Cited by 205Lipoproteins and Cardiovascular HealthAcute Myocardial Infarction ResearchCancer, Lipids, and Metabolism

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Reduction in Total Cardiovascular Events With Ezetimibe/Simvastatin Post-Acute Coronary Syndrome

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Murphy, Sabina A., Cannon, Christopher P., Blazing, Michael A., Giugliano, Robert P., White, Jennifer A., Lokhnygina, Yuliya, Reist, Craig, Im, KyungAh, Bohula, Erin A., Isaza, Daniel, Lopez-Sendon, Jose, Dellborg, Mikael, Kher, Uma, Tershakovec, Andrew M., Braunwald, Eugene·2016·Journal of the American College of Cardiology

DOI 10.1016/j.jacc.2015.10.077

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Abstract

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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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: Murphy, Sabina A.
Cannon, Christopher P.
Giugliano, Robert P.
White, Jennifer A.
Bohula, Erin A.
Isaza, Daniel
Lopez-Sendon, Jose
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)
DOI: 10.1016/j.jacc.2015.10.077
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: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 367 d)
Locations: Journal of the American College of Cardiology (publishedVersion)
PubMed (publishedVersion)
Funders: GlaxoSmithKline
Amarin Corporation
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › 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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Reduction in Total Cardiovascular Events With Ezetimibe/Simvastatin Post-Acute Coronary Syndrome

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