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 Ri...»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...»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 Ri...»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...»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 Ri...»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...»2 | 1 (9326/9319) | mean 4.6 years | 262 (2.8%) | 324 (3.5%) | 0.81 (0.69,0.95) |