Anti-PCSK9 Antibody Effectively Lowers Cholesterol in Patients With Statin Intolerance
Open accessAbstract
Objectives This study sought to evaluate the efficacy and safety of subcutaneous evolocumab compared with oral ezetimibe in hypercholesterolemic patients who are unable to tolerate effective statin doses.Background Statin intolerance, which is predominantly due to muscle-related side effects, is reported in up to 10% to 20% of patients. Evolocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), demonstrated marked reductions in plasma low-density lipoprotein cholesterol (LDL-C) in a phase 2 study in statin-intolerant patients.Methods The GAUSS-2 (Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects) trial was a 12-week, double-blind study of randomized patients (2:2:1:1) to evolocumab 140 mg every two weeks (Q2W) or evolocumab 420 mg once monthly (QM) both with daily oral placebo or subcutaneous placebo Q2W or QM both with daily oral ezetimibe 10 mg. Co-primary endpoints were percent change from baseline in LDL-C at the mean of weeks 10 and 12, and at week 12.Results Three hundred seven patients (age 62 ± 10 years; LDL-C 193 ± 59 mg/dl) were randomized. Evolocumab reduced LDL-C from baseline by 53% to 56%, corresponding to treatment differences versus ezetimibe of 37% to 39% (p <0.001). Muscle adverse events occurred in 12% of evolocumab-treated patients and 23% of ezetimibe-treated patients. Treatment-emergent adverse events and laboratory abnormalities were comparable across treatment groups.Conclusions Robust efficacy combined with favorable tolerability makes evolocumab a promising therapy for addressing the largely unmet clinical need in high-risk patients with elevated cholesterol who are statin intolerant. (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2; NCT01763905).
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Treatment with PCSK9 inhibitors reduces LDL-C by approximately -60%.
“Treatment with PCSK9 inhibitors reduces LDL-C by approximately − 60% [75–79].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [76]
The Efficacy outcomes section reports LDL-C reductions of 56.1% and 55.3% with evolocumab, reasonably close to approximately 60%. The trial studied one PCSK9 inhibitor in statin-intolerant patients, so it does not establish that magnitude for PCSK9 inhibitors generally. (LLM, conf=0.82)
Experimental — accuracy not yet measuredFewer musculoskeletal adverse effects occurred in those treated with evolocumab or ezetimibe than in those treated with ezetimibe plus placebo, although rates of discontinuation due to these effects were similar.
“Fewer musculoskeletal adverse effects occurred in those treated with evolocumab or ezetimibe than in those treated with ezetimibe plus placebo, although rates of discontinuation due to these effects were similar.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [136]
The Abstract reports fewer muscle adverse events with evolocumab than with ezetimibe (12% versus 23%), and the OTHER LIPIDS safety passage reports similar discontinuation rates due to musculoskeletal effects (5% versus 6%); page numbers are unavailable in our copy. But the Methods describe evolocumab plus oral placebo versus ezetimibe plus injected placebo, not evolocumab or ezetimibe versus ezetimibe plus placebo. The claim’s treatment comparison is therefore only partly supported. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn the GAUSS 1, 2, and 3 trials and OSLER, reductions in LDL cholesterol ranged from 55% and 56% for evolocumab biweekly and monthly plus daily oral placebo, respectively, to 19% and 16% for ezetimibe daily plus biweekly or monthly subcutaneous placebo, respectively.
“Reductions in LDL cholesterol ranged from 55% and 56% for evolocumab biweekly and monthly plus daily oral placebo, respectively, to 19% and 16% for ezetimibe daily plus biweekly or monthly subcutaneous placebo, respectively.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [136]
Table 2 reports the stated treatment arms and broadly similar LDL-C reductions in GAUSS-2, but the evolocumab figures are reversed: 56.1% for biweekly dosing and 55.3% for monthly dosing. It reports 19.2% and 16.6% for the corresponding ezetimibe arms; 16.6% would round to 17%, not 16%. This paper reports GAUSS-2, not results across GAUSS 1, 2, and 3 and OSLER. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn GAUSS/OSLER, reductions in LDL cholesterol ranged from 55% and 56% for evolocumab biweekly and monthly plus daily oral placebo, respectively, to 19% and 16% for ezetimibe daily plus biweekly or monthly subcutaneous placebo, respectively.
“Reductions in LDL cholesterol ranged from 55% and 56% for evolocumab biweekly and monthly plus daily oral placebo, respectively, to 19% and 16% for ezetimibe daily plus biweekly or monthly subcutaneous placebo, respectively.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [130]
Table 2 (Efficacy Outcomes; page not supplied) supports the treatment comparisons and approximately 19% LDL-C reduction for the biweekly-placebo ezetimibe group. But it reports 56.1% for biweekly evolocumab and 55.3% for monthly evolocumab—the reverse of the cited sentence—and 16.6%, not 16%, for the monthly-placebo ezetimibe group. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn GAUSS/OSLER, fewer musculoskeletal adverse effects occurred in those treated with evolocumab or ezetimibe than in those treated with ezetimibe plus placebo, although rates of discontinuation due to these effects were similar.
