Amarin Corporation plc (NASDAQ:AMRN) today announced that data from
the REDUCE-IT® study presented during the 80th Scientific Sessions
of the American Diabetes Association by Deepak L. Bhatt, M.D.,
M.P.H., Brigham and Women’s Hospital Heart & Vascular Center
and Harvard Medical School, showed that administration of 4 g/day
of VASCEPA® (icosapent ethyl) resulted in significant 23%
reductions in both first and total primary composite major adverse
cardiovascular events (5-point MACE) in people with diabetes.
Reductions of 30% and 29% were observed in both first and total
hard (3-point) MACE, the key secondary composite endpoint,
respectively. The late-breaking presentation, titled “Substantial
Cardiovascular Benefit from Icosapent Ethyl in Patients with
Diabetes: REDUCE-IT DIABETES” was heard on June 13, 2020 at 10:00
am CST.
The leading cause of morbidity and mortality in
type 2 diabetes mellitus continues to be cardiovascular disease,
especially in those patients who already have established
atherosclerotic cardiovascular disease (ASCVD).1 Above normal
blood levels of triglycerides (TG) are common in patients with
diabetes,2,3 and have been associated with increased ASCVD (30% and
23% higher risk for non-fatal myocardial infarction (MI) and
stroke, respectively) in this patient population, despite statin
therapy.4
Many of the world’s leading diabetes and
cardiovascular disease professional societies, including the
American Diabetes Association (ADA) and the American Heart
Association (AHA), are working to educate patients and clinicians
on the urgent need to identify and manage risk with appropriate
therapies. The AHA Scientific Statement on Clinical Management of
Stable Coronary Artery Disease in Patients with Type 2 Diabetes
Mellitus, published in April of this year, states that “icosapent
ethyl is the first non–LDL (low-density lipoprotein)-focused lipid
therapy to demonstrate cardiovascular benefit and should be
considered first-line therapy for patients with T2DM (type 2
diabetes mellitus) and CAD (coronary artery disease) whose
triglycerides remain elevated (>135 mg/dL) despite maximally
tolerated statin and lifestyle changes.”1
“People with diabetes are at markedly increased
risk of cardiovascular disease, and that intersection has become a
target for research and a focus for clinical care,” commented Dr.
Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional
Cardiovascular Programs at Brigham and Women’s Hospital Heart &
Vascular Center and Professor of Medicine at Harvard Medical
School, and senior author of the REDUCE-IT DIABETES analyses. “In
these analyses, we see the substantial impact that icosapent ethyl
could have on reducing cardiovascular risks and complications from
diabetes.”
The prespecified tertiary and post hoc
exploratory analyses from the REDUCE-IT study showed that, for the
primary composite endpoint of 5-point MACE, time to first event was
significantly reduced with VASCEPA versus placebo by 23%
(p<0.0001) and total (first and subsequent) events were also
reduced by 23% (p=0.0003) in the subgroup of people with diabetes.
For the key secondary composite endpoint of 3-point MACE, time to
first event was reduced by 30% (p<0.0001) and total events were
reduced by 29% (p<0.0001) in the subgroup of people with
diabetes. Observed reductions in MACE were supported by further
post hoc exploratory analyses of the data across cardiovascular
risk category and diabetes status at baseline.
“The REDUCE-IT DIABETES subgroup analyses
further our understanding of the potential for VASCEPA to benefit
people with diabetes,” said Steven Ketchum, Ph.D., senior vice
president and president, research & development and chief
scientific officer, Amarin. “The data in our analyses shows
consistent outcomes across the at-risk population and supports that
VASCEPA can help reduce the already significant burden of
cardiovascular disease in people with diabetes.”
These REDUCE-IT analyses suggest benefits with
VASCEPA that are incremental to those of statin and other therapies
with known cardiovascular benefit, including anti-diabetic
medications that were well-utilized across people with diabetes,
approximately half of whom were taking two or more anti-diabetic
therapies.
REDUCE-IT was not specifically powered to
examine patient subgroups, therefore p-values presented for these
diabetes analyses are nominal and exploratory with no adjustment
for multiple comparisons. In addition, while the cardiovascular
risk categories of established cardiovascular disease or diabetes
plus additional risks were stratification factors, the presence or
absence of diabetes in patients with established cardiovascular
disease was not. These REDUCE-IT DIABETES results include both
prespecified tertiary and post hoc exploratory analyses.
