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Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety
Prakriti Gaba1, Michelle L O'Donoghue1, Jeong-Gun Park1
1Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (P.G., M.L.O., J.-G.P., S.D.W., J.F.K., K.I., S.A.M., R.P.G., M.S.S.).
Circulation
|February 13, 2023
Summary
Achieving very low low-density lipoprotein cholesterol (LDL-C) levels, below 20 mg/dL, significantly reduces cardiovascular risk in patients with atherosclerotic cardiovascular disease. This extended study found no increased safety concerns with sustained LDL-C reduction.
Area of Science:
- Cardiology
- Clinical Research
- Pharmacology
Background:
- Low-density lipoprotein cholesterol (LDL-C) is a key risk factor for atherosclerotic cardiovascular disease (ASCVD).
- Optimal long-term LDL-C targets for efficacy and safety in ASCVD patients remain undetermined.
Purpose of the Study:
- To investigate the long-term relationship between achieved LDL-C levels and cardiovascular outcomes.
- To assess the safety of very low LDL-C levels in patients with established ASCVD.
Main Methods:
- Analysis of data from the FOURIER and its open-label extension (FOURIER-OLE) trial.
- Examined achieved LDL-C levels (<20, 20–<40, 40–<55, 55–<70, ≥70 mg/dL) and subsequent cardiovascular and safety outcomes.
- Utilized multivariable modeling to adjust for baseline factors and performed sensitivity analyses on the entire cohort.
Main Results:
- A monotonic decrease in cardiovascular events was observed with lower LDL-C levels, down to <20 mg/dL (adjusted P<0.0001).
- No statistically significant increased risk of major safety outcomes (e.g., cancer, stroke, diabetes, muscle events) was associated with lower LDL-C levels.
- Findings were consistent across the entire FOURIER and FOURIER-OLE population with up to 8.6 years of follow-up.
Conclusions:
- Sustained achievement of very low LDL-C levels (<20 mg/dL) is associated with reduced cardiovascular risk in ASCVD patients.
- No significant safety concerns were identified with long-term, very low LDL-C levels.
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