“We are committed to serving patients with cardiovascular (CV) disease and the data presented at this year’s AHA annual meeting provide further evidence of the CV benefits of VASCEPA/ VAZKEPA in specified high-risk patients, potentially including those with peripheral artery disease,” said
Key data presented at AHA 2021:
Rapid Fire Oral Session Presentation
- “Benefits of Icosapent Ethyl in Patients with Prior Peripheral Artery Disease: REDUCE-IT PAD,”– presented on behalf of all authors by
Deepak L. Bhatt , M.D., M.P.H., Brigham and Women’s Hospital
Highlights: 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.”
For more information on this presentation, see Amarin’s previously issued press release, available here.
e-Poster Presentation
- Eicosapentaenoic Acid (
EPA ) Restores Pulmonary Endothelial Nitric Oxide Bioavailability Following Exposure to Urban Air Pollution Small Particles”– presented on behalf of all authors byR. Preston Mason , Ph.D., Brigham and Women’s Hospital
Highlights: This study examined the effects of
The study authors concluded that, “EPA significantly improved pulmonary endothelial cell function under conditions of inflammation caused by air pollution particles, including reductions in nitroxidative stress and the soluble adhesion molecule ICAM-1. These effects of
Late-Breaking Science Presentation
- “Icosapent Ethyl Versus Placebo In Outpatients With COVID-19: The Main Results Of PREPARE-IT 2” – presented on behalf of all authors and the PREPARE-IT 2 Trial Investigators by
Rafael Diaz , M.D., Estudios Cardiologicos Latinoamerica (ECLA),Rosario, Argentina
Highlights: These data represent the first presentation of the topline results from the PREPARE-IT 2 study, which was an investigator-initiated trial (IIT) to evaluate the efficacy of icosapent ethyl (IPE) to reduce hospitalizations or death in approximately 2000 patients in
While the results of the PREPARE-IT 2 study in
PREPARE-IT 1 and 2 are part of a series of IITs evaluating VASCEPA/VAZKEPA’s potential benefit in preventing and/or treating COVID-19. Amarin continues to support MITIGATE, another IIT study of IPE’s potential efficacy in the prevention of COVID-19.
The results of this study have no relationship to or bearing on any approved indications for VASCEPA/VAZKEPA.
All analyses highlighted above were supported or funded by Amarin.
Additional REDUCE-IT and icosapent ethyl-related topics presented at AHA Scientific Sessions 2021 can be found here.
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
About Cardiovascular Risk
Cardiovascular disease is the number one cause of death in the world. In
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%.iii 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. iv,v,vi
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
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the
Indications and Limitation of Use (in
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
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
- 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 vs Placebo | |||
N = 4089 n (%) | Incidence Rate (per 100 patient years) | N = 4090 n (%) | Incidence Rate (per 100 patient years) | ||
Primary composite endpoint | |||||
Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE) | 705 (17.2) | 4.3 | 901 (22.0) | 5.7 | 0.75 (0.68, 0.83) |
Key secondary composite endpoint | |||||
Cardiovascular death, myocardial infarction, stroke (3-point MACE) | 459 (11.2) | 2.7 | 606 (14.8) | 3.7 | 0.74 (0.65, 0.83) |
Other secondary endpoints | |||||
Fatal or non-fatal myocardial infarction | 250 (6.1) | 1.5 | 355 (8.7) | 2.1 | 0.69 (0.58, 0.81) |
Emergent or urgent coronary revascularization | 216 (5.3) | 1.3 | 321 (7.8) | 1.9 | 0.65 (0.55, 0.78) |
Cardiovascular death [1] | 174 (4.3) | 1.0 | 213 (5.2) | 1.2 | 0.80 (0.66, 0.98) |
Hospitalization for unstable angina [2] | 108 (2.6) | 0.6 | 157 (3.8) | 0.9 | 0.68 (0.53, 0.87) |
Fatal or non-fatal stroke | 98 (2.4) | 0.6 | 134 (3.3) | 0.8 | 0.72 (0.55, 0.93) |
[1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality. [2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. |
FULL
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, including beliefs about the world-wide market potential for VASCEPA (marketed as VAZKEPA in
Availability of Other Information About Amarin
Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and FAQs,
Amarin Contact Information
Investor Inquiries:
Investor Relations
In
IR@amarincorp.com (investor inquiries)
Solebury Trout
In
amarinir@troutgroup.com
Media Inquiries:
Communications
In
PR@amarincorp.com (media inquiries)
i Mason RP et al. Biomed Pharmacother. 2018;103:1231- 1237
ii
iii Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
iv Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
v Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk.
vi Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
vii Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
viii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.
ix Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.
Source:
2021 GlobeNewswire, Inc., source