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What does the FDA approval for Vascepa cover? Vascepa, also known as icosapent ethyl, is a prescription medication that contains a specific type of omega-3 fatty acid. In 2019, the FDA approved Vascepa for reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease who are on background therapy, including statins and other cholesterol-lowering medications [1]. What cholesterol levels is Vascepa typically prescribed for? Vascepa is not a first-line treatment for high cholesterol. It is generally prescribed for patients with a history of cardiovascular disease who have triglyceride levels greater than 150 mg/dL, despite being on established statin therapy [1]. Vascepa has been shown to reduce triglyceride levels by approximately 20-30% and also has a moderate effect on lowering low-density lipoprotein (LDL) cholesterol (often referred to as "bad" cholesterol) [2]. Why is Vascepa specifically used for certain patients? The FDA approval for Vascepa is based on the REDUCE-IT trial, which demonstrated that patients with established cardiovascular disease who took Vascepa in addition to statin therapy had a 25% reduction in major adverse cardiovascular events compared to those who took a placebo. The trial specifically targeted patients with a history of cardiovascular disease and triglyceride levels above 150 mg/dL [3]. What happens if my triglyceride levels are below the target range? If you have a history of cardiovascular disease and your triglyceride levels are below 150 mg/dL, it is still worth discussing your options with your healthcare provider. They may consider alternatives or additional treatments as necessary. Sources: [1] https://www.drugpatentwatch.com/drug/vascepa (DrugPatentWatch.com) [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6544445/ (National Center for Biotechnology Information) [3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6235149/ (National Center for Biotechnology Information)
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