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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]
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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]
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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]
In the citing paper
“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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“Firstly, in a prespecified analysis of the FOURIER trial that included 25,096 patients, evolocumab was associated with a reduction in cardiovascular events of 7% in patients with baseline Lp(a) lower that the median of 37 nmol/l versus 23% in patients with Lp(a) higher than the median [79].”
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“Although PCSK9 inhibitors and lipoprotein replacement can partially reduce LP(a) [108], there is still a lack of cost-effective drugs.”
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“64 Importantly, the reduction in MACE observed with evolocumab was consistent across ethnic groups, including Asians (HR, 0.79) and non-Asians (HR, 0.86), after adjusting for LDL-C changes.”
InfluentialYau, K., Cherney, D. Z. I., & Odutayo, A. (2025) · Diabetes Obesity and Metabolism · doi:10.1111/dom.70044 · Cited by 9
“36,37 Given the pro-thrombotic properties of Lp(a), aspirin may be considered in those with elevated Lp(a) although this has not been confirmed prospectively.”
Impact of PCSK9 inhibitors on lipoprotein(a) levels: a multi-centre study
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Self-citationDiretriz Brasileira de Dislipidemias e Prevenção da Aterosclerose – 2025
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“Notably, individuals with elevated Lp(a) may also derive greater benefit from PCSK9 inhibitors, which can further reduce LDL-C and overall ASCVD risk [16,17].”
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All we need to know about lipoprotein(a)
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“For the PCSK9 mAb trials [13], 38 treatment subgroups with ASCVD outcomes were identified from the FOURIER trial of evolocumab [20–26].”
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“The recent FOURIER and ODYSSEY Outcomes trials demonstrate that the reduction in Lp(a) could partly mediate the benefit of PCSK9mAb treatment in reducing ASCVD risk in high-risk patients, particularly in those with elevated Lp(a).(17,18,28) In the ODYSSEY trial, each 5 mg/dl reduction in Lp(a) with alirocumab was asso…”
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PCSK9 Monoclonal Antibodies Have Come a Long Way
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“PCSK9 inhibitors produce moderate but significant reductions in Lp(a) levels [42, 43] and it is likely that this contributes in part to the clinical benefits observed, at least in patients with elevated Lp(a) levels.”
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Lipoprotein (a) in primary cardiovascular disease prevention is actionable today
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The biology of lipoprotein(a): From genetics to molecular mechanisms
Atallah, Nasrallah, N., Harb, T., Gerstenblith, G., & Leucker, T. M. (2025) · European Journal of Clinical Investigation · doi:10.1111/eci.70133 · Cited by 9
“55,56 SR-B1, which typically mediates HDL cholesteryl ester uptake, is implicated in the hepatic uptake of Lp(a) as well.”
Atherosclerotic plaque, cardiovascular risk, and lipid-lowering strategies: a narrative review
Tam, F. C.-C., Lin, M.-G., Lam, T.-H., Tse, H.-F., & Wong, C. (2025) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2025.1659228 · Cited by 16
Emerging therapies targeting lipoprotein(a): the next frontier in cardiovascular risk reduction
Alhomoud, I. S. (2025) · Frontiers in Medicine · doi:10.3389/fmed.2025.1727918 · Cited by 10
Mulligan, M. D., Gandhi, R. S., Vishwakarma, R., & Bhattacharya, R. (2026) · Journal of clinical lipidology · doi:10.1016/j.jacl.2026.03.019 · Cited by 8
Hao, Y., Yang, Y., Wang, Y., & Li, J. (2022) · Current Medical Research and Opinion · doi:10.1080/03007995.2022.2078080 · Cited by 8
Considerations for routinely testing for high lipoprotein(a)
Nurmohamed, N. S., Moriarty, P. M., & Stroes, E. S. G. (2022) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000838 · Cited by 8
“In two posthoc analyses from the FOURIER and ODYSSEY OUTCOMES trials, it was shown that the absolute Lp (a) reduction achieved with PCSK9 inhibitors was an independent predictor of reduction in MACE [23,24].”
MethodSelf-citationIs a PCSK9 Inhibitor Right for Your Patient? A Review of Treatment Data for Individualized Therapy
Beltran, R. A., Zemeir, K., Kimberling, C. R., Kneer, M. S., Mifflin, M. D., & Broderick, T. L. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph192416899 · Cited by 9
Mickiewicz, A., Marlęga-Linert, J., Kuchta, A., Bachorski, W., Ćwiklińska, A., Raczak, G., Gruchała, M., & Fijałkowski, M. (2021) · Journal of Clinical Apheresis · doi:10.1002/jca.21872 · Cited by 8
“Conventional hypolipidemic agents, such as statins and ezetimibe, may even increase Lp(a) levels, and the impact of PCSK-9 (proprotein convertase subtilisin/kexin type 9) inhibitors on Lp(a) concentrations above 60 mg/dL is mild with a 14%-16% decrease.(11,12) Various selective extracorporeal methods of treatment have…”
BackgroundTargeting IL-6 in patients at high cardiovascular risk
Christoffersen, M., & Tybjaerg-Hansen, A. (2021) · The Lancet · doi:10.1016/s0140-6736(21)00985-5 · Cited by 8
Considerations for routinely testing for high Lp(a)
Nurmohamed, N. S., Moriarty, P. M., & Stroes, E. S. G. (2022) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000828 · Cited by 8
“In two post-hoc analyses from the FOURIER and ODYSSEY OUTCOMES trials, it was shown that the absolute Lp(a) reduction achieved with PCSK9 inhibitors was an independent predictor of reduction in MACE [23,24].”
