Reduction in Total Cardiovascular Events With Ezetimibe/Simvastatin Post-Acute Coronary Syndrome
Open accessAbstract
Background Intensive low-density lipoprotein cholesterol therapy with ezetimibe/simvastatin in IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) significantly reduced the first primary endpoint (PEP) in patients post-acute coronary syndrome (ACS) compared to placebo/simvastatin.Objectives This analysis tested the hypothesis that total events, including those beyond the first event, would also be reduced with ezetimibe/simvastatin therapy.Methods All PEP events (cardiovascular [CV] death, myocardial infarction [MI], stroke, unstable angina [UA] leading to hospitalization, coronary revascularization ≥30 days post-randomization) during a median 6-year follow-up were analyzed in patients randomized to receive ezetimibe/simvastatin or placebo/simvastatin in IMPROVE-IT. Negative binomial regression was used for the primary analysis.Results Among 18,144 patients, there were 9,545 total PEP events (56% were first events and 44% subsequent events). Total PEP events were significantly reduced by 9% with ezetimibe/simvastatin vs placebo/simvastatin (incidence-rate ratio [RR]: 0.91; 95% confidence interval [CI]: 0.85 to 0.97; p = 0.007), as were the 3 pre-specified secondary composite endpoints and the exploratory composite endpoint of CV death, MI, or stroke (RR: 0.88; 95% CI: 0.81 to 0.96; p = 0.002). The reduction in total events was driven by decreases in total nonfatal MI (RR: 0.87; 95% CI: 0.79 to 0.96; p = 0.004) and total NF stroke (RR: 0.77; 95% CI: 0.65 to 0.93; p = 0.005).Conclusions Lipid-lowering therapy with ezetimibe plus simvastatin improved clinical outcomes. Reductions in total PEP events, driven by reductions in MI and stroke, more than doubled the number of events prevented compared with examining only the first event. These data support continuation of intensive combination lipid-lowering therapy after an initial CV event. (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial [IMPROVE-IT]; NCT00202878).
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Patients with elevated triglycerides, atherosclerosis, or diabetes receiving statins are at substantial risk for recurrent, potentially fatal ischemic events.
“In addition to their initial events, such patients are at substantial risk for recurrent, potentially fatal events.”
From Effects of Icosapent Ethyl on Total Ischemic Events (2019) · cites this paper as [10]
ASCEND found no significant impact on serious vascular events (HR 0.97, 95% CI 0.87-1.08) among 15,480 people randomized to omega-3 supplements versus placebo over a mean 7.4 years.
“Among 15 480 people randomized to omega-3 fatty acid supplements vs. placebo over a mean follow-up of 7.4 years, there was no significant effect (HR 0.97, 95% CI 0.87-1.08) on serious vascular events [nonfatal MI, non-fatal stroke, transient ischaemic attack (TIA), or vascular death] [329,424-426].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [424]
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Self-citation
- Authors
- Murphy, S. A., Cannon, C. P., Blazing, M. A., Giugliano, R. P., White, J. A., Lokhnygina, Y., Reist, C., Im, K., Bohula, E. A., Isaza, D., Lopez-Sendon, J., Dellborg, M., Kher, U., Tershakovec, A. M., & Braunwald, E.
- Affiliations
- Brigham and Women's Hospital (US)
- Duke University (US)
- Institute of Cardiology (CO)
- Hospital Universitario La Paz (ES)
- Sahlgrenska University Hospital (SE)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Corresponding author
- Murphy, Sabina A.
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2016-02
- Volume
- 67
- Issue
- 4
- Pages
- 353-361
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W2251889296
- Cited by
- 205
- References
- 25
- Citations by year
- 2026: 9 · 2025: 8 · 2024: 13 · 2023: 8 · 2022: 12 · 2021: 26 · 2020: 18 · 2019: 25 · 2018: 21 · 2017: 30 · 2016: 35
- FWCI
- 40.95
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- GlaxoSmithKline
- Amarin Corporation
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Keywords
- ezetimibe, simvastatin, ezetimibe/simvastatin, acute coronary syndrome, IMPROVE-IT trial, cardiovascular events, LDL cholesterol lowering, lipid-lowering therapy, myocardial infarction, stroke, cardiovascular mortality, secondary prevention, combination therapy, negative binomial regression, incidence rate ratio, coronary revascularization
- MeSH terms
- Ezetimibe, Aged, Anticholesteremic Agents, Dose-Response Relationship, Drug, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Cholesterol, LDL, Male, Middle Aged, Myocardial Infarction, Time Factors, United States, Incidence, Survival Rate, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Simvastatin, Acute Coronary Syndrome
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