Evacetrapib and cardiovascular outcomes in high-risk vascular disease
Open accessAbstract
BACKGROUND: The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease. METHODS: In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina. RESULTS: At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91). CONCLUSIONS: Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .).
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Early generations of CETP inhibitors were either associated with off-target adverse effects with safety concerns, or had no significant or only modest LDL-C lowering and thus failed to demonstrate cardiovascular benefit.
“Unfortunately, early generations of CETP inhibitors were either associated with off-target adverse effects with safety concerns, or had no significant or only modest LDL-C lowering and thus failed to demonstrate cardiovascular benefit, leading to a loss of enthusiasm in this drug class [[7], [8], [9], [10]].”
From Efficacy and safety of obicetrapib in patients with dyslipidemia: An updated meta-analysis of randomized controlled trials (2025) · cites this paper as [9]
The introduction (p. 1934) reports that torcetrapib was associated with suspected off-target toxicity and worse cardiovascular outcomes, while dalcetrapib had no effect on LDL cholesterol and did not reduce cardiovascular events. The paper does not say these results led to a loss of enthusiasm for CETP inhibitors. Its Discussion also reports that evacetrapib failed to improve outcomes despite substantial LDL-cholesterol lowering, so limited LDL lowering does not explain every failure it discusses. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThree large randomized controlled trials of cholesterol ester transfer protein inhibitors did not improve cardiovascular outcomes despite substantial increases in plasma HDL-C levels.
“three large RCTs of cholesterol ester transfer protein inhibitors (dalcetrapib, evacetrapib, and torcetrapib) did not improve CV outcomes despite substantial increases in plasma HDL-C levels”
From The Forgotten Lipids: Triglycerides, Remnant Cholesterol, and Atherosclerotic Cardiovascular Disease Risk (2019) · cites this paper as [22]
The observed annualized primary endpoint event rate for placebo patients in REDUCE-IT is consistent with historical cardiovascular outcome studies with comparable patient populations and expanded or hard MACE.
“The observed annualized primary endpoint event rate for placebo patients in REDUCE-IT was 5.74%, which is consistent with historical cardiovascular outcome studies, including those published since the design of REDUCE-IT, with comparable patient populations and expanded or hard major adverse cardiovascular events (MACE) (4,8,9,30-44).”
From Effects of Icosapent Ethyl on Total Ischemic Events (2019) · cites this paper as [36]
Mendelian randomization studies do not provide compelling evidence that HDL-C is causally associated with atherosclerotic cardiovascular disease risk.
“In contrast, Mendelian randomization studies do not provide compelling evidence that HDL-C is causally associated with the risk of ASCVD [49,61,62].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [62]
A meta-analysis of observational studies found that higher total cholesterol is associated with increased coronary artery disease mortality at all ages.
“A meta-analysis of observational studies has shown that higher TC is associated with increased CAD mortality at all ages [62,394].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [62]
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Research works printed but not linked: 3
- [2]2. Dr. Granger, receiving grant support from Armetheon, AstraZene- ca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi- Sankyo, GlaxoSmithKline, Janssen Pharmaceuticals, the Medi- cines Company, Medtronic Foundation, Novartis, and Pfizer, lecture fees and consulting fees from AstraZeneca, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi- Sankyo, Gilead Sciences, GlaxoSmithKline, Hoffmann-La Roche, Janssen Pharmaceuticals, the Medicines Company, Medtronic, Novartis, Pfizer, and Verseon, and lecture fees from Bayer; Dr. Montalescot, receiving grant support, to his institu- tion, from Association pour le Développement Industriel de la Réunion, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celladon, Daiichi-Sankyo, Eli Lilly, Insti- tute of Cardiometabolism and Nutrition, Fédération Française de Cardiologie, Medtronic, Merck Sharp and