Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk: Insights From the FOURIER Trial
Open accessAbstract
Background: Lipoprotein(a) [Lp(a)] may play a causal role in atherosclerosis. PCSK9 (proprotein convertase subtilisin/kexin 9) inhibitors have been shown to significantly reduce plasma Lp(a) concentration. However, the relationship between Lp(a) levels, PCSK9 inhibition, and cardiovascular risk reduction remains undefined. Methods: Lp(a) was measured in 25 096 patients in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a randomized trial of evolocumab versus placebo in patients with established atherosclerotic cardiovascular disease (median follow-up, 2.2 years). Cox models were used to assess the independent prognostic value of Lp(a) and the efficacy of evolocumab for coronary risk reduction by baseline Lp(a) concentration. Results: The median (interquartile range) baseline Lp(a) concentration was 37 (13–165) nmol/L. In the placebo arm, patients with baseline Lp(a) in the highest quartile had a higher risk of coronary heart disease death, myocardial infarction, or urgent revascularization (adjusted hazard ratio quartile 4: quartile 1, 1.22; 95% CI, 1.01–1.48) independent of low-density lipoprotein cholesterol. At 48 weeks, evolocumab significantly reduced Lp(a) by a median (interquartile range) of 26.9% (6.2%–46.7%). The percent change in Lp(a) and low-density lipoprotein cholesterol at 48 weeks in patients taking evolocumab was moderately positively correlated ( r =0.37; 95% CI, 0.36–0.39; P <0.001). Evolocumab reduced the risk of coronary heart disease death, myocardial infarction, or urgent revascularization by 23% (hazard ratio, 0.77; 95% CI, 0.67–0.88) in patients with a baseline Lp(a) >median, and by 7% (hazard ratio, 0.93; 95% CI, 0.80–1.08; P interaction=0.07) in those ≤median. Coupled with the higher baseline risk, the absolute risk reductions, and number needed to treat over 3 years were 2.49% and 40 versus 0.95% and 105, respectively. Conclusions: Higher levels of Lp(a) are associated with an increased risk of cardiovascular events in patients with established cardiovascular disease irrespective of low-density lipoprotein cholesterol. Evolocumab significantly reduced Lp(a) levels, and patients with higher baseline Lp(a) levels experienced greater absolute reductions in Lp(a) and tended to derive greater coronary benefit from PCSK9 inhibition. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01764633.
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In the FOURIER trial, greater MACE reductions were seen among patients whose highly elevated Lp(a) levels were reduced by evolocumab.
“In the FOURIER trial, greater MACE reductions were seen among patients whose highly elevated Lp(a) levels were reduced by evolocumab [193].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [193]
The Abstract and ‘Effect of Evolocumab on Lp(a) Concentration’ section (pages not available) report that evolocumab lowered Lp(a) and that patients with higher baseline Lp(a) had greater absolute reductions and tended to have greater reductions in major coronary events. The claim overstates that qualified finding as a definite greater MACE reduction and describes the group as having ‘highly elevated’ Lp(a), although the main comparison was above versus at or below the median. (LLM, conf=0.85)
Experimental — accuracy not yet measuredPCSK9 inhibition with evolocumab provides a modest (16%) reduction in Lp(a) levels in patients with high Lp(a) levels.
“This finding has also been supported by randomised control trials which shown that PCSK9 inhibition with evolocumab provides modest (16%) reduction in Lp(a) levels in patients with high Lp(a) levels43.”
From Genetic insights into causal effects of lipids and lipid-modifying targets on calcific aortic valve stenosis: a Mendelian randomized study (2025) · cites this paper as [43]
The Abstract and “Effect of Evolocumab on Lp(a) Concentration” report that evolocumab lowered Lp(a), but the median reduction was 26.9% overall, not 16%. That section says percentage reductions decreased as baseline Lp(a) increased; its 16% figure refers to the overall reduction in major coronary events, not Lp(a) levels. (LLM, conf=0.91)
Experimental — accuracy not yet measuredThe net effect is a muted class response, with Lp(a) typically lowering around 20 to 30%, well below the reductions seen with LDL-C and ApoB.
“The net effect is a muted class response, with Lp(a) typically lowering around 20 to 30%, well below the reductions seen with LDL C and ApoB [25].”
