Come from：Shandong Caman Biotech Co., Ltd. Class：News Date：2019/12/3 浏览统计：588
On July 26, 2012, Amarin announced that the US Food and Drug Administration (FDA) has approved Vascepa (icosapent ethyl) capsules as an adjunct to diet therapy for adults with severe hypertriglyceridemia (TG levels ≥500 mg / dl). Drug for reducing triglyceride (TG) levels. Vascepa is an ultra-pure omega-3 fatty acid product.
The company evaluated the effectiveness and safety of Vascepa in a randomized, placebo-controlled, double-blind, parallel-group study.The subjects were adults with very fast TG levels (500-2000 mg / dl). patient. At baseline, 25% of patients received Vasce pa in combination with statins, 28% had diabetes, and 39% had TG levels> 750 mg / dl. Patients in the 4 g dose Vascepa treatment group had a median triglyceride level reduction of 33% after 12 weeks of treatment, which was statistically significant compared to the placebo control group (P <0.001), and their LDL cholesterol levels were relatively
There was no elevation in the placebo control group.Arthralgia was the most commonly reported adverse reaction in patients in the Vascepa treatment group.
Vascepa's effect on the risk of pancreatitis in patients with severe hypertriglyceridemia and its effect on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia have not been determined.
Vascepa has a daily dose of 4 g and is administered orally. Before and during treatment with Vascepa, patients should properly control their nutritional intake and physical activity.
Amarin expects Vascepa to be available in the first quarter of 2013.