Amarin Corporation plc (NASDAQ:AMRN) today announced the
publication of new REDUCE-IT data analysis that helps support the
clinical benefits of icosapent ethyl (IPE) for patients who have
received a percutaneous coronary intervention (PCI) and are at high
risk for experiencing a stroke, heart attack, or fatal
cardiovascular (CV) event.(1)
Percutaneous coronary interventions (also known
as coronary angioplasty, which can include stent insertion) are
medical procedures used to open coronary arteries, the main blood
vessels supplying the heart, that are narrowed or blocked by a
build-up of atherosclerotic plaque.(2) The heart needs a constant
supply of oxygenated blood to function effectively; if the coronary
arteries become narrowed and restricted, this can lead to serious
heart health complications such as angina or a heart attack.(3)
The REDUCE-IT Prior PCI study was a post hoc
sub-analysis published in the Journal of the American Heart
Association (JAHA). This publication furthers the clinical evidence
base for icosapent ethyl treatment in patients with prior PCI at
risk of a recurrent CV event.
There were 3,408 patients who had undergone a
prior PCI (41.7% of the initial REDUCE-IT study population). The
median time after PCI for these patients was 2.9 years. Baseline
characteristics were similar among patients randomised to icosapent
ethyl versus placebo. Of those patients with prior PCI included in
the sub-analysis receiving standard of care treatment only, 37.6%
experienced a major CV event (cardiovascular death, myocardial
infarction, stroke, coronary revascularization, or unstable angina
requiring hospitalization), compared with 25.6% of patients
receiving icosapent ethyl.(1)
In patients with a history of PCI, icosapent
ethyl treatment versus placebo reduced the first primary composite
endpoint of CV death, non-fatal myocardial infarction (MI) (heart
attack), non-fatal stroke, coronary revascularization, or unstable
angina, by 34% (absolute risk reduction of 8.5%, HR 0.66; 95% CI,
0.58-0.76; p<0.001); number needed to treat (NNT) =12) and the
total events (first and subsequent) by 39% (RR 0.61; 95% CI,
0.52-0.72; p<0.001).(1)
Icosapent ethyl also led to a 34% reduction in
the key secondary composite endpoint of CV death, non-fatal MI, or
non-fatal stroke versus placebo (absolute risk reduction 5.4%, HR
0.66; 95% CI, 0.56-0.79, p<0.001; NNT=19). The sub-analysis also
showed that icosapent ethyl treatment led to a 40% risk reduction
of repeat coronary revascularization versus placebo (absolute risk
reduction 7.7%, HR 0.60; 95% CI, 0.51-0.70; p<0.001) in patients
who have previously undergone PCI.(1)
Safety findings in the REDUCE-IT Prior PCI
subgroup were consistent with the full study cohort.(1)
The REDUCE-IT study enrolled 8,179 patients for
a median of 4.9 years, who were all receiving a stable dose of a
statin for at least 4 weeks. All patients had controlled
low-density lipoprotein cholesterol (LDL-C), elevated triglyceride
levels, and were either 45 years of age or older, with established
cardiovascular disease (CVD), or were 50 years of age or older,
with diabetes and other cardiovascular risk factors.(4)
It is important to note that the exploratory
nature limited this post hoc analysis. Other limitations noted by
the authors include that REDUCE-IT was not powered for sub-group
analyses and all P values should be considered
hypothesis-generating.
Commenting on the paper’s findings, 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 Prior
PCI analyses, said:
“This analysis from REDUCE-IT highlights the
benefits of icosapent ethyl in patients with elevated triglycerides
and a history of prior PCI, a commonly performed procedure. The
findings of benefit in at-risk patients with prior PCI are
consistent with previously published coronary revascularization
data demonstrating reductions in first and total coronary
revascularization events of 34% and 36%, respectively, in the
overall REDUCE-IT population.”(5)
Dr. Bhatt continued, “Patients on standard of
care treatment who nevertheless have elevated triglycerides are at
high-risk for recurrent CV events. Icosapent ethyl has the
potential to benefit a large proportion of these patients,
including those with a history of prior PCI.”(1)
There is evidence suggesting that patients who
have a prior PCI are at a heightened risk of subsequent CV events
compared with other patients with CV risk factors.(1) In recent
years, efforts to improve stent design, LDL-C, inflammation, and
platelet activity have reduced repeat events among patients who
undergo coronary stenting.(1)
Yet, many patients still experience recurrent
events, especially those with diabetes mellitus and elevated
triglycerides.(1) This suggests there may be a need for additional
treatments and interventions to reduce this remaining risk.
