Bempedoic Acid Linked to Lower Risk of Venous Thromboembolism: Study
A secondary analysis of the CLEAR Outcomes trial has found that bempedoic acid (Nexletol) was associated with a reduced risk of venous thromboembolism (VTE). The findings suggest that, in addition to its cholesterol-lowering benefits, bempedoic acid may provide added protection against blood clots in the veins. The study was published in JAMA Cardiology by Bernardo F. and colleagues.
In order to determine the effects of bempedoic acid on the incidence rates of thrombotic events in the long term, researchers examined the information from the CLEAR Outcomes trial that was a randomized, double-blinded, and placebo-controlled cardiovascular outcomes study. In this trial, the inclusion criteria included a vast population consisting of statin-intolerant patients aged between 18 and 85 years old who were considered to be at an extremely high risk of atherosclerotic cardiovascular disease or had already developed it.
Patient enrolment took place from December 22, 2016, to August 14, 2019, using 1250 medical centers spread across 32 countries. Participants were randomly allocated in a 1:1 ratio to treatment with bempedoic acid in an oral dosage of 180 mg per day and placebo. For the particular study on thrombosis, statistical analysis was to be performed during March 10, 2025, and February 19, 2026. The primary endpoint for this analysis included the time to the onset of a first verified composite event of VTE, which consisted of DVT and PE.
Key findings:
• The multi-center trial randomized an aggregate population of 13,970 high-risk participants, yielding a mean age of 65.5 years and a highly balanced gender distribution featuring 6740 female patients (48.2%).
• The large-scale cohort was divided evenly, with 6992 participants assigned to the active bempedoic acid arm and 6978 participants allocated to the placebo control arm.
• At the exact time of study randomisation, 275 participants (2.0%) had a documented history of VTE, and 1219 individuals (8.7%) were receiving active systemic anticoagulation.
• The research team followed up with the trial participants for a long-term median duration of 40.6 months, utilizing an interquartile range spanning from 37.1 to 46.2 months.
• A total of 106 VTE events occurred during follow-up, with only 39 events in the bempedoic acid group compared to 67 in the placebo group, showing a significant 42% risk reduction (Hazard Ratio [HR], 0.58; 95% Confidence Interval [CI], 0.39-0.86; P=.006).
• Findings remained highly consistent when looking specifically at deep vein thrombosis, showing a 44% drop with 39 events in total (HR, 0.56; 95% CI, 0.31-0.996; P=.045).
• The risk of life-threatening pulmonary embolism was also significantly lowered by 39%, according to independent secondary tracking (HR, 0.61; 95% CI, 0.37-0.996; P=.046).
In summary, use of bempedoic acid therapy on patients who had been classified as statin intolerant and were at high risk for or had pre-existing cardiovascular disease demonstrated a decreased risk of venous thromboembolism. The strong results obtained from the CLEAR Outcomes trial serve as a credible and promising outlook for contemporary vascular medicine, showing that newer non-statin strategies can afford potent antithrombotic benefits.
Reference:
Spiazzi BF, Brennan D, Zingano CP, et al. Bempedoic Acid and Venous Thromboembolism Risk Among Statin-Intolerant Patients: A Post Hoc Analysis of the CLEAR Outcomes Randomized Clinical Trial. JAMA Cardiol. Published online May 27, 2026. doi:10.1001/jamacardio.2026.1208
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