VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Ischemic Events in Patients with Prior Percutaneous Coronary Intervention (PCI) in Post Hoc Subgroup Analyses of Landmark REDUCE-IT® Study Presented at Transcatheter Cardiovascular Therapeutics (TCT) Connect 2020
October 15, 2020 at 16:30 PM EDT
VASCEPA®, compared with placebo, significantly reduced primary composite first and total MACE (major adverse cardiovascular events) in post hoc exploratory analyses of patients with a history of PCI by 34% and 39%, respectively, and key secondary composite first hard MACE, comprised of heart attacks, stroke and cardiovascular death, by 34%
Administration of VASCEPA resulted in robust absolute risk reductions of 8.5% and 5.4% and numbers needed to treat (NNT) of 12 and 19, respectively, for both primary and key secondary (hard MACE) composite endpoints in post hoc exploratory subgroup analyses
Consistent and robust benefit seen in post hoc exploratory analyses of patients with a history of PCI across the hierarchy of endpoints prespecified for the full study cohort
DUBLIN, Ireland and BRIDGEWATER, N.J., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of REDUCE-IT® PCI at Transcatheter Cardiovascular Therapeutics (TCT) Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation, being held virtually from October 14 – October 18, 2020 adding to the growing body of knowledge on the clinical impact of VASCEPA® (icosapent ethyl). These new analyses supported by Amarin were presented during the TCT Connect 2020 Best of Abstracts session by Benjamin E. Peterson, M.D., Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School.
“The opportunity to further explore REDUCE-IT data and effects in those patients with prior PCI provides additional understanding of the potential benefit of icosapent ethyl in the clinical 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 and senior author of the REDUCE-IT PCI analyses. “The findings of benefit in at-risk patients with prior PCI are consistent with previously presented data on overall reductions in first and total coronary revascularization events of 34% and 36%, respectively. Moreover, the statistically significant substantial benefit in reduced coronary revascularization procedures seen as early as 11 months provides clinicians with a potential additional intervention in a patient population for whom time is of the essence.”
The REDUCE-IT PCI analysis looked at 3,408 (41.7%) of patients enrolled in REDUCE-IT who had undergone a prior PCI. These patients were randomized a median of 2.9 years after PCI. Baseline characteristics were similar among patients randomized to VASCEPA versus placebo. Post hoc exploratory analyses of the subgroup of 3,408 patients with a prior PCI showed that, for the primary composite endpoint of 5-point MACE, time to first event was significantly reduced with VASCEPA versus placebo by 34% (p<0.0001) and total (first and subsequent) events were also reduced by 39% (p<0.0001). For the key secondary composite endpoint of 3-point MACE, time to first event was reduced by 34% (p<0.0001) in the subgroup of patients with a prior PCI.
Coronary revascularization procedures, such as stenting, 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 480,000 inpatient PCI procedures were performed in the United States with a mean inpatient hospital charge for PCI of $84,813.1
“Revascularization procedures overall significantly impact the healthcare system, with PCI 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 TCT Connect 2020 reflect new findings demonstrating the substantial impact of VASCEPA on at-risk patients in REDUCE-IT with prior PCI procedures and how the therapy can help avoid subsequent events that could have dire consequences.”
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.
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