Cardiovascular outcome trial · N Engl J Med 2019
REDUCE-IT trial
Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.
The bottom line
In statin-treated patients with elevated triglycerides, icosapent ethyl significantly reduced cardiovascular events including cardiovascular death, though at the cost of more atrial fibrillation hospitalizations and a trend toward more serious bleeding.
BenefitUS status: US-approved
At a glance
- Medicine
- 2 g of icosapent ethyl twice daily (total daily dose, 4 g)
- Compared with
- Placebo
- People
- 8,179
- Who took part
- Patients with established cardiovascular disease or with diabetes and other risk factors, receiving statin therapy, with fasting triglyceride level of 135 to 499 mg per deciliter and LDL-C level of 41 to 100 mg per deciliter (70.7% enrolled for secondary prevention)
- Design
- multicenter, randomized, double-blind, placebo-controlled trial
- Follow-up
- median of 4.9 years
- Main question
- Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina
Main result
A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001)
Effect on LDL cholesterol
''
Other results
Key secondary end point (cardiovascular death, nonfatal MI, or nonfatal stroke) rates were 11.2% and 14.8% (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001); cardiovascular death rate was 4.3% vs. 5.2% (hazard ratio, 0.80; 95% CI, 0.66 to 0.98; P=0.03)
Safety
A larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for atrial fibrillation or flutter (3.1% vs. 2.1%, P=0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06).
In the trial's own words
“A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001); the corresponding rates of the key secondary end point were 11.2% and 14.8% (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001).”
Quoted from the abstract of N Engl J Med 2019, checked word for word against PubMed. PubMed 30415628 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Icosapent ethyl (Vascepa)
Common questions
What did the REDUCE-IT trial find?
In statin-treated patients with elevated triglycerides, icosapent ethyl significantly reduced cardiovascular events including cardiovascular death, though at the cost of more atrial fibrillation hospitalizations and a trend toward more serious bleeding.
Who was in REDUCE-IT?
8,179 people. Patients with established cardiovascular disease or with diabetes and other risk factors, receiving statin therapy, with fasting triglyceride level of 135 to 499 mg per deciliter and LDL-C level of 41 to 100 mg per deciliter (70.7% enrolled for secondary prevention).
What was REDUCE-IT's main result?
A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001)
How much did LDL cholesterol change in REDUCE-IT?
''
Related trials
- VITAL (2019)Daily supplementation with 1 g marine omega-3 fatty acids did not reduce the incidence of major cardiovascular events or invasive cancer compared with placebo, though it was safe and reduced total myocardial infarction as a secondary finding.
- ASCEND (2018)In diabetic patients without known cardiovascular disease, daily 1-g omega-3 fatty acid supplementation did not reduce serious vascular events compared with placebo.
- STRENGTH (2020)In statin-treated high-risk patients, adding high-dose omega-3 carboxylic acids to usual therapy did not reduce major adverse cardiovascular events compared with corn oil and caused more GI side effects.
- PROMINENT (2022)In patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia, and low HDL/LDL cholesterol, pemafibrate lowered triglycerides and related lipid markers but did not reduce cardiovascular events compared with placebo and increased risks of renal events and venous thromboembolism.
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.