From Oral PCSK9 inhibitors for elevated LDL-C: A systematic review and meta-analysis of randomized trials (2026) · cites this paper as [25]
The introduction reports that PCSK9 inhibitors reduced Lp(a) by approximately 25–30% in phase 2 trials, and the Effect of Evolocumab on Lp(a) Concentration section reports a median 26.9% reduction at 48 weeks. The paper discusses LDL-C changes but does not establish the claimed percentage-reduction comparison with both LDL-C and ApoB. (LLM, conf=0.85)
Experimental — accuracy not yet measuredRecent studies with PCSK9 inhibitors revealed that patients with higher baseline Lp(a) concentration experienced greater absolute reductions in Lp(a) and tended to derive greater clinical benefit from PCSK9 inhibition.
“Although recent studies with PCSK9 inhibitors were not designed to target patients with high Lp(a) concentrations, they nevertheless revealed that patients with higher baseline Lp(a) concentration experienced greater absolute reductions in Lp(a) and tended to derive greater clinical benefit from PCSK9 inhibition [27,28].”
From Quantifying atherogenic lipoproteins for lipid-lowering strategies: Consensus-based recommendations from EAS and EFLM (2020) · cites this paper as [27]
Evolocumab in FOURIER reduced Lp(a) by a median of 26.9% at 48 weeks, and alirocumab in ODYSSEY OUTCOMES showed a median relative reduction of −23% by 4 months.
“evolocumab in the FOURIER trial reduced Lp(a) by a median of 26.9% at 48 weeks[2,25], and alirocumab in ODYSSEY OUTCOMES showed a median relative reduction of −23% by 4 months[3,26].”
From Oral PCSK9 inhibitors for elevated LDL-C: A systematic review and meta-analysis of randomized trials (2026) · cites this paper as [25]
Mendelian randomization studies consistently show that lifelong exposure to higher Lp(a) levels is strongly and causally associated with increased atherosclerotic cardiovascular disease risk.
“In contrast, Mendelian randomization studies have consistently demonstrated that lifelong exposure to higher Lp(a) levels is strongly and causally associated with an increased risk of ASCVD [74,75].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [75]
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“In a post hoc regression-based analysis of the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial, which included patients in both the placebo and evolocumab groups, lipoprotein(a) concentration at week 12 of assigned treatment was associated with the subseque…”
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Atherosclerotic cardiovascular disease prevention in rheumatoid arthritis
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Effect of Pelacarsen on Lipoprotein(a) Cholesterol and Corrected Low-Density Lipoprotein Cholesterol
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Muvalaplin, an Oral Small Molecule Inhibitor of Lipoprotein(a) Formation
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“Although recent studies with PCSK9 inhibitors were not designed to target patients with high Lp(a) concentrations, they nevertheless revealed that patients with higher baseline Lp(a) concentration experienced greater absolute reductions in Lp(a) and tended to derive greater clinical benefit from PCSK9 inhibition [27,…”
BackgroundResultThe Evolving Understanding and Approach to Residual Cardiovascular Risk Management
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Lipoproteins and fatty acids in chronic kidney disease: molecular and metabolic alterations
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Lepodisiran — A Long-Duration Small Interfering RNA Targeting Lipoprotein(a)
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Lipoprotein(a) in Atherosclerotic Diseases: From Pathophysiology to Diagnosis and Treatment
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PoLA/CFPiP/PCS/PSLD/PSD/PSH guidelines on diagnosis and therapy of lipid disorders in Poland 2021
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Emerging RNA Therapeutics to Lower Blood Levels of Lp(a)
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Self-citationAncestry, Lipoprotein(a), and Cardiovascular Risk Thresholds
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Lipoprotein(a) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol
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Self-citationValue of Measuring Lipoprotein(a) During Cascade Testing for Familial Hypercholesterolemia
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“In a recent report from the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial, after LDL-cholesterol was lowered with evolocumab, Lp(a) remained a predictor of cardiovascular risk, with the lowest risk observed in patients with low LDL-cholesterol plus low Lp…”
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Self-citationFamilial hypercholesterolaemia: evolving knowledge for designing adaptive models of care
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Self-citationPCSK9 inhibition and inflammation: A narrative review
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Self-citationLipoprotein(a) Testing Trends in a Large Academic Health System in the United States
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Regulation of PCSK9 Expression and Function: Mechanisms and Therapeutic Implications
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Lipoprotein(a), Oxidized Phospholipids, and Coronary Artery Disease Severity and Outcomes
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“9 In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), which compared the PCSK9i alirocumab with placebo on a background of high-intensity or maximum-tolerated statin, baseline Lp(a) quartile strongly predicted risk of…”
Lipoprotein(a) as a Pharmacological Target: Premises, Promises, and Prospects
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“53,66 The greater Lp(a) lowering with these drugs in individuals with higher baseline Lp(a) seems to have a modest impact in terms of cardiovascular risk reduction, and the exact magnitude of such effects remains to be determined.”
