Date: 2014-06-11
Type of information: Publication of results in a medical journal
phase: retrospective analysis
Announcement: publication of results in Postgraduate Medicine
Company: Amarin (USA - NJ)
Product: Vascepa ® (icosapent ethyl) capsules
Action
mechanism: Vascepa® (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
Disease: Vascepa® (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
Therapeutic area: Metabolic diseases - Cardiovascular diseases
Country:
Trial details:
Latest
news: * On June 11, 2014, Amarin, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced the publication of a retrospective analysis of patient cases that examined the effect on lipid parameters in hyperlipidemic patients who were switched from Lovaza® (omega-3-acid ethyl esters) capsules, a mixture of omega fatty acids, to Vascepa® (icosapent ethyl) capsules, to potentially achieve better outcomes in triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C) levels.1 During the studied period, most of the 14 patients switched to Vascepa® experienced reductions in levels of triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C). The publication is titled, \"A Retrospective Case Series of the Lipid Effects of Switching from Omega-3 Fatty Acid Ethyl Esters to Icosapent Ethyl in Hyperlipidemic Patients,\" by Richard S. Castaldo. Dr. Castaldo conducted a retrospective chart review at 4 medical practice locations in Western New York of 14 treated patients who were initially diagnosed with high TG levels, or hyperlipidemia, and whose lipid parameters were measured two or more months after being switched to 4 g/day EPA-only Vascepa® from 4 g/day Lovaza®. The patients ranged from 45 to 79 years of age and were on their same prescription lipid-lowering background medication at the same dose throughout the studied period, with 10 patients on a statin, and 4 patients on a cholesterol absorption inhibitor. After being switched from Lovaza® to Vascepa®, 12 patients experienced a decrease in TG and LDL-C levels and 13 patients experienced a decrease in TC and non-HDL-C levels. Changes in high-density lipoprotein cholesterol (HDL-C) levels were also assessed, but the results were mixed, with no change in 1 patient, decreases in 9 patients, and increases in 4 patients. Dr. Castaldo\'s chart review also found Vascepa® to be well tolerated with a safety profile consistent with that referenced in the U.S. Food and Drug Administration (FDA) approved label for Vascepa®.
