Cardiovascular outcome trial · Circulation 2019
EWTOPIA 75 trial
Ezetimibe Lipid-Lowering Trial on Prevention of Atherosclerotic Cardiovascular Disease in 75 or Older (EWTOPIA 75): A Randomized, Controlled Trial.
The bottom line
In patients aged 75 or older with elevated LDL-C and no history of coronary disease, adding ezetimibe to usual care reduced cardiovascular events, though open-label design, early termination, and follow-up issues warrant cautious interpretation of the benefit's magnitude.
BenefitUS status: US-approved
At a glance
- Medicine
- Ezetimibe 10 mg once daily plus dietary counseling
- Compared with
- Usual care plus dietary counseling
- People
- 3,796
- Who took part
- Patients aged ≥75 years with elevated LDL-C without history of coronary artery disease, in Japan
- Design
- multicenter, prospective, randomized, open-label, blinded end-point evaluation
- Follow-up
- Median follow-up was 4.1 years
- Main question
- Composite of sudden cardiac death, myocardial infarction, coronary revascularization, or stroke
Main result
Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% CI, 0.50-0.86; P=0.002)
Other results
Composite cardiac events (HR, 0.60; 95% CI, 0.37-0.98; P=0.039) and coronary revascularization (HR, 0.38; 95% CI, 0.18-0.79; P=0.007) were lower in the ezetimibe group; no difference in incidence of stroke, all-cause mortality, or adverse events between trial groups
Safety
No difference in the incidence of ... adverse events between trial groups
In the trial's own words
“Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% CI, 0.50-0.86; P=0.002).”
Quoted from the abstract of Circulation 2019, checked word for word against PubMed. PubMed 31434507 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Ezetimibe (Zetia)
Common questions
What did the EWTOPIA 75 trial find?
In patients aged 75 or older with elevated LDL-C and no history of coronary disease, adding ezetimibe to usual care reduced cardiovascular events, though open-label design, early termination, and follow-up issues warrant cautious interpretation of the benefit's magnitude.
Who was in EWTOPIA 75?
3,796 people. Patients aged ≥75 years with elevated LDL-C without history of coronary artery disease, in Japan.
What was EWTOPIA 75's main result?
Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% CI, 0.50-0.86; P=0.002)
Related trials
- RACING (2022)In patients with atherosclerotic cardiovascular disease, moderate-intensity rosuvastatin plus ezetimibe was non-inferior to high-intensity rosuvastatin alone for 3-year cardiovascular outcomes, achieved more patients with LDL under 70 mg/dL, and caused less drug intolerance-related discontinuation or dose reduction.
- IMPROVE-IT (2015)Adding ezetimibe to statin therapy after acute coronary syndrome modestly reduces cardiovascular events beyond statin alone, with similar safety.
- SHARP (2011)In patients with moderate-to-severe chronic kidney disease, lowering LDL cholesterol with simvastatin plus ezetimibe safely reduced major atherosclerotic events compared with placebo.
- SEAS (2008)In patients with mild-to-moderate asymptomatic aortic stenosis, simvastatin plus ezetimibe did not reduce the composite of aortic-valve and ischemic cardiovascular events, though it reduced ischemic events alone and was associated with more cancer cases.
Get your LDL treated to a goal
Preval Health's protocols follow trials like this one. Licensed clinicians set your goal, prescribe and recheck until you reach it.
Get startedEducation only, not medical advice. Results describe the people in this trial and can differ for you. Talk with your clinician before starting or stopping any medicine. Back to all 106 trials.