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“bococizumab and alirocumab showed improved reduction of Lp(a) compared with statins [121, 134].”
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Self-citationEstablished and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention
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“In the FOURIER trial, greater MACE reductions were seen among patients whose highly elevated Lp(a) levels were reduced by evolocumab [193].”
BackgroundClinical Trial Design for Lipoprotein(a)-Lowering Therapies
Malick, W. A., Goonewardena, S. N., Köenig, W., & Rosenson, R. S. (2023) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2023.02.033 · Cited by 109 · see citing works
Lipoprotein(a) and Long-Term Cardiovascular Risk in a Multi-Ethnic Pooled Prospective Cohort
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“15,16 17–20 Moreover, lipid-lowering drugs reduce apoB to a lesser extent than LDL-C.”
Self-citationNovel and future lipid-modulating therapies for the prevention of cardiovascular disease
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PCSK9 Inhibition: From Current Advances to Evolving Future
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The PCSK9 revolution: Current status, controversies, and future directions
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Evidence of an anti-inflammatory effect of PCSK9 inhibitors within the human atherosclerotic plaque
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Lipoprotein(a)—The Crossroads of Atherosclerosis, Atherothrombosis and Inflammation
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“Evolocumab therapy in the first of these two trials, and alirocumab therapy in the second, reduced Lp(a) levels and cardiovascular disease risk independent of LDL cholesterol lowering [31,32].”
BackgroundResultInfluentialMenopause symptom management in women with dyslipidemias: An EMAS clinical guide
Anagnostis, P. G., Bitzer, J., Cano, A., Ceauşu, I., Chedraui, P. A., Durmuşoğlu, F., Erkkola, R., Goulis, D. G., Hirschberg, A. L., Kiesel, L., et al. (2020) · Maturitas · doi:10.1016/j.maturitas.2020.03.007 · Cited by 98 · see citing works
Pathophysiology of Aortic Stenosis and Future Perspectives for Medical Therapy
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Genetic and In Vitro Inhibition of PCSK9 and Calcific Aortic Valve Stenosis
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Diet and Lp(a): Does Dietary Change Modify Residual Cardiovascular Risk Conferred by Lp(a)?
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“A post hoc analysis of the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial demonstrated that evolocumab, a PCSK9 inhibitor, reduced Lp(a) in patients with established CVD by ~27% [70].”
BackgroundMethodLipoprotein(a) and Cardiovascular Disease in Chinese Population
Li, J., Ma, C.-S., Zhao, D. H., Yan, X.-W., Li, J., Ma, C., Zhao, D. H., Yan, X.-W., Ye, P., Chen, H., et al. (2022) · JACC Asia · doi:10.1016/j.jacasi.2022.08.015 · Cited by 94 · see citing works
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Lipoprotein(a) and Cardiovascular Diseases ― Revisited ―
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Lipoprotein apheresis for lipoprotein(a) and cardiovascular disease
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The dedicated “Lp(a) clinic”: A concept whose time has arrived?
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Self-citationPCSK9 Inhibition: Insights From Clinical Trials and Future Prospects
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Self-citationDyslipidemia Management in Adults With Diabetes
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Lipoprotein(a) in atherosclerosis: from pathophysiology to clinical relevance and treatment options
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“A post hoc analysis of the FOURIER trial also revealed an overall 16% risk reduction for major adverse cardiovascular events in patients treated with evolocumab, independent of LDL cholesterol lowering [81].”
BackgroundMethodExisting and emerging strategies to lower Lipoprotein(a)
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Highlighting Residual Atherosclerotic Cardiovascular Disease Risk
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“3) An unknown cause of ischemic stroke.(20,97,101,104) IIb C-LD”
BackgroundInfluentialLipoprotein(a): a genetic marker for cardiovascular disease and target for emerging therapies
Cesaro, A., Schiavo, A., Moscarella, E., Coletta, S., Conte, M., Gragnano, F., Fimiani, F., Monda, E., Caiazza, M., Limongelli, G., et al. (2020) · Journal of Cardiovascular Medicine · doi:10.2459/jcm.0000000000001077 · Cited by 84 · see citing works
Lipoprotein(a): Knowns, unknowns and uncertainties
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Computed tomographic angiography in coronary artery disease
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“…Elevated Risk) and ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trials showed that Lp(a) lowering by PCSK9 inhibitors was associated with a reduction in the rate of cardiovascular events in secondary prevention 69,70 .”