Dohme, Pfizer, Sanofi-Aventis, and the Medicines Company and consulting fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bris- tol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Merck Sharp and Dohme, Pfizer, Sanofi-Aventis, the Medicines Company, Berlin Chimie, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Cardiovascular Research Foundation, CME Resources, Europa, Elsevier, Fondazione Anna Maria Sechi per il Cuore, Gilead Sciences, Janssen, Lead-Up, Menarini, TIMI Study Group, and WebMD; Mr. Tall, receiving consulting fees from Merck, CSL Behring, and MedImmune; Ms. McErlean, receiving grant support from Eli Lilly and Pfizer; Dr. Ruotolo, being em- ployed by Eli Lilly; Dr. Vangerow, being employed by and owning equity or stock in Eli Lilly; Dr. Weerakkody, being employed by Eli Lilly; Dr. Goodman, receiving grant support, fees for serving on an advisory board, consulting fees, and lecture fees from Eli Lilly, Amgen, AstraZeneca, Bristol-Myers Squibb, Merck, Pfizer, and Sanofi-Regeneron;
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Kettunen, J., Holmes, M. V., Allara, E., Anufrieva, O., Ohukainen, P., Oliver-Williams, C., Wang, Q., Tillin, T., Hughes, A. D., Kähönen, M., et al. (2019) · PLOS Biology · doi:10.1371/journal.pbio.3000572 · Cited by 47 · see citing works
Causal Effect of Lipids and Lipoproteins on Atherosclerosis
Ference, B. A. (2018) · Cardiology Clinics · doi:10.1016/j.ccl.2017.12.001 · Cited by 28 · see citing works
Liao, P.-C., Chen, M.-S., Jhou, M.-J., Chen, T.-C., Yang, C.-T., & Lu, C.-J. (2022) · Diagnostics · doi:10.3390/diagnostics12081965 · Cited by 21 · see citing works
Yamashita, S., Okazaki, M., Okada, T., Masuda, D., Yokote, K., Arai, H., Araki, E., & Ishibashi, S. (2021) · Journal of Atherosclerosis and Thrombosis · doi:10.5551/jat.60764 · Cited by 14 · see citing works
Araújo, B., Arrighini, G. S., Queiroga, F., Mansouri, E. S., Rivera, A., Amador, W. F. O., Queiroz, I., Akabane, M. A. C. C., Consoli, L. N., Sobral, M. V. S., et al. (2025) · American Journal of Preventive Cardiology · doi:10.1016/j.ajpc.2025.101303 · Cited by 10 · see citing works
“Evacetrapib modestly reduced LDL-C, but its cardiovascular outcome trial was stopped early for futility due to limited statistical power [9].”
Ference, B. A. (2019) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1163 · Cited by 8 · see citing works
- Authors
- Lincoff, A. M., Nicholls, S. J., Riesmeyer, J. S., Barter, P. J., Brewer, H. B., Fox, K. A. A., Gibson, C. M., Granger, C., Menon, V., Montalescot, G., Rader, D., Tall, A. R., McErlean, E., Wolski, K., Ruotolo, G., Vangerow, B., Weerakkody, G., Goodman, S. G., Conde, D., McGuire, D. K., Nicolau, J. C., Leiva-Pons, J. L., Pesant, Y., Li, W., Kandath, D., Kouz, S., Tahirkheli, N., Mason, D., & Nissen, S. E.
- Affiliations
- Cleveland Clinic (US)
- ORCID
- Lincoff, A. Michael
- Nicholls, Stephen J.
- Fox, Keith A.A.
- Gibson, C. Michael
- Granger, Christopher
- Menon, Venu
- Montalescot, Gilles
- Rader, Daniel
- Tall, Alan R.
- Wolski, Kathy
- Ruotolo, Giacomo
- Weerakkody, Govinda
- Goodman, Shaun G.
- McGuire, Darren K.
- Leiva-Pons, Jose L.
- Li, Weimin
- Kouz, Simon
- Tahirkheli, Naeem
- Nissen, Steven E.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-05-18
- Volume
- 376
- Issue
- 20
- Pages
- 1933-1942
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2616536890
- Cited by
- 801
- References
- 34
- Citations by year
- 2026: 65 · 2025: 72 · 2024: 77 · 2023: 82 · 2022: 75 · 2021: 85 · 2020: 88 · 2019: 108 · 2018: 97 · 2017: 49 · 2015: 1 · 2014: 1
- FWCI
- 95.83
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Life Sciences › Immunology and Microbiology › Immunology › Atherosclerosis and Cardiovascular Diseases
- Keywords
- evacetrapib, cholesteryl ester transfer protein inhibitors, major adverse cardiovascular events, acute coronary syndrome, cerebral atherosclerosis, peripheral arterial disease, LDL cholesterol lowering, HDL cholesterol elevation, trial termination, cardiovascular risk reduction
- MeSH terms
- Aged, Anticholesteremic Agents, Benzodiazepines, Cardiovascular Diseases, Intracranial Arteriosclerosis, Diabetes Mellitus, Double-Blind Method, Female, Humans, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Risk, Biomarkers, Peripheral Vascular Diseases, Myocardial Ischemia, Treatment Failure, Cholesterol Ester Transfer Proteins
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.
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