Nonetheless, results from these time to first and total events
analyses consistently suggest benefit across the various endpoints
and recurrent event statistical models. Together, the REDUCE-IT
DIABETES first and total events results support the robustness and
consistency of the clinical benefit of VASCEPA therapy beyond
current standards of medical management in reducing cardiovascular
events in patients with diabetes.
Slides from the presentation will be made
available on www.acc.org.
Financial Disclosure
Funding from Amarin was provided to Brigham and
Women’s Hospital for Dr. Deepak L. Bhatt’s work as the REDUCE-IT
study chair and global principal investigator.
About Amarin
Amarin Corporation plc is a rapidly growing,
innovative pharmaceutical company focused on developing and
commercializing therapeutics to cost-effectively improve
cardiovascular health. Amarin’s lead product, VASCEPA® (icosapent
ethyl), is available by prescription in the United States, Canada,
Lebanon and the United Arab Emirates. Amarin, together with its
commercial partners in select geographies, is pursuing additional
regulatory approvals for VASCEPA in China, the European Union and
the Middle East. For more information about Amarin, visit
www.amarincorp.com.
About Cardiovascular Risk
The number of deaths in the United States
attributed to cardiovascular disease continues to rise. There are
605,000 new and 200,000 recurrent heart attacks per year
(approximately 1 every 40 seconds), in the United States. Stroke
rates are 795,000 per year (approximately 1 every 40 seconds),
accounting for 1 of every 19 U.S. deaths. Cardiovascular disease
results in 859,000 deaths per year in the United States.5 In
aggregate, this is more than 2.4 million major adverse
cardiovascular events per year from cardiovascular disease or, on
average, one every 13 seconds in the United States alone.
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%.6 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.7,8,9
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.10 The primary results of REDUCE-IT were published in
The New England Journal of Medicine in November 2018.11 The total
events results of REDUCE-IT were published in the Journal of the
American College of Cardiology in March 2019.12 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 FDA comprised
solely of the active ingredient, icosapent ethyl (IPE), a unique
form of eicosapentaenoic acid. 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 eight million times. VASCEPA is covered by most major medical
insurance plans. The new, cardiovascular risk indication for
VASCEPA was approved by the FDA in December 2019.
Indications and Limitation of Use
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) |
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. |
FULL VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements regarding the potential impact of
VASCEPA in various clinical uses. These forward-looking statements
are not promises or guarantees and involve substantial risks and
uncertainties. Among the factors that could cause actual results to
differ materially from those described or projected herein include
the following: uncertainties associated generally with research and
development and clinical trials such as further clinical
evaluations failing to confirm earlier findings. 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
its most recent Quarterly Report on Form 10-Q. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. Amarin undertakes no obligation to update or revise the
information contained in this press release, 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
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor 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:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315investor.relations@amarincorp.com (investor inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028PR@amarincorp.com (media inquiries)
___________________________________
1 Arnold SV, Bhatt DL, Barsness GW, et al. Clinical Management
of Stable Coronary Artery Disease in Patients With Type 2 Diabetes
Mellitus: A Scientific Statement From the American Heart
Association. Circulation. 2020;141(19):e779‐e806.
doi:10.1161/CIR.0000000000000766
2 Fan W, Philip S, Granowitz C, Toth PP, Wong ND. Residual
Hypertriglyceridemia and Estimated Atherosclerotic Cardiovascular
Disease Risk by Statin Use in U.S. Adults With Diabetes: National
Health and Nutrition Examination Survey 2007-2014. Diabetes Care.
2019;42(12):2307‐2314.
3 Rana JS, Liu JY, Moffet HH, et al. Metabolic dyslipidemia and
risk of coronary heart disease in 28,318 adults with diabetes
mellitus and low-density lipoprotein cholesterol <100 mg/dl. Am
J Cardiol. 2015;116:1700-1704.
4 Nichols GA, Philip S, Reynolds K, Granowitz CB, Fazio S.
Increased residual cardiovascular risk in patients with diabetes
and high versus normal triglycerides despite statin-controlled LDL
cholesterol. Diabetes Obes Metab. 2019;21(2):366‐371.
5 American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139–e596.
6 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.
7 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
8 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.
9 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
10 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.
11 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.
12 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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