Karim Mikhail, Amarin's president and chief
executive officer, commented, “We continue to gain new insights
into the important role that IPE can play in helping patients with
CVD; especially for those most vulnerable to a serious or fatal
event. This latest analysis showed that IPE lowered the risk of
heart attack, stroke or cardiovascular death for patients with a
prior PCI -- offering additional evidence that our product can be a
vital contributor in reducing harm and deaths from cardiovascular
disease around the world.”
The REDUCE-IT PCI subgroup analysis was funded
by Amarin. Dr. Bhatt receives research funding from Amarin that
goes to Brigham and Women’s Hospital.
Release References1. Peterson BE, Bhatt DL,
Steg PG, et al. Treatment with Icosapent Ethyl to Reduce Ischemic
Events in Patients with Prior Percutaneous Coronary Intervention -
Insights from REDUCE-IT PCI. Originally published 9 Mar 2022
https://doi.org/10.1161/JAHA.121.022937, J Am Heart Assoc.
2022;0:e0229372.
https://www.nhlbi.nih.gov/health-topics/percutaneous-coronary-intervention
3. NHS UK. Coronary angioplasty and stent insertion
https://www.nhs.uk/conditions/coronary-angioplasty/ Accessed March
2022.4. Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med. 2019;380(1):11-22.5. Peterson BE, Bhatt DL, Steg PG, et al.
Reduction in Revascularization With Icosapent Ethyl: Insights From
REDUCE-IT Revascularization Analyses. Circulation.
2021;143(1):33-44.
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 yeari 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)
CapsulesVASCEPA (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
- 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:
FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
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 |
VASCEPAvs Placebo |
N = 4089n (%) |
Incidence Rate(per 100 patient
years) |
N = 4090n (%) |
Incidence Rate(per 100 patient
years) |
Hazard Ratio (95% CI) |
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. |
Forward-Looking StatementsThis
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
potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs
about icosapent ethyl (IPE)’s role concerning patients suffering
from cardiovascular disease (CVD) and impacts on the risk of heart
attack, stroke or cardiovascular death for patients with a prior
percutaneous coronary intervention (PCI) and general beliefs about
the safety and effectiveness of VASCEPA. These forward-looking
statements are not promises or guarantees and involve substantial
risks and uncertainties. A further list and description of these
risks, uncertainties and other risks associated with an investment
in Amarin can be found in Amarin's filings with the U.S. Securities
and Exchange Commission, including Amarin’s annual report on Form
10-K for the full year ended 2021. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date they
are made. Amarin undertakes no obligation to update or revise the
information contained in its forward-looking statements, whether as
a result of new information, future events or circumstances or
otherwise. Amarin’s forward-looking statements do not reflect the
potential impact of significant transactions the company may enter
into, such as mergers, acquisitions, dispositions, joint ventures
or any material agreements that Amarin may enter into, amend or
terminate. Availability of Other Information About 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, Securities and Exchange Commission filings,
press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Amarin Contact Information Investor Inquiries:
Investor Relations Amarin Corporation plc In U.S.: +1 (908)
719-1315 IR@amarincorp.com (investor inquiries)
Solebury Trout In U.S.: +1 (646) 378-2992
amarinir@troutgroup.com
Media Inquiries: Communications Amarin Corporation plc In U.S.:
+1 (908) 892-2028 PR@amarincorp.com (media inquiries)
About Section References
___________________________
i American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139-e596.ii 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.iii Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.iv 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. J Am Heart Assoc.
2018;7(15):e008740.v Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.vi 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.vii 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.viii 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.
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