Cardiovascular outcome trial · JAMA 2020
STRENGTH trial
Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial.
The bottom line
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.
No significant benefitUS status: FDA-approved for TG (not marketed)
At a glance
- Medicine
- 4 g/d omega-3 carboxylic acids (EPA and DHA formulation) (n=6539)
- Compared with
- Corn oil, intended as inert comparator (n=6539)
- People
- 13,078
- Who took part
- Statin-treated participants with high cardiovascular risk, hypertriglyceridemia, and low HDL-C (mean age 62.5 years; 35% women; 70% with diabetes; median LDL 75.0 mg/dL; median triglycerides 240 mg/dL; median HDL-C 36 mg/dL; median hs-CRP 2.1 mg/L)
- Design
- double-blind, randomized, multicenter trial
- Follow-up
- Enrollment October 30, 2014, to June 14, 2017; trial terminated January 8, 2020; last patient visit May 14, 2020
- Main question
- Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization
Main result
The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84)
Effect on LDL cholesterol
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Other results
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Safety
A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).
In the trial's own words
“The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84).”
Quoted from the abstract of JAMA 2020, checked word for word against PubMed. PubMed 33190147 · Full paper (DOI)
Common questions
What did the STRENGTH trial find?
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.
Who was in STRENGTH?
13,078 people. Statin-treated participants with high cardiovascular risk, hypertriglyceridemia, and low HDL-C (mean age 62.5 years; 35% women; 70% with diabetes; median LDL 75.0 mg/dL; median triglycerides 240 mg/dL; median HDL-C 36 mg/dL; median hs-CRP 2.1 mg/L).
What was STRENGTH's main result?
The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84)
How much did LDL cholesterol change in STRENGTH?
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Related trials
- REDUCE-IT (2019)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.
- 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.
- 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.
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