High lipoprotein(a): Actionable strategies for risk assessment and mitigation
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“Secondary analyses of the CV outcome trials, FOURIER and ODYS-SEY OUTCOMES, revealed that after lowering LDL-C with statins and anti-PCSK9 mAbs, high Lp(a) levels were associated with increased residual CVD risk [7,8].”
MethodAtar, D., Jukema, J. W., Molemans, B., Taub, P. R., Goto, S., Mach, F., Olmos, C. C., Underberg, J. A., KEECH, A. C., Tokgözoğlu, L. S., et al. (2021) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2020.12.013 · Cited by 78 · see citing works
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Advances in biological therapies for dyslipidemias and atherosclerosis
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Inclisiran: a novel agent for lowering apolipoprotein B–containing lipoproteins
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“C) which also enables correction of LDL-cholesterol (LDL-C) as standard methods for measuring LDL-C also include Lp(a)-”
BackgroundInfluentialFarmakis, I. T., Doundoulakis, I., Pagiantza, A., Zafeiropoulos, S., Antza, C., Karvounis, H. I., & Giannakoulas, G. A. (2020) · Journal of Cardiovascular Pharmacology · doi:10.1097/fjc.0000000000000963 · Cited by 64 · see citing works
- Authors
- O’Donoghue, M. L., Fazio, S., Giugliano, R. P., Stroes, E. S. G., Kanevsky, E., Gouni-Berthold, I., Im, K., Lira Pineda, A., Wasserman, S. M., Češka, R., Ezhov, M. V., Jukema, J. W., Jensen, H. K., Tokgözoğlu, S. L., Mach, F., Huber, K., Sever, P. S., Keech, A. C., Pedersen, T. R., & Sabatine, M. S.
- Affiliations
- Brigham and Women's Hospital (US)
- Oregon Health & Science University (US)
- Amsterdam UMC Location University of Amsterdam (NL)
- Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Germany (I.G.-B.).
- Amgen, Thousand Oaks, CA (A.L.P., S.M.W.).
- Amgen (United States) (US)
- Charles University (CZ)
- National Cardiology Research Center, Moscow, Russia (M.V.E.).
- Leiden University Medical Center (NL)
- Aarhus University (DK)
- Cardiovascular Division, Hacettepe University, Ankara, Turkey (S.L.T.).
- University of Geneva (CH)
- Sigmund Freud Privatuniversität Wien (AT)
- Imperial College London (GB)
- The University of Sydney (AU)
- Oslo University Hospital (NO)
- ORCID
- Venue
- Circulation
- Published
- 2019-03-19
- Volume
- 139
- Issue
- 12
- Pages
- 1483-1492
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2940327706
- Cited by
- 984
- References
- 33
- Citations by year
- 2026: 133 · 2025: 153 · 2024: 157 · 2023: 134 · 2022: 120 · 2021: 100 · 2020: 122 · 2019: 64 · 2018: 1
- FWCI
- 97.10
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Leiden Repository (Leiden University) (submittedVersion)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- Abbott Laboratories
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Brigham and Women's Hospital
- Gilead Sciences
- Alnylam Pharmaceuticals
- Univerzita Karlova v Praze
- Aarhus Universitet
- Aarhus Universitetshospital
- Regeneron Pharmaceuticals
- Intarcia Therapeutics
- Amarin Corporation
- Medicines Company
- Mylan
- MyoKardia
- Imperial College London
- Universiteit Leiden
- Daiichi-Sankyo
- Eisai
- Novo Nordisk
- Leids Universitair Medisch Centrum
- Universitetet i Oslo
- Hacettepe Üniversitesi
- Université de Genève
- Universität zu Köln
- Novo Nordisk Fonden (NNF18OC0031258)
- Servier
- Esperion Therapeutics
- Medical Research Council
- National Health and Medical Research Council
- Sydney Medical School
- Janssen Research and Development
- Daiichi Sankyo Europe
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Immunology and Microbiology › Immunology › Atherosclerosis and Cardiovascular Diseases
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- lipoprotein(a), PCSK9 inhibitors, evolocumab, cardiovascular risk, atherosclerotic cardiovascular disease, coronary artery disease, myocardial infarction, urgent revascularization, LDL cholesterol, prognostic factors, FOURIER trial, LDL cholesterol lowering
- MeSH terms
- Proprotein Convertase 9, Adult, Aged, Aged, 80 and over, Anticholesteremic Agents, Double-Blind Method, Female, Humans, Cholesterol, LDL, Male, Middle Aged, Risk Factors, Placebo Effect, Proportional Hazards Models, Treatment Outcome, Lipoprotein(a), Atherosclerosis, Antibodies, Monoclonal, Humanized
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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