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Association between venous thromboembolism events and fibrates: A comparative study
Charles Dolladille1, Xavier Humbert2, Murielle Faucon3
1Department of pharmacology, CHU de Caen, 14000 Caen, France; Department of cardiology, CHU de Caen, 14000 Caen, France.
Therapie
|November 29, 2018
Summary
Fibrates, particularly fenofibrate, are linked to an increased risk of venous thromboembolism (VTE) events in both diabetic and non-diabetic patients. This finding highlights potential safety concerns for these lipid-lowering drugs.
Area of Science:
- Pharmacovigilance and Pharmacoepidemiology
- Cardiovascular Risk and Thrombosis
- Metabolic Disorders and Drug Safety
Background:
- Previous research indicated a link between fibrates and venous thromboembolism (VTE) in diabetic patients with dyslipidemia, but findings in non-diabetic populations were inconsistent.
- Understanding the association between fibrate use and VTE is crucial for patient safety, especially given their widespread prescription for dyslipidemia.
Purpose of the Study:
- To investigate the association between fibrate medications and the occurrence of VTE events in both diabetic and non-diabetic individuals.
- To compare the risk of VTE associated with fibrate use across different patient populations.
Main Methods:
- A disproportionality analysis was conducted using the World Health Organization VigiBase® pharmacovigilance database to assess the reporting odds ratio (ROR) of VTE events associated with fibrates.
- A case-control study was performed using hospital data, comparing dyslipidemia patients hospitalized for VTE with matched controls hospitalized for non-VTE events.
- Multivariate conditional logistic regression was employed in the case-control study to adjust for potential confounding factors.
Main Results:
- The disproportionality analysis identified a significant association between fibrates and an increased reporting of VTE (ROR 1.14, CI 1.07-1.22).
- The case-control study revealed that fibrates were significantly associated with a higher risk of VTE requiring hospitalization (OR 3.67, CI 1.82-7.37).
- Fenofibrate was specifically identified as the fibrate associated with increased VTE risk in both analytical approaches.
Conclusions:
- Fenofibrate use is associated with a higher incidence of venous thromboembolism events.
- The association between fenofibrate and VTE risk is observed in both diabetic and non-diabetic patients.
- These findings underscore the importance of monitoring for VTE in patients prescribed fenofibrate.
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