especially for severe bleeding events, is crucial for patient care.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Gastroenterology
Background:
- Cardiovascular disease affects many Americans, with statins being widely prescribed.
- Statins have known bleeding effects independent of cholesterol reduction.
- Existing literature presents conflicting data on statin use and gastrointestinal hemorrhage risk.
Purpose of the Study:
- To investigate the association between statin use and the risk of gastrointestinal hemorrhage.
- To quantify the risk of gastrointestinal hemorrhage in statin users compared to controls.
Main Methods:
- Retrospective cohort study utilizing the Truven Health MarketScan® Research Database (2009-2015).
- Included statin users and other chronic medication users aged 30-65 years.
- Followed participants for gastrointestinal hemorrhage events (inpatient and outpatient).
Main Results:
- Statin users exhibited an elevated risk of gastrointestinal hemorrhage (1-year adjusted HR 1.19).
- The risk of hospitalization due to gastrointestinal hemorrhage was higher (1-year adjusted HR 1.38).
- High-intensity statin users showed a greater incidence of gastrointestinal hemorrhage compared to moderate-intensity users.
Conclusions:
- Statin users demonstrated an increased risk of gastrointestinal hemorrhage compared to users of other chronic medications.
- Findings are significant for managing patients with pre-existing bleeding risks.
- Highlights the importance of considering gastrointestinal bleeding when prescribing statins.
Background:
Nearly 70% of Americans with cardiovascular disease use statins, which have documented bleeding effects independent of their cholesterol-lowering activities. However, the literature is conflicting regarding the association between statin use and gastrointestinal hemorrhage.
Objectives:
The aim of this study was to investigate the risk of gastrointestinal hemorrhage in statin users.
Methods:
In this retrospective cohort study, data from the Truven Health MarketScan® Research Database (2009-2015) were used to investigate the risk of gastrointestinal hemorrhage amongst statin users aged 30-65 years at the initial prescription claim. Statin users and a group of negative controls (i.e. other chronic medication users) were followed until first gastrointestinal hemorrhage event (both inpatient and outpatient, as well as restricted to inpatient), and were censored at treatment discontinuation, disenrollment from coverage, or the end of the study period.
Results:
Statin users had an elevated risk of gastrointestinal hemorrhage, which was especially apparent in the first year of treatment (1-year adjusted hazard ratio 1.19; 95% confidence interval (CI) 1.15-1.23). The risk of gastrointestinal hemorrhage leading to hospitalization was even higher (1-year adjusted hazard ratio 1.38; 95% CI 1.30-1.69). High-intensity statin users had a greater rate of gastrointestinal hemorrhage than moderate-intensity users (incidence rates per 1000 subject-years 22.2 (95% CI 21.9-22.8) vs. 21.5 (95% CI 21.3-21.8), respectively).
Conclusions:
In a population of commercially insured subjects aged 30-65 years, statin users had a higher risk for gastrointestinal hemorrhage than other chronic medication users. These findings are important when treating patients at a high risk for bleeding events.
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