Clinical Efficacy and Safety of Ezetimibe on Major Cardiovascular Endpoints: Systematic Review and Meta-Analysis of Randomized Controlled Trials
Open accessAbstract
BACKGROUND: Randomized clinical trials (RCTs) about Ezetimibe's efficacy on patient-oriented outcomes have given discordant results. The aim of this study was to determine the net effect of Ezetimibe and of the widely marketed combination, Ezetimibe+simvastatin, on mortality and morbidity outcomes. METHODS AND FINDINGS: We searched for RCT on Ezetimibe using MEDLINE, CCTR, EMBASE, ClinicalTrials.gov databases up to December 2013, Merck and Novartis online registers, and personal communications. Two authors independently selected trials fulfilling these criteria: RCTs comparing Ezetimibe±statin or another lipid-lowering drug against placebo, or against the same lipid-lowering drug at the same dosage, with a follow-up at least 24 weeks and one or more of these outcomes: all-cause mortality, cardiovascular (CV) mortality, stroke, myocardial infarction (MI), cancer, serious adverse events (SAEs); we assessed the risk of bias using the Cochrane checklist. We extracted the data for major clinical events as a dichotomous measure, with the patient the unit of analysis. Pooled analysis was done with random and fixed effect based models. Trials comparing Ezetimibe plus a lipid-lowering drug against the same lipidlowering drug representing the net effect of Ezetimibe, showed a nonsignificant tendency toward damage for cancer, MI, stroke and SAEs. Ezetimibe+simvastatin vs. simvastatin alone showed a stronger tendency towards a higher risk for all-cause death (2.52; 0.65-9.74), CV death (3.04; 0.48-19.21), non-CV death (3.03; 0.12-73.50), MI (1.91; 0.42-8.70), stroke (2.38; 0.46-12.35), cancer (RR 11.11; 0.62-198.29), and SAEs (1.45; 0.95-2.23). Limitations include small numbers of events and inadequate power of the pooling. Trials comparing Ezetimibe+simvastatin vs placebo showed non-significant effects: MI (0.81; 0.66-1.00 p = 0.051), all-cause death (1.02; 0.95-1.09), CV death (0.91; 0.80-1.04), non-CV death (108; 0.99-1.18), stroke (0.86; 0.72-1.04), cancer (1.18; 0.80-1.74), SAEs (1.01; 0.96-1.06). CONCLUSIONS: Ezetimibe±simvastatin had inconsistent effects on important outcomes. No firm conclusions are possible, but findings indicative of damage suggest much more selective use of Ezetimibe±simvastatin.
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The expected reductions of the intended combination of a Portfolio dietary pattern and NCEP Step II diet of ~27% (32% in efficacy and 15% in effectiveness trials) are similar to those seen with starting doses of low intensity statins (18 to 28%) or 10 mg of ezetimibe (15-20%).
“The expected reductions of the intended combination of a Portfolio dietary pattern and NCEP Step II diet of ~27% (32% in efficacy and 15% in effectiveness trials) are similar to those seen with the starting doses of low intensity statins (18 to 28%) 67 or 10 mg of ezetimibe (15-20%).69”
From Portfolio Dietary Pattern and Cardiovascular Disease: A Systematic Review and Meta-analysis of Controlled Trials (2018) · cites this paper as [69]
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- Authors
- Battaggia, A., Donzelli, A., Font, M., Molteni, D., & Galvano, A.
- Affiliations
- University of Milan (IT)
- University of Palermo (IT)
- Corresponding author
- Battaggia, Alessandro
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2015-04-27
- Volume
- 10
- Issue
- 4
- Pages
- e0124587
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC4411142
- OpenAlex
- W2091411838
- Cited by
- 36
- References
- 35
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 5 · 2023: 1 · 2022: 4 · 2021: 2 · 2020: 2 · 2019: 2 · 2018: 3 · 2017: 4 · 2016: 7 · 2015: 3
- FWCI
- 1.09
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- public-domain
- creativecommons.org/publicdomain/zero/1.0/ (vor)
- Locations
- PLoS ONE (publishedVersion, public-domain)
- PubMed Central (publishedVersion, public-domain)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- Nova Science Publishers (Nova Science Publishers, Inc.) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Keywords
- ezetimibe, ezetimibe-simvastatin combination, simvastatin, lipid-lowering therapy, cardiovascular mortality, myocardial infarction, stroke, cancer risk, serious adverse events, all-cause mortality, cardiovascular endpoints, drug safety, statins, hypercholesterolemia, dyslipidemia, risk of bias, treatment effect heterogeneity
- MeSH terms
- Ezetimibe, Aged, Anticholesteremic Agents, Cardiovascular Diseases, Cause of Death, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Comorbidity, Randomized Controlled Trials as Topic, Treatment Outcome, Simvastatin
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