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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 [193].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [193]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“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]
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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 [27,28].”
From Quantifying atherogenic lipoproteins for lipid-lowering strategies: Consensus-based recommendations from EAS and EFLM (2020) · cites this paper as [27]
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“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]
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“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 addition to the effects on circulating LDL levels, the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial demonstrated that anti-PCSK9 could reduce Lp(a) concentration by ≈25% to 30%, and patients with higher baseline Lp(a) concentration may derive enhanced…”
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Unravelling lipoprotein metabolism with stable isotopes: tracing the flow
Ying, Q., Chan, D. C., Barrett, P. H. R., & Watts, G. F. (2021) · Metabolism · doi:10.1016/j.metabol.2021.154887 · Cited by 21
Krittanawong, C., Khawaja, M., Rosenson, R. S., Amos, C. I., Nambi, V., Lavie, C. J., & Virani, S. S. (2021) · Current Problems in Cardiology · doi:10.1016/j.cpcardiol.2021.101043 · Cited by 21
Puri, R., Mehta, V., Duell, P. B., Iyengar, S. S., Yusuf, J., Dalal, J., Narasingan, S. N., Kalra, D. K., Kapoor, A., Pradhan, A. K., et al. (2022) · Journal of clinical lipidology · doi:10.1016/j.jacl.2022.03.008 · Cited by 22
Lipoprotein (a) Levels and Abdominal Aortic Aneurysm. A Systematic Review and Meta-analysis
Oikonomou, E. K., Lampsas, S., Pantelidis, P., Theofilis, P., Grammatopoulos, K., Marathonitis, A., Vavuranakis, M., Siasos, G., Tousoulis, D., & Vavuranakis, Μ. (2022) · Current Pharmaceutical Design · doi:10.2174/1381612829666221124110920 · Cited by 23
Silverio, A., Cancro, F. P., Esposito, L., Bellino, M., D’Elia, D., Verdoia, M., Vassallo, M. G., Ciccarelli, M., Vecchione, C., Galasso, G., et al. (2023) · Journal of Clinical Medicine · doi:10.3390/jcm12062161 · Cited by 29
Shiyovich, A., Berman, A. N., Besser, S. A., Biery, D. W., Huck, D. M., Weber, B., Cannon, C. P., Januzzi, J. L., Booth, J. N., Nasir, K., et al. (2023) · European Heart Journal Open · doi:10.1093/ehjopen/oead077 · Cited by 22
Novel Therapies for Lipoprotein(a): Update in Cardiovascular Risk Estimation and Treatment
Wulff, A. B., Nordestgaard, B. G., & Langsted, A. (2024) · Current Atherosclerosis Reports · doi:10.1007/s11883-024-01192-9 · Cited by 23
Albuquerque, E. L., Fulco, U. L., Caetano, E. W. S., & Freire, V. N. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108774956.011 · Cited by 21
Sweeney, T. E., Quispe, R., Das, T. M., Juraschek, S. P., Martin, S. S., & Michos, E. D. (2021) · Expert Review of Precision Medicine and Drug Development · doi:10.1080/23808993.2021.1930531 · Cited by 24
Targeting PCSK9 With Antibodies and Gene Silencing to Reduce LDL Cholesterol
Newman, C. B., & Tobert, J. A. (2023) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgac708 · Cited by 20
Armario, P., Brotons, C., Elosúa, R., de Leciñana, M. A., Castro, A., Clarà, A. B. I., Cortés, O., Rodríguez, Á. D., Herranz, M., Justo, S., et al. (2021) · Clínica e Investigación en Arteriosclerosis (English Edition) · doi:10.1016/j.artere.2021.02.001 · Cited by 20
Rethinking cardiovascular risk: The emerging role of lipoprotein(a) screening
Clair, V., Zirille, F. M., & Gill, E. A. (2025) · American Journal of Preventive Cardiology · doi:10.1016/j.ajpc.2025.100945 · Cited by 21
“Additionally, evidence supports the use of PCSK9 inhibitors, which lower Lp(a) by approximately 25%, alongside their LDL-cholesterol-reducing effects, offering tangible benefits for high-risk individuals [22,23].”
