U.S. Veterans with Decreased Renal Function Shown to Be at Higher Risk for Adverse Cardiovascular Events if They Have Moderately Elevated Triglyceride (TG) Levels Despite Well-Controlled Low-Density Lipoprotein (LDL)-Cholesterol
October 23, 2020 at 07:00 AM EDT
DUBLIN, Ireland and BRIDGEWATER, N.J., Oct. 23, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of real-world evidence data at American Society of Nephrology (ASN) Kidney Week 2020, held virtually from October 22 – October 25, 2020, adding to the growing body of knowledge on the association of elevated triglyceride (TG) levels with increased cardiovascular (CV) risk independent of cholesterol management. These new analyses, conducted by the U.S. Department of Veterans Affairs and supported by Amarin, were presented in a poster presentation by Sarah Leatherman, Ph.D., U.S. Department of Veterans Affairs.
This retrospective analysis used real-world data from the U.S. Veterans Affairs Corporate Data Warehouse between 2010 and 2015. The analysis consisted of patients (N=152,266 veterans) not treated for triglyceride management who had baseline statin-controlled low-density lipoprotein (LDL)-cholesterol levels (40-100 mg/dL) and decreased renal function (eGFR <60 ml/min). Of these patients, 43,670 (29%) had elevated TG levels (150 to 499 mg/dL). This cohort of patients was compared to patients with similarly statin-controlled LDL-cholesterol and decreased renal function but with normal baseline TG levels (<150 mg/dL). Veterans within the cohort with elevated TG levels experienced higher rates of both composite and individual major adverse events cardiovascular events (non-fatal myocardial infarctions, stroke, unstable angina and coronary revascularization) than the control cohort. The overall crude and adjusted cardiovascular event rate ratios were 1.28 (95% CI 1.23,1.33) and 1.12 (95% CI 1.07,1.16), respectively. While the analysis supports the hypothesis that elevated TG levels are an independent identifier of cardiovascular risk, the analysis did not assess the extent to which lowering TG levels results in lower CV risk.
“The U.S. Department of Veterans Affairs analysis presented at ASN Kidney Week 2020 shows that veterans with decreased renal function and elevated triglycerides are at an increased risk of having a major adverse cardiovascular event, supporting the need to look at elevated triglycerides as an independent marker of cardiovascular risk, even more so in already high-risk patients like those analyzed in the study,” said Craig Granowitz, M.D., Ph.D., Amarin’s senior vice president and chief medical officer.
These results add further support to recent epidemiological and genetic linkage studies which have shown that elevated baseline TG levels could potentially be a factor in an increased incidence of cardiovascular events.1,2,3
Notable presentations at ASN Kidney Week 2020
“Increased Residual Cardiovascular Risk in US Veterans with Moderately Elevated Baseline Triglycerides, Well-Controlled LDL Cholesterol Levels on Statins, and Decreased Renal Function” – presented on behalf of all authors by Sarah Leatherman, Ph.D. – available from October 22
“Benefits of Icosapent Ethyl Across a Range of Baseline Renal Function in Patients with Established Cardiovascular Disease or Diabetes: Results of REDUCE-IT RENAL” – to be presented on behalf of all authors by Arjun Majithia, M.D. – October 23, 5:00 – 7:00 pm EDT
Additional information on ASN Kidney Week 2020 can be found here.
About Cardiovascular Risk
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.5 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.6,7,8
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.9 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.10 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.11 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
Indications and Limitation of Use
° established cardiovascular disease or
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with
Availability of Other Information About Amarin
Amarin Contact Information
Lee M. Stern
1 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.