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Potential Cardiovascular Events Avoided with Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared with
R Brett McQueen1, Seth J Baum2, Michael J Louie3
1Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Mail Stop C238, 12850 E. Montview Blvd, Aurora, CO, 80045, USA. robert.mcqueen@cuanschutz.edu.
Insights
Adding bempedoic acid plus ezetimibe fixed-dose combination (BA+EZE FDC) to statins can reduce cardiovascular events compared to ezetimibe alone. The benefits are greater for patients with higher baseline LDL-C levels.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Health Economics
Background:
- Atherosclerotic cardiovascular disease (ASCVD) patients on statins often have unmet needs for further LDL-C lowering.
- These patients face increased risks of cardiovascular events and reduced quality of life.
Purpose of the Study:
- To estimate cardiovascular events avoided with bempedoic acid plus ezetimibe fixed-dose combination (BA+EZE FDC) versus ezetimibe (EZE).
- To compare BA+EZE FDC vs. EZE in ASCVD patients on maximally tolerated statins across various baseline LDL-C levels.
Main Methods:
- A Markov cohort simulation model estimated major adverse cardiovascular events (MACE) avoided over a lifetime.
- BA+EZE FDC was compared to EZE based on LDL-C reductions from a phase III trial.
- Outcomes were extrapolated to a US population using NHANES data.
Main Results:
- BA+EZE FDC demonstrated incremental reductions in MACE compared to EZE in ASCVD patients.
- For baseline LDL-C 101-110 mg/dL, 4.9% fewer events were predicted with BA+EZE FDC.
- For baseline LDL-C >200 mg/dL, 10.9% fewer events were predicted with BA+EZE FDC.
Conclusions:
- Adding BA+EZE FDC to statins is predicted to reduce MACE more than adding EZE.
- The benefits of BA+EZE FDC are potentially greater for patients with higher baseline LDL-C levels.
Background:
Patients with atherosclerotic cardiovascular disease who require additional low-density lipoprotein cholesterol (LDL-C) lowering despite maximally tolerated statins have a significant unmet medical need and are at increased risk of future cardiovascular events and a reduced quality of life.
Objective:
We aimed to estimate the percentage of cardiovascular events avoided following treatment with a fixed-dose combination of bempedoic acid plus ezetimibe (BA+EZE FDC) versus ezetimibe (EZE) in patients with atherosclerotic cardiovascular disease receiving maximally tolerated statins across a range of baseline LDL-C levels.
Methods:
A Markov cohort simulation model estimated major adverse cardiovascular events avoided over a lifetime horizon among patients with atherosclerotic cardiovascular disease and baseline LDL-C levels from 80 to >200 mg/dL. BA+EZE FDC was compared with EZE based on mean percent LDL-C reductions versus placebo reported in a phase III trial. Health outcomes for the average patient were extrapolated to a US population of 100,000 persons using evidence on contemporary LDL-C levels from the National Health and Nutrition Examination Survey.
Results:
Among patients with atherosclerotic cardiovascular disease not at the LDL-C goal with maximally tolerated statins, the addition of BA+EZE FDC compared with the addition of EZE was predicted to provide incremental absolute reductions in major adverse cardiovascular events dependent on baseline LDL-C levels at the population level. For those with baseline LDL-C of 101-110 mg/dL (n = 15,237), there were 4.9% (744) fewer events predicted, while for patients with baseline LDL-C of > 200 mg/dL (n = 1689), 10.9% (184) fewer events were predicted through the addition of BA+EZE FDC versus EZE.
Conclusions:
Further LDL-C reductions through the addition of BA+EZE FDC to maximally tolerated statins are predicted to reduce major adverse cardiovascular events compared with the addition of EZE. Benefits are potentially greater among those with higher starting LDL-C.
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