Emerging Pharmacotherapy to Reduce Elevated Lipoprotein(a) Plasma Levels
Eraikhuemen, N. E., Lazaridis, D., & Dutton, M. T. (2020) · American Journal of Cardiovascular Drugs · doi:10.1007/s40256-020-00437-7 · Cited by 21
Therapeutic Apheresis for Management of Lp(a) Hyperlipoproteinemia
Pokrovsky, S. N., Afanasieva, O. I., & Владиславович, Е. М. (2020) · Current Atherosclerosis Reports · doi:10.1007/s11883-020-00886-0 · Cited by 21
Lipoprotein (a) and diabetes mellitus: causes and consequences
Ward, N. C., Vickneswaran, S., & Watts, G. F. (2020) · Current Opinion in Endocrinology Diabetes and Obesity · doi:10.1097/med.0000000000000597 · Cited by 21
Welsh, P. I., Welsh, C. E., Celis-Morales, C. A., Brown, R., Ferguson, L. D., Gray, S. R., Mark, P. B., Lewsey, J., Lyall, D. M., Gill, J. M. R., et al. (2020) · European Heart Journal · doi:10.1093/ehjci/ehaa946.2833 · Cited by 21
Umbrella Review on Non-Statin Lipid-Lowering Therapy
Beshir, S. A., Hussain, N., Elnour, A. A., & Said, A. S. A. (2021) · Journal of Cardiovascular Pharmacology and Therapeutics · doi:10.1177/10742484211002943 · Cited by 21
Oxidized phospholipids and lipoprotein(a): An update
Koutsogianni, A. D., Liberopoulos, E. N., Tellis, K., & Tselepis, A. D. (2021) · European Journal of Clinical Investigation · doi:10.1111/eci.13710 · Cited by 21
Review of recent clinical trials and their impact on the treatment of hypercholesterolemia
Parham, J. S., & Goldberg, A. C. (2022) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2022.11.011 · Cited by 22
Daring to dream: Targeting lipoprotein(a) as a causal and risk-enhancing factor
Koschinsky, M. L., Stroes, E. S. G., & Kronenberg, F. (2023) · Pharmacological Research · doi:10.1016/j.phrs.2023.106843 · Cited by 22
Self-citationLipoprotein(a): Expanding our knowledge of aortic valve narrowing
Youssef, A., Clark, J. R., Koschinsky, M. L., & Boffa, M. B. (2020) · Trends in Cardiovascular Medicine · doi:10.1016/j.tcm.2020.06.001 · Cited by 21
Yoon, D., Choi, B., Kim, J.-E., Kim, E., Chung, S.-H., Min, H.-J., Sung, Y., Chang, E., & Song, J. (2024) · BMC Medicine · doi:10.1186/s12916-024-03342-x · Cited by 21
“As PCSK9 inhibitors reduce LDL-cholesterol by 50 to 60% and Lp(a) by 20 to 30% [38–40], this raises the possibility that pharmacologic lipid-lowering therapy could offer a means to prevent or slow AS progression.”
BackgroundLp(a): A Rapidly Evolving Therapeutic Landscape
Anchouche, K., & Thanassoulis, G. (2024) · Current Atherosclerosis Reports · doi:10.1007/s11883-024-01252-0 · Cited by 22
“Subsequent analyses of this trial data showed that PCSK9 inhibitors reduce Lp(a) by up to 30%, and that among patients with high baseline Lp(a), this reduction contributed significantly to the observed decrease in MACE [21, 22 ] (Fig.”
PCSK9 Inhibitors: Focus on Evolocumab and Its Impact on Atherosclerosis Progression
Abduljabbar, M. H. (2024) · Pharmaceuticals · doi:10.3390/ph17121581 · Cited by 21
Lipoprotein(a) – From Biomarker to Therapy: A Review for the Clinician
Jha, M., Raber, I., & Gelfand, E. V. (2025) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2025.02.034 · Cited by 20
Pelacarsen: Mechanism of action and Lp(a)-lowering effect
Bhatia, H. S., Bajaj, A., Goonewardena, S. N., & Moriarty, P. M. (2025) · Journal of clinical lipidology · doi:10.1016/j.jacl.2025.06.004 · Cited by 25
The Inherited Hypercholesterolemias
Loh, W. J., & Watts, G. F. (2022) · Endocrinology and Metabolism Clinics of North America · doi:10.1016/j.ecl.2022.02.006 · Cited by 21
Palumbo, M., Giammanco, A., Purrello, F., Pavanello, C., Mombelli, G. G., Pino, A. D., Piro, S., Cefalu, A. B., Calabresi, L., Averna, M. R., et al. (2022) · Frontiers in Molecular Biosciences · doi:10.3389/fmolb.2022.925587 · Cited by 20
“Moreover, PCSK9-i treatment reduced lipoprotein (a) [Lp (a)] plasma levels (Kasichayanula et al., 2018; O’Donoghue et al., 2019), an atherogenic lipoprotein highly prone to oxidation and penetration through endothelia promoting the foam cell formation (Ugovšek and Šebeštjen, 2021).”
