VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Cardiovascular Events in Patients with Compromised Renal Function at Baseline in Prespecified and Post Hoc Subgroup Analyses of Landmark REDUCE-IT® Study Presented at American Society of Nephrology (ASN) Kidney Week 2020
October 26, 2020 at 07:00 AM EDT
Patients with decreased renal function prior to treatment with VASCEPA or placebo had higher rates of cardiovascular events than the overall population studied in REDUCE-IT
REDUCE-IT patients with decreased renal function prior to treatment showed similarly favorable relative risk reductions and numerically greater absolute risk reductions in cardiovascular events in comparison with the overall patient population
Consistent and robust benefit in cardiovascular outcomes seen in both prespecified and post hoc exploratory analyses across a broad range of baseline eGFR (estimated Glomerular Filtration Rate) categories
DUBLIN, Ireland and BRIDGEWATER, N.J., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the first presentation of REDUCE-IT® RENAL results at American Society of Nephrology (ASN) Kidney Week 2020, held virtually from October 22 – October 25. REDUCE-IT RENAL consisted of important prespecified and post hoc subgroup analyses of patients from the landmark REDUCE-IT cardiovascular outcomes study who had compromised renal function. The results of these analyses add to the growing body of knowledge on the clinical impact of VASCEPA® (icosapent ethyl) in at-risk patient populations. These new analyses, supported by Amarin, were presented by Arjun Majithia, M.D., Lahey Clinic.
“In the REDUCE-IT RENAL analyses we not only studied outcomes following icosapent ethyl administration, which were greatly improved, but equally importantly, we also examined the event rates in at-risk patients with compromised renal function, which clearly demonstrate that those patients urgently need additional solutions for cardiovascular risk reduction,” commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, principal investigator of REDUCE-IT and senior author of the REDUCE-IT RENAL analyses.
The REDUCE-IT RENAL analyses examined the full REDUCE-IT cardiovascular outcomes study patient population in prespecified and post hoc analyses across subgroups of eGFR categories. The primary endpoint (5-point major adverse cardiovascular events [MACE] consisting of non-fatal myocardial infarction [MI], stroke, cardiovascular death, unstable angina requiring hospitalization and coronary revascularization) and key secondary endpoint (3-point MACE consisting of non-fatal MI, stroke and cardiovascular death) events were consistently reduced when looking at data cut by prespecified baseline eGFR categories; eGFR <60 mL/min/1.73 m2 (n=1816), eGFR ≥60 to <90 mL/min/1.73 m² (n=4455), and eGFR ≥90 mL/min/1.73 m² (n=1902). Similar consistent cardiovascular risk reduction benefits were observed across post hoc analyses by finer cuts of eGFR categories. Primary and key secondary endpoint MACE rates increased with decreasing eGFR compared to the total patient population studied in REDUCE-IT, resulting in similarly favorable relative risk reductions and numerically greater absolute risk reductions with VASCEPA versus placebo in comparison with the overall patient population.
Adverse event rates were higher with decreasing eGFR, but total adverse events occurred at similar rates with VASCEPA versus placebo. A safety profile similar to the full REDUCE-IT study cohort was observed for VASCEPA compared with placebo across eGFR subgroups.
“We continue to see the consistency in benefit and safety of VASCEPA administration across various at-risk patient populations, including across varying degrees of renal function,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “It is notable that, despite observing with REDUCE-IT patients the known increase in cardiovascular events with decreased kidney function, all patients experienced similar relative cardiovascular risk reduction benefits, resulting in overall greater absolute risk reductions in patients with compromised kidney function.”
“It is important to provide cardiovascular risk reduction solutions for patients with chronic kidney disease as data continue to highlight cardiovascular disease as an unfortunate and damaging comorbidity,” added Craig Granowitz, M.D., Ph.D., Amarin’s senior vice president and chief medical officer.
REDUCE-IT was not specifically powered to examine individual cardiovascular endpoints or patient subgroups, and urine samples were not collected during the REDUCE-IT study.
In addition to presentation of REDUCE-IT RENAL at ASN Kidney Week 2020, as previously reported, a separate presentation was made of real-world data analysis of U.S. veterans showing that increased triglyceride levels in patients with compromised renal function is a potential predictor of increased risk of cardiovascular events.
Links to above cited data presented at ASN Kidney Week 2020
“Benefits of Icosapent Ethyl Across a Range of Baseline Renal Function in Patients with Established Cardiovascular Disease or Diabetes: Results of REDUCE-IT RENAL” – presented on behalf of all authors by Arjun Majithia, M.D. – available from October 23
“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
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%.2 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.3,4,5
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.6 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.7 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.8 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
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 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139–e596.