MethodSelf-citationThe role of natural products as PCSK9 modulators: A review
Khayatan, D., Zare, K., Khanahmadi, M., Momtaz, S., Butler, A. E., Jamialahmadi, T., Almahmeed, W. A., Abdolghaffari, A. H., & Sahebkar, A. (2024) · Phytotherapy Research · doi:10.1002/ptr.8260 · Cited by 8
Metabolic effects of PCSK9 inhibition with Evolocumab in subjects with elevated Lp(a)
Zhang, X., Stiekema, L. C. A., Stroes, E. S. G., & Groen, A. K. (2020) · Lipids in Health and Disease · doi:10.1186/s12944-020-01280-0 · Cited by 9
“Epidemiological studies substantiated a markedly increased cardiovascular risk in subjects with elevated Lp(a), involving both pro-inflammatory as well as pro-coagulant effects [2].”
Self-citationHuang, Z., Yang, Y., Lü, J., Liang, J., He, Y., Yu, Y., Huang, H., Li, Q., Wang, B., Li, S., et al. (2021) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2021.747120 · Cited by 8
Pavlyha, M., Li, Y., Crook, S., Anderson, B. R., & Reyes‐Soffer, G. (2024) · Journal of clinical lipidology · doi:10.1016/j.jacl.2024.07.003 · Cited by 7
Emanuelsson, F., Jensen, J., Omar, M., Jürgens, M., Kistorp, C., Brandt, N., Møller, J. E., Schou, M., Bechmann, L. E., Larsen, E. L., et al. (2024) · Journal of clinical lipidology · doi:10.1016/j.jacl.2024.12.015 · Cited by 8
Akram, M. A., Khodja, A., Dalibalta, S., & Majdalawieh, A. F. (2025) · Current Medicinal Chemistry · doi:10.2174/0109298673348217241119063941 · Cited by 8
RNA Therapies in Cardio-Kidney-Metabolic Syndrome: Advancing Disease Management
Mohammadi, A., Karimian, A., Shokri, K., Mohammadi, A., Karzar, N. H., Bahar, R., Radfar, A., Pakyari, M., & Tehrani, B. N. (2025) · Journal of Cardiovascular Translational Research · doi:10.1007/s12265-025-10603-4 · Cited by 7
“PCSK9 inhibitors have shown a 23% reduction in cardiovascular events with Lp(a) lowering [34, 35].”
Lipoprotein(a) in clinical practice: Risk stratification and therapeutic strategies
Nasrallah, N., Atallah, Harb, T., Gerstenblith, G., & Leucker, T. M. (2025) · European Journal of Clinical Investigation · doi:10.1111/eci.70127 · Cited by 8
Innovations in Diagnosis and Treatment of Coronary Artery Disease
Agamy, S., Zaghloul, S., Khan, Z. U., Shahin, A., Kishk, R., Smman, A., & Candilio, L. (2025) · Diagnostics · doi:10.3390/diagnostics16010098 · Cited by 11
Proprotein convertase subtilisin/kexin Type 9 inhibitors: past, present, and future
Sabatine, M. S., & Laufs, U. (2026) · European Heart Journal · doi:10.1093/eurheartj/ehag148 · Cited by 7
Self-citationChong, T., Lan, N. S. R., Courtney, W., He, A., Strange, G. A., Playford, D. A., Dwivedi, G., Hillis, G. S., & Ihdayhid, A. R. (2023) · Cardiology in Review · doi:10.1097/crd.0000000000000528 · Cited by 7
Measuring lipoprotein(a) for cardiovascular disease prevention – in whom and when?
Thomas, P. E., Vedel‐Krogh, S., & Nordestgaard, B. G. (2023) · Current Opinion in Cardiology · doi:10.1097/hco.0000000000001104 · Cited by 8
“In the FOURIER trail, individuals with lipoprotein(a) levels above the median (37 nmol/l) had a 23% relative risk reduction of MACE, whereas individuals with lipoprotein(a) levels below the median had a nonsignificant risk reduction [67].”
