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    Home > Medical News > Medical Research Articles > EMA accepts Amarin's new indications from cosapent ethyl

    EMA accepts Amarin's new indications from cosapent ethyl

    • Last Update: 2020-06-07
    • Source: Internet
    • Author: User
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    recently, Amarin(http://announced that the EuropeanMedicines(http://Authority (EMA) has accepted its submission of fish oil-deriveddrug(http://icosapent ethyl (20 carbon pentaelate, Vascepa) for those taking statins to control cholesterol levels but high triglycerides (more than 135mg/dL)The EMA is expected to complete the review by the end of 2020In the United States and the European Union, icosapent ethyl's new indications applications are based on the results of the landmark cardiovascular outcome study REDUCE-ITThe study, a global study, included a group of 8,179 high-risk patients who had been treated with statins whose LDL-C was well controlled but whose risk of CV events remained highThe study assessed the efficacy and safety of icosapent ethyl (4g per day) relative to placebo, with a median follow-up time of 4.9 yearsThe results showed that the study reached its main endpoint, with icosapent ethyl reducing the relative risk of the first major adverse cardiovascular event (MACE) by 25% compared to placebo in the intended treatment group, and the data were highly statistically significant (HR:0.75, 95% CI: 0.68-0.83, p.001)MACE consists of cardiovascular death, non-fatal myocardial infarction (MI or heart attack), non-lethal stroke, coronary revascularization (such as stent and bypass surgery), and unstable angina requiring hospitalizationIn addition, in published exploratoryanalysis (http:// , icosapent ethyl reduced the relative risk of total (first and subsequent) cardiovascular events by 30 percent compared to placebo, which was statistically significant   In the United States and the European Union, icosapent ethyl's new indications applications are based on the results of the landmark cardiovascular outcome study REDUCE-IT   The study, a global study, included a group of 8,179 high-risk patients who had been treated with statins whose LDL-C was well controlled but whose risk of CV events remained high The study assessed the efficacy and safety of icosapent ethyl (4g per day) relative to placebo, with a median follow-up time of 4.9 years   The results showed that the study reached its main endpoint, with icosapent ethyl reducing the relative risk of the first major adverse cardiovascular event (MACE) by 25% compared to placebo in the intended treatment group, and the data were highly statistically significant (HR:0.75, 95% CI: 0.68-0.83, p.001)   In terms of safety
    MACE consists of cardiovascular death, non-fatal myocardial infarction (MI or heart attack), non-lethal stroke, coronary revascularization (such as stent and bypass surgery), and unstable angina requiring hospitalization   In addition, in published exploratory analysis, icosapent ethyl reduced the relative risk of total (first and subsequent) cardiovascular events by 30 percent compared to placebo, and the data were statistically significant
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