BackgroundTraditional risk factors, optimal cardiovascular health, and elevated lipoprotein(a)
Razavi, A. C., Reyes, M. P., Wilkins, J. T., Szklo, M., Tsai, M. Y., Whelton, S. P., Sperling, L. S., Tsimikas, S., & Bhatia, H. S. (2024) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwae382 · Cited by 20
Warden, B. A., Minnier, J., Watts, G. F., Fazio, S., & Shapiro, M. D. (2019) · Journal of clinical lipidology · doi:10.1016/j.jacl.2019.04.008 · Cited by 20
Self-citationLp(a): Addressing a Target for Cardiovascular Disease Prevention
Vasquez, N., & Joshi, P. H. (2019) · Current Cardiology Reports · doi:10.1007/s11886-019-1182-0 · Cited by 19
Lipoprotein (a): Underrecognized Risk with a Promising Future
Manzato, M., Wright, R. S., Jaffe, A. S., & Vasile, V. C. (2024) · Reviews in Cardiovascular Medicine · doi:10.31083/j.rcm2511393 · Cited by 19
Ballantyne, C. M., Gaudet, D., Rosenson, R. S., Hegele, R. A., Zhou, R., Melquist, S., Hellawell, J. L., & Leeper, N. J. (2025) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2025.03.496 · Cited by 20
Recomendaciones preventivas cardiovasculares. Actualización PAPPS 2020
Orozco‐Beltrán, D., Cuixart, C. B., Sánchez, J. J. A., Banegas, J. R., Cuenca, A. M. C., Gil-Guillén, V. F., Rioboó, E. M., & Pérez, J. N. (2020) · Atención Primaria · doi:10.1016/j.aprim.2020.08.002 · Cited by 24
Ying, Q., Chan, D. C., Pang, J., Marcovina, S. M., Barrett, P. H. R., & Watts, G. F. (2022) · Journal of Internal Medicine · doi:10.1111/joim.13457 · Cited by 19
Schwartz, G. G., & Giugliano, R. P. (2022) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000830 · Cited by 19
Self-citationHu, X., Cristino, J. R., Gautam, R., Mehta, R. K., Amari, D. T., Heo, J. H., Wang, S., & Wong, N. D. (2023) · American Journal of Preventive Cardiology · doi:10.1016/j.ajpc.2023.100476 · Cited by 18
Recent advances in the management and implementation of care for familial hypercholesterolaemia
Lan, N. S. R., Bajaj, A., Watts, G. F., & Cuchel, M. (2023) · Pharmacological Research · doi:10.1016/j.phrs.2023.106857 · Cited by 19
Prevalence of lipoprotein(a) measurement in patients with or at risk of cardiovascular disease
Panza, G. A., Blazek, O., Tortora, J., Saucier, S. J., & Fernández, A. B. (2023) · Journal of clinical lipidology · doi:10.1016/j.jacl.2023.09.016 · Cited by 19
Koskinas, K. C., Häner, J. D., Ueki, Y., Otsuka, T., Lønborg, J., Shibutani, H., Kakizaki, R., Kaiser, C. A., van Geuns, R., Ondracek, A. S., et al. (2024) · Circulation Cardiovascular Imaging · doi:10.1161/circimaging.124.016683 · Cited by 19
“16,17 The PACMAN-AMI trial (Effects of the PCSK9 Antibody Alirocumab on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction) found that the addition of the PCSK9 inhibitor alirocumab to high-intensity statin therapy resulted in greater coronary atheroma regression and…”
InfluentialSelf-citationLipoprotein(a) and Cardiovascular Disease Prevention across Diverse Populations
Pearson, K., & Rodríguez, F. (2020) · Cardiology and Therapy · doi:10.1007/s40119-020-00177-4 · Cited by 19
Berman, A. N., Biery, D. W., Ginder, C. R., Hulme, O. L., Marcusa, D. P., Leiva, O., Wu, W. Y., Singh, A., Divakaran, S., Hainer, J. M., et al. (2020) · Clinical Cardiology · doi:10.1002/clc.23456 · Cited by 18
Li, N., Zhou, J., Chen, R., Zhao, X., Li, J., Zhou, P., Liu, C., Chen, Y., Wang, Y., Song, L., et al. (2023) · Cardiovascular Diabetology · doi:10.1186/s12933-023-01881-w · Cited by 18
Wu, L., Zhang, B., Li, C., Zhuang, Z., Liu, K., Chen, H., Zhu, S., Zhu, J., Dai, Z., Huang, H., et al. (2024) · Journal of Neurology Neurosurgery & Psychiatry · doi:10.1136/jnnp-2023-332392 · Cited by 18
Metadata
- 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
- 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 › Cardiology and Cardiovascular Medicine › 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
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