“Fewer musculoskeletal adverse effects occurred in those treated with evolocumab or ezetimibe than in those treated with ezetimibe plus placebo, although rates of discontinuation due to these effects were similar.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [130]
The GAUSS-2 Results report fewer muscle adverse events with evolocumab than with ezetimibe (12% versus 23%) and similar discontinuation rates due to musculoskeletal effects (5% versus 6%). They do not support the claim that ezetimibe had fewer such effects than “ezetimibe plus placebo”: the ezetimibe group received placebo injections. This paper reports GAUSS-2, not OSLER. (LLM, conf=0.88)
Experimental — accuracy not yet measured
Use of low-dose statins was allowed in these studies and was associated with an increase in the incidence of musculoskeletal adverse effects.
“Use of low-dose statins was allowed in these studies and was associated with an increase in the incidence of musculoskeletal adverse effects (135,136).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [136]
Use of low-dose statins was allowed in these studies and was associated with an increase in the incidence of musculoskeletal adverse effects.
“Use of low-dose statins was allowed in these studies and was associated with an increase in the incidence of musculoskeletal adverse effects (129,130).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [130]
A fat-modified diet providing 25-40 g per day of total dietary fibre, including at least 7-13 g of soluble fibre, is well tolerated and effective for plasma lipid control.
“A fat-modified diet that provides 25-40 g per day of total dietary fibre, including ≥7-13 g of soluble fibre, is well tolerated, effective, and recommended for plasma lipid control”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [182]
PCSK9 inhibitors reduce LDL-C by 50-60% in a variety of patient groups, including those identified as statin intolerant.
“Studies have consistently shown large LDL-C reductions of 50–60% in a variety of patient groups,64,65 including those identified as statin intolerant,66–68”
PCSK9 inhibitors have a very low rate of muscle symptoms.
“with a very low rate of muscle symptoms”
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Arunsak, B., Pratchayasakul, W., Amput, P., Chattipakorn, K., Tosukhowong, T., Kerdphoo, S., Jaiwongkum, T., Thonusin, C., Palee, S., Chattipakorn, N., et al. (2020) · Archives of Biochemistry and Biophysics · doi:10.1016/j.abb.2020.108470 · Cited by 19 · see citing works
- Authors
- Stroes, E., Colquhoun, D., Sullivan, D., Civeira, F., Rosenson, R. S., Watts, G. F., Bruckert, E., Cho, L., Dent, R., Knusel, B., Xue, A., Scott, R., Wasserman, S. M., & Rocco, M.
- Affiliations
- Amsterdam UMC Location University of Amsterdam (NL)
- Wesley Long Hospital (US)
- Royal Prince Alfred Hospital (AU)
- Hospital Universitario Miguel Servet (ES)
- Icahn School of Medicine at Mount Sinai (US)
- The University of Western Australia (AU)
- Cleveland Clinic (US)
- Amgen (United States) (US)
- Corresponding author
- Stroes, Erik
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2014-06
- Volume
- 63
- Issue
- 23
- Pages
- 2541-2548
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W121888607
- Cited by
- 526
- References
- 26
- Citations by year
- 2026: 8 · 2025: 17 · 2024: 26 · 2023: 33 · 2022: 21 · 2021: 20 · 2020: 38 · 2019: 43 · 2018: 40 · 2017: 69 · 2016: 98 · 2015: 85 · 2014: 27 · 2013: 1
- FWCI
- 92.16
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Amgen Inc
- Amgen, Abbott Products, AstraZeneca, Merck, Sharp, and Dohme, and sanofi-aventis
- Abbott Products, AstraZeneca, Merck, Sharp, and Dohme, Pfizer Australia, and Roche
- Merck
- Amgen, Novartis, and sanofi-aventis
- Amgen and Eli Lilly
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- evolocumab, ezetimibe, statin intolerance, PCSK9 inhibition, LDL cholesterol lowering, hypercholesterolemia, monoclonal antibodies, lipid-lowering therapy
- MeSH terms
- Proprotein Convertase 9, Adolescent, Adult, Aged, Antibodies, Monoclonal, Cholesterol, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Drug Tolerance, Female, Follow-Up Studies, Humans, Hypercholesterolemia, Male, Serine Endopeptidases, Treatment Outcome, Apoptosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Proprotein Convertases, Young Adult, Antibodies, Monoclonal, Humanized
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