Tuesday, September 17, 2019 2:42:33 AM
Shreya Chandra, MD
Internal Medicine/Pediatrics
La Mesa Medical Center
REDUCE-IT is the first trial to evaluate the effect of icosapent ethyl on clinical outcomes. In this trial, over 8000 patients with elevated triglyceride levels (fasting 135 to 499 mg/dL [1.52 to 5.63 mmol/L]), on statins, and either established cardiovascular disease or diabetes plus other cardiovascular risk factors were randomly assigned to supplementation with icosapent ethyl 4 g/day, or mineral oil. Icosapent ethyl reduced the risk of the primary combined cardiovascular disease endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina (17.2 versus 22.0 percent, HR 0.75, 95% CI 0.68-0.83) after median follow-up of 4.9 years [109]. The rates of each component of the primary composite endpoint were also significantly reduced. From baseline to one year, the median triglyceride level decreased 18 percent in the treatment group and increased 2.2 percent in the control group. LDL-C levels increased in both groups
(treatment group 3.1 percent, control group 10.2 percent). At two years, C-reactive protein levels decreased by 13.9 percent in the treatment group and increased by 32.2 percent in the control group.
Limitations of the REDUCE-IT trial include concerns that mineral oil may have caused the increases in atherogenic lipoproteins and C-reactive proteins in the control group and thus did not function as a true placebo. These adverse effects of mineral oil may have raised the risk of cardiovascular events in the control group and may partially account for the favorable risk reduction observed in the treatment group. If so, the true cardiovascular effect of icosapent ethyl may be less than observed in the trial. Another concern is that rates of new-onset atrial fibrillation were significantly higher in the treatment group (5.3 versus 3.9 percent).
The authors and editors of this topic are divided regarding recommendations for use of icosapent ethyl, based on the limitations of the trial. If a fish oil capsule is to be considered for reduction of cardiovascular risk in patients with triglyceride levels 149 to 500 mg/dL, we support the use of iscospent ethyl based on the results of REDUCE-IT, if it is used in combination with a statin as in the study population. However, further evaluation of the efficacy and safety of these findings from ongoing trials is recommended before a firm recommendation can be made.
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