VASCEPA/VAZKEPA found in prespecified and post hoc analyses to reduce total ischemic events by 32% in patients with prior PAD
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 15, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that data adding to the growing body of knowledge on VASCEPA®/VAZKEPA (icosapent ethyl) in patients with prior peripheral artery disease (PAD) at risk for major adverse cardiovascular events were delivered in a Rapid Fire Oral Session Presentation at the American Heart Association (AHA) Scientific Sessions 2021, which took place virtually from November 13-15, 2021.
The presentation, titled, “Benefits of Icosapent Ethyl in Patients with Prior Peripheral Artery Disease: REDUCE-IT PAD,” was presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, Professor of Medicine at Harvard Medical School, and principal investigator of REDUCE-IT® and was available On-Demand beginning on November 13, 2021 at 8:00 am ET through the completion of AHA Scientific Sessions 2021.
The Rapid Fire Oral Session presentation included both prespecified and post hoc analyses of patients who had PAD prior to randomization in the REDUCE-IT study to determine if treatment with VASCEPA (icosapent ethyl) reduced further ischemic events in those subjects.
“The REDUCE-IT prior PAD analyses provide valuable data supporting a potentially effective new approach to prevent ischemic events using prescription icosapent ethyl in patients with prior PAD,” commented Dr. Bhatt. “The potential benefits for patients with prior PAD are particularly important given these patients are at significantly higher risk of cardiovascular morbidity and mortality. These results strongly support the case for pure eicosapentaenoic acid (EPA) in the form of prescription icosapent ethyl as a key intervention beyond statins for meaningful risk reduction by physicians caring for their high-risk PAD patients.”
The investigators concluded that, “Icosapent ethyl 4 g/day significantly reduced total (first and subsequent) primary endpoints by 32%, and trended toward a 22% reduction in first events, in patients with PAD. Icosapent ethyl provides substantial cardiovascular risk reduction in the high-risk REDUCE-IT population, with consistent benefits in patients with a history of PAD. Safety was generally consistent with the overall study. Overall tolerability and adverse events were generally similar between icosapent ethyl and placebo in patients with prior PAD. More atrial fibrillation/flutter occurred with icosapent ethyl versus placebo in patients with prior PAD (5.2% versus 2.6%, respectively; P=0.07). No differences in bleeding were observed between icosapent ethyl and placebo in patients with prior PAD, likely due to the sample size.”
“Amarin is committed to serving patients at high risk of cardiovascular events and these new data add to our growing body of clinical evidence in support of its benefits to reduce that risk in patients with prior PAD,” stated Steven Ketchum, Ph.D., executive vice president and president, research & development and chief scientific officer, Amarin. “For these patients, the demonstrated cardiovascular risk reduction of VASCEPA/VASKEPA could be an important, and potentially life-saving, addition to their treatment regimen.”
Additional REDUCE-IT and icosapent ethyl-related topics to be presented at AHA Scientific Sessions 2021 can be found here.
Dr. Bhatt receives research funding paid to Brigham and Women’s Hospital from Amarin for his role as the Chair of REDUCE-IT.
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our foundation in scientific research to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk.
About Cardiovascular Risk
Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.i And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds.
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%.ii 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. iii,iv,v
About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
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.vi The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.vii The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.viii 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
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United States)
VASCEPA is indicated:
As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
Common adverse reactions in the hypertriglyceridemia trials (incidence 1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
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
Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT
VASCEPA | Placebo | VASCEPA | |||
N = | Incidence | N = | Incidence | Hazard Ratio | |
Primary composite endpoint | |||||
Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE) | 705 | 4.3 | 901 | 5.7 | 0.75 |
Key secondary composite endpoint | |||||
Cardiovascular death, myocardial infarction, stroke (3-point MACE) | 459 | 2.7 | 606 | 3.7 | 0.74 |
Other secondary endpoints | |||||
Fatal or non-fatal myocardial infarction | 250 | 1.5 | 355 | 2.1 | 0.69 |
Emergent or urgent coronary revascularization | 216 | 1.3 | 321 | 1.9 | 0.65 |
Cardiovascular death [1] | 174 | 1.0 | 213 | 1.2 | 0.80 |
Hospitalization for unstable angina [2] | 108 | 0.6 | 157 | 0.9 | 0.68 |
Fatal or non-fatal stroke | 98 | 0.6 | 134 | 0.8 | 0.72 |
[1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality. | |||||
FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995,…
Amarin Reports Subgroup Data from REDUCE-IT® Highlighting Benefits of VASCEPA®/VAZKEPA