VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Ischemic Events in Patients with Prior Coronary Artery Bypass Grafting (CABG) Procedures in Post Hoc Subgroup Analyses of Landmark REDUCE-IT® Study Presented at American Heart Association’s Virtual Scientific Sessions 2020
November 13, 2020 at 10:00 AM EST
VASCEPA®, compared with placebo, significantly reduced primary composite first and total major adverse cardiovascular events (MACE) in post hoc exploratory analyses of patients with a history of CABG by 24% and 36%, respectively, and key secondary composite first hard MACE, comprised of heart attacks, stroke and cardiovascular death, by 31%
Administration of VASCEPA resulted in robust absolute risk reductions of 6.2% and 6.0% and numbers needed to treat (NNT) of 16 and 17, respectively, for both primary and key secondary (hard MACE) composite endpoints in these subgroup analyses
Amarin to Webcast Discussion of Presented Data on November 18, 2020 at 4:30 p.m., Eastern Standard Time
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of REDUCE-IT® CABG at American Heart Association’s (AHA) Virtual Scientific Sessions 2020, being held virtually from November 13 – November 17, 2020, adding to the growing body of knowledge on the clinical impact of VASCEPA® (icosapent ethyl). These new analyses supported by Amarin were presented by Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto.
“The REDUCE-IT CABG analysis results are another piece of the puzzle when looking at the potential use of icosapent ethyl in the procedural setting,” 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. “The findings of benefit in at-risk patients with prior CABG are consistent with previously presented data on overall reductions in first and total coronary revascularization events, as well as in patients with prior percutaneous coronary interventions, and further strengthen the case for consideration of icosapent ethyl as an additional intervention for use by physicians to care for this patient population.”
The REDUCE-IT CABG analysis examined 1,837 (22.5%) of the patients enrolled in REDUCE-IT, representing all patients who had undergone a prior coronary artery bypass grafting (CABG) procedure, a common form of surgical intervention to help treat coronary heart disease. Baseline characteristics were similar among patients randomized to VASCEPA versus placebo. Post hoc exploratory analyses of this subgroup showed that, for the composite endpoint of 5-point MACE, which was the prespecified primary endpoint for the full REDUCE-IT study cohort, time to first event was significantly reduced with VASCEPA versus placebo by 24% (p=0.004) and total (first and subsequent) events were also reduced by 36% (p=0.0002). For the REDUCE-IT study’s key secondary composite endpoint of 3-point MACE, time to first event was reduced by 31% (p=0.001) in the subgroup of patients with a prior CABG.
Coronary revascularization procedures, such as CABG, are invasive, carry multiple risks, and can have significant direct and indirect costs. Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. These procedures, whether pre-scheduled or performed in an emergency, inevitably result in additional time spent in a healthcare setting. The latest statistical update from the American Heart Association (AHA) shows that, in 2014, an estimated 371,000 inpatient CABG procedures were performed in the United States with a mean inpatient hospital charge for CABG of $168,541.1
“Revascularization procedures overall significantly impact the healthcare system, with CABG procedures adding to the burden and driving substantial costs,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “The subgroup data presented at AHA Virtual Scientific Sessions 2020 suggests another way in which VASCEPA can possibly alleviate the significant burden that at-risk patients and the healthcare system face with CABG procedures and how VASCEPA therapy can potentially reduce the risk of dangerous subsequent events.”
REDUCE-IT was not specifically powered to examine individual cardiovascular endpoints or patient subgroups, therefore p-values presented for these revascularization analyses are nominal and exploratory with no adjustment for multiple comparisons. In addition, coronary revascularization as an endpoint can sometimes be considered subjective; however, these endpoints were adjudicated by an independent, blinded clinical endpoint committee. Results from the total coronary revascularization events analyses are consistent across the various recurrent event statistical models and are also consistent with the first coronary revascularization events results. Together, the REDUCE-IT first and total coronary revascularization events results support the robustness and consistency of the clinical benefit of VASCEPA therapy in reducing coronary revascularization.
These REDUCE-IT CABG results follow multiple scientific presentations of analysis results from other important patient subgroups in the REDUCE-IT study, including REDUCE-IT REVASC2 and REDUCE-IT PCI. References to these other subgroup analyses are available on Amarin’s website at www.amarincorp.com.
Additional information on AHA Virtual Scientific Sessions 2020 can be found here.
Audio Webcast Information
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%.3 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.4,5,6
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.7 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.8 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.9 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
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