Is FDA approved by Vascepa

And it still protects: Highly dosed EPA for secondary prevention

Vascepa has received FDA approval as a dietary supplement to reduce elevated triglyceride levels in patients with severe hypertriglyceridaemia (≥ 500 mg / dl). One capsule contains 1 g icosapent ethyl. This is a high quality ethyl eicosapentaenoate. According to the manufacturer, it is not fish oil, but an active ingredient isolated from fish. There is no belching after fish as with conventional preparations or a fishy taste. There is currently no approved drug in Germany. In this country, combinations of EPA and DHA are on the market. The recommended dosage for Vascepa is two capsules twice a day, alternatively you can switch to four capsules of 0.5 mg twice a day.

About the study: Reduce-it is a multicenter, randomized, double-blind, placebo-controlled study with 8179 participants with elevated triglyceride values ​​(135 to 499 mg / dl) and low LDL values ​​(41 to 100 mg / dl). The subjects were being treated with a statin and had already had a cardiovascular event or had diabetes. Another cardiovascular risk factor had to be present. Around 71 percent of the test persons took part in Reduce-it as part of secondary prevention. Study participants were treated with either Vascepa 2 g twice daily or placebo. A combination of cardiovascular death, non-fatal stroke or myocardial infarction, coronary revascularization, or unstable angina pectoris was established as the primary endpoint.

The patients were followed up for a median of 4.9 years. The primary endpoint was achieved by 17.2 percent of the participants on verum and 22 percent of the test subjects on placebo. A significant relative risk reduction of 25 percent was thus observed for high-dose icosapent ethyl.