BackgroundSzarek, M. J., Reijnders, E., Steg, P. G., Jukema, J. W., Schwertfeger, M., Bhatt, D. L., Bittner, V., Díaz, R., Fazio, S., Garon, G., et al. (2024) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwae110 · Cited by 7
Self-citationLp(a) Levels in Relatives of Patients with Acute Coronary Syndrome and Elevated Lp(a): HER(a) Study
Fernández-Olmo, M. R., Bailén, M. C., Quesada, M. M., Mansilla, C. R., Toro, M. M., Suárez, A. L., García, M. L., Quiroga, G. A. C., Bernal, B. C., Cruces, S. O., et al. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13082256 · Cited by 7
“…are currently being evaluated in randomized clinical trials, but PCSK9 inhibitors reduce Lp(a) by 25%, and subanalysis of the FOURIER trial [5] and the ODYSSEY Outcomes trial [6] demonstrated that patients with very high levels of Lp(a) obtained a significant benefit from the reduction in…”
BackgroundResultZhang, A. M. C., Ziogos, E., Harb, T., Gerstenblith, G., & Leucker, T. M. (2024) · European Journal of Clinical Investigation · doi:10.1111/eci.14272 · Cited by 7
“16,17 In both studies, a higher baseline Lp(a) concentration was independently associated with an increased risk of MACE.”
Strategies for management of patients with elevated lipoprotein(a)
Ellberg, C. C., & Bhatia, H. S. (2024) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000950 · Cited by 7
Yang, P., Tang, L., Guo, H., He, Y., Qin, Y., Yan, L., Li, Z., Guo, Y.-Z., & Wang, J. (2024) · Journal of Atherosclerosis and Thrombosis · doi:10.5551/jat.65214 · Cited by 9
Role of Lipoprotein(a) Reduction in Cardiovascular Disease
Schuth, U. H., Gill, K., Bawamia, B., Telyuk, P., Austin, D., & Zaman, A. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13216311 · Cited by 7
He, W., Zhao, H.-Y., Xue, W., Luo, Y., Yan, M., Li, J.-L., Qing, L.-J., Wu, W., & Jin, Z. (2024) · Drug Design, Development and Therapy · doi:10.2147/dddt.s487476 · Cited by 8
Duprez, D. A., Handelsman, Y., & Koren, M. J. (2020) · Vascular Health and Risk Management · doi:10.2147/vhrm.s261719 · Cited by 8
Kimura, T., Akahori, H., Tanaka, T., Yanaka, K., Yoshihara, N., Miki, K., Imanaka, T., Asakura, M., & Ishihara, M. (2022) · Journal of Cardiology · doi:10.1016/j.jjcc.2022.03.004 · Cited by 7
Dykun, I., Kampf, J., Rassaf, T., & Mahabadi, A. A. (2023) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwad059 · Cited by 7
Ups and downs in PCSK9 inhibition in the cardiovascular arena: a review
McClintick, D. J., & Giugliano, R. P. (2023) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000897 · Cited by 7
Self-citationGuijarro, C., & Camafort, M. (2019) · Revista Clínica Española · doi:10.1016/j.rce.2019.05.010 · Cited by 8
Heinrich, N. S., von Scholten, B. J., Reinhard, H., Persson, F., Ahluwalia, T. S., Hansen, T. W., Parving, H., Jacobsen, P. K., & Rossing, P. R. (2020) · Journal of Diabetes and its Complications · doi:10.1016/j.jdiacomp.2020.107593 · Cited by 7
Emerging Strategies for the Management of Atherogenic Dyslipidaemia
Agarwala, A., & Shapiro, M. D. (2020) · European Cardiology Review · doi:10.15420/ecr.2019.16 · Cited by 7
Wu, X.-D., Ye, X.-Y., Liu, X.-Y., Lin, Y., Lin, X. Y., Li, Y., Ye, B.-H., & Sun, J.-C. (2024) · Annals of Medicine · doi:10.1080/07853890.2024.2389470 · Cited by 8
“…can purportedly influence lipoprotein (a) biogenesis and clearance [43], which has been established as an independent risk factor associated with coronary, cerebrovascular, and peripheral artery diseases owing to its atherogenic, proinflammatory, and prothrombotic characteristics [44, 45].”
BackgroundPleiotropic Effects of PCSK9 Inhibitors on Cardio-Cerebrovascular Diseases
Li, Z., Zhu, L., Xu, Y., Zhang, Y., Liu, Y., Sun, H., Li, S., Wang, M., Jiang, T., Zhou, J., et al. (2024) · Biomedicines · doi:10.3390/biomedicines12122729 · Cited by 6
“PCSK9 also influences the metabolism of Lp(a), an independent risk factor for cardiovascular and cerebrovascular events [28].”
Akinlonu, A. A., Boffa, M. B., Lyu, C., Zhong, J., Jindal, M., Fadzan, M., Garshick, M. S., Schwartzbard, A. Z., WEINTRAUB, H. S., Bredefeld, C., et al. (2024) · Journal of clinical lipidology · doi:10.1016/j.jacl.2024.11.008 · Cited by 7
Sun, J., Liu, H.-R., Zhang, W., Shi, J., Wu, Q., Xu, R., & Zhu, Y. (2025) · Experimental and Therapeutic Medicine · doi:10.3892/etm.2025.12796 · Cited by 7
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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