Major milestones in cardiovascular prevention! "Fish oil" vascepa was approved as the first drug to assist statins to reduce cardiovascular risk in high-risk patients!

Author: tomato HLS therapeutics is a pharmaceutical company specializing in the central nervous system and cardiovascular market Recently, the company announced that the Health Canada has approved the fish oil derivative vascepa (icosapentetyl, eicosapentaenoic acid ethyl ester) for the treatment of statins, the presence of high triglycerides, the high risk of cardiovascular events due to the presence of cardiovascular disease or diabetes, and the presence of at least one other cardiovascular risk factor, so as to reduce cardiovascular risk Risk of events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, unstable angina requiring hospitalization) Vascepa was developed by amarin, and HLS authorized the exclusive rights of the drug in Canada in 2017 The company plans to market the product in mid February 2020 In the United States, vascepa obtained FDA approval for the new indications and label extension on December 13, 2019 After more than ten years of development and testing, vascepa is now the first and only drug approved by FDA - as an adjuvant therapy of statins with the maximum tolerable dose, it is used in adult patients with elevated triglyceride (TG) (≥ 150mg / dl), cardiovascular disease or diabetes mellitus, and two or more cardiovascular risk factors, to reduce myocardial infarction, stroke, crown Risk of UA revascularization, unstable angina requiring hospitalization Cardiovascular disease is the leading cause of death worldwide Vascepal is the first drug approved to effectively reduce the risk of residual cardiovascular events in patients with dyslipidemia whose LDL-C level is controlled but TG level is still high after treatment with statins The launch of the drug will provide medical staff with a new treatment option to enhance cardiovascular protection for many individuals at risk of heart disease This approval is based on the results of the landmark cardiovascular outcome study, reduce-it Deepak L Bhatt, chief investigator of the study, Professor of medicine at Harvard Medical School, and executive director of cardiovascular interventional therapy program at bregen and women's Hospital, previously said: "vascepa was approved as a supplement to statins to reduce the risk of cardiovascular events, which is an important milestone in cardiovascular prevention Since the advent of statins nearly 30 years ago, there has not been such a significant change in the field of cardiovascular disease prevention Many patients will benefit from this historic nursing advancement " Reduce-it is a global study involving 8179 high-risk patients who have been treated with statins These patients have good LDL-C control, but the risk of CV events is still high The efficacy and safety of vascepa (4G / day) relative to placebo were evaluated in the study, with a median follow-up of 4.9 years The results showed that the study reached the primary end point In the intention to treat group, vascepa reduced the relative risk of major adverse cardiovascular events (MACE) for the first time by 25% compared with placebo, and the data was highly statistically significant (HR = 0.75, 95% CI: 0.68-0.83, P < 0.001) Mace consists of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), nonfatal stroke, coronary revascularization (such as stent and bypass surgery), and unstable angina requiring hospitalization In addition, in the published exploratory analysis, vascepa reduced the relative risk of total (first and subsequent) cardiovascular events by 30% compared with placebo, and the data were statistically significant In this study, the most common adverse events (incidence > 5% and higher than placebo group) in the vascepa treatment group were peripheral edema (6.5% vs 5.0%), constipation (5.3% vs 3.6%), and atrial fibrillation (5.3% vs 3.9%) Cardiovascular disease is still the number one killer in the world Although statins can reduce the risk of cardiovascular adverse events, the level of triglyceride (TG), an important indicator of cardiovascular disease, is still high in many patients when the level of low-density lipoprotein cholesterol (LDL-C) falls to the standard, which poses a serious challenge to health Vascepa is a high purity EPA (eicosapentaenoic acid) single molecule prescription product extracted from deep sea fish by strict, complex and FDA supervised production process The production process of the product can effectively eliminate impurities and separate and protect the single molecule active ingredients Vascepa has also won many international patents due to its unique clinical characteristics Vascepa reduced triglyceride (TG) levels without increasing LDL-C levels in related patient groups In the United States, vascepa was approved by FDA in 2012 to assist in diet control and reduce triglyceride (TG) levels in adults with severe (≥ 500mg / dl) hypertriglyceridemia Since its launch in 2013, there have been more than 8 million prescriptions for this important niche indication Currently, vascepa is being reviewed by the European Drug Administration (EMA) to reduce the risk of CV events in high-risk patients who take statins to control cholesterol levels but have high triglycerides (135mg / dL or more) and other cardiovascular (CV) risk factors EMA expects to complete the review by the end of 2020 HLS therapeutics announcements Health Canada approval for vascepa ® to reduce the risk of cardiovascular events