Does icosapent ethyl (IPE) reduce the risk of cardiovascular outcomes in adult patients with hypercholesterolemia?
Näytönastekatsaukset
24.9.2026
Level of evidence: C
Icosapent ethyl may reduce the risk of cardiovascular events in patients with hypertriglyceridemia.
The certainty of evidence is downgraded due to inconsistency and indirectness. The large part of evidence is based on a RCT conducted in older women in Japan. In Western settings, icosapent ethyl may reduce the risk of CV events with 5 % (17 vs. 22% in placebo group) in 4.9 years of follow-up.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias «Additional comments for included studies»2 |
|---|---|---|---|---|---|
| RCT=randomized controlled trial | |||||
| «Bhatt DL, Steg PG, Miller M, ym. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380(1):11-22 »1 | RCT | Multicenter (473 sites in 11 countries) study with 8179 patients between November 28, 2011 and August 4, 2016. (REDUCE-IT) | 2 g of icosapent ethyl twice daily (total daily dose, 4 g) or placebo | Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. | low |
| «Yokoyama M, Origasa H, Matsuzaki M, ym. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet »2 | RCT | 18645 patients with a total cholesterol > 6·5 mmol/L were recruited in Japan between 1996 and 1999. (JELIS) | 1800 mg of EPA daily with statin or statin only | any major coronary event (sudden cardiac death, fatal and non-fatal myocardial infarction, unstable angina pectoris, angioplasty, stenting, or coronary artery bypass grafting | low |
| Reference | Comments |
|---|---|
| «Bhatt DL, Steg PG, Miller M, ym. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380(1):11-22 »1 | Patients were 45 years of age or older. The median was 64 years; 28.8% were female, and 38.5% were from the United States. Patients aged ≥45 years with cardiovascular disease or ≥50 years with diabetes and ≥1 cardiovascular risk factor were included. Patients were further selected to be on statin treatment consistently for at least 4 weeks. Patients were included if they had triglycerides of 135 to 499 mg/dL and LDL-C of 41 to 100 mg/dL. The blinded investigators on each site collected and reported potential endpoints, and they were subsequently adjudicated by a blinded Clinical Endpoint Committee (CEC) according to a predetermined charter. The median follow-up time was 4.9 years (IQR: 3.5-5.3 years) |
| «Yokoyama M, Origasa H, Matsuzaki M, ym. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet »2 | The mean age of all patients was 61 years and 12 786 patients (69%) were women. Mean concentrations of total cholesterol and triglyceride were 7.1 mmol/L and 1.7 mmol/L; and mean LDL and HDL cholesterol concentrations were 4.7 mmol/L and 1.5 mmol/L, respectively. The study participants were not blinded. |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Hazard ratio (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: low The quality of evidence is downgraded due to inconsistency and imprecision I=intervention; C=comparison; CI=confidence interval | |||||
| «Bhatt DL, Steg PG, Miller M, ym. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380(1):11-22 »1 | 1 (4089/4090) | median 4.9 yrs | 705 (17%) | 901 (22%) | 0.75 (0.68,0.83) |
| «Yokoyama M, Origasa H, Matsuzaki M, ym. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet »2 | 1 (9326/9319) | mean 4.6 years | 262 (2.8%) | 324 (3.5%) | 0.81 (0.69,0.95) |
References
- Bhatt DL, Steg PG, Miller M, ym. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380(1):11-22 «PMID: 30415628»PubMed
- Yokoyama M, Origasa H, Matsuzaki M, ym. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet 2007;369(9567):1090-8 «PMID: 17398308»PubMed