Higher Rates of Myocardial Infarction
(Heart Attack) and Revascularization Procedures in Patients with
High Triglycerides Were Drivers of the Composite
Outcome
Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular (CV) health, presented
a real-world data analysis today revealing that patients with high
triglycerides, despite controlled LDL (bad) cholesterol, were at
significantly greater risk for major adverse cardiovascular events
(MACE). The patients studied also incurred higher healthcare costs
than those with normal triglyceride levels. The analysis was
presented at the 2017 American Heart Association (AHA) Scientific
Sessions in Anaheim, CA.
The study, “High Triglycerides Increase
Cardiovascular Events, Medical Costs, and Resource Utilization in a
Real-World Analysis of Statin-Treated Patients with High
Cardiovascular Risk and Well-Controlled Low-Density Lipoprotein
Cholesterol,” was based on a retrospective analysis of
de-identified claims. The database utilized for the analysis had
millions of de-identified medical records from patient experience
within a leading national information and technology-enabled health
services business. The study analyzed two adult cohorts with statin
use, controlled LDL-C, and with either established atherosclerotic
cardiovascular disease (ASCVD) or with diabetes mellitus and
additional CV risk factors: those with high triglycerides (200-499
mg/dL) and those with normal triglycerides (<150 mg/dL),
N=10,990 per cohort. The majority of patients did not have
established atherosclerotic cardiovascular disease (primary
prevention).
Over an average follow-up of 41 to 42 months,
ASCVD patients with high TGs, as compared with the normal TG group,
were at increased risk of cardiovascular outcomes after
multivariable adjustment as follows:
- 35% increased risk for myocardial infarction (95% CI
1.19-1.52)
- 51% increased risk for coronary revascularization (95% CI
1.34-1.69)
- 35% higher rate of occurrence of a major adverse CV event
(MACE) (95% CI 1.23-1.49)
Composite outcome = nonfatal MI, nonfatal
stroke, coronary revascularization, unstable angina, or CV-related
mortality
In addition, the high TG cohort had nearly a 15%
higher average total health care cost and 17% higher rate of
occurrence of an inpatient stay over time. Both study cohorts were
predominantly comprised of primary prevention patients as only 29%
of subjects had established atherosclerotic cardiovascular disease.
This study analyzed health data of real-world patients and was not
a prospective analysis of medical intervention.
The authors of this study were Peter P. Toth,
CGH Medical Center, Sterling, IL; Craig Granowitz, Amarin Pharma,
Inc., Bedminster, NJ; Michael Hull, Djibril Liassou, Amy Anderson,
Optum, Eden Prairie, MN; Sephy Philip, Amarin Pharma, Inc.,
Bedminster, NJ.
Potential limitations of real-world data
analysis include the observational, retrospective nature of the
study which can add to uncertainty regarding findings as compared
to prospectively collected data, the potential for inaccurate
recording of health events in the database and missing data which
may limit the usefulness of the findings. Without further study,
the extent, if any, that a biomarker such as triglyceride levels is
causally related to the clinical events cannot be determined.
“These data highlight the increased
cardiovascular risk and healthcare cost in subjects with high
triglyceride levels despite statin use and controlled LDL-C in a
real-world setting and a large sample of patient experience over
multiple years,” expressed Peter Toth, MD, PhD. “The ongoing
REDUCE-IT cardiovascular outcomes study will prospectively
determine whether treatment with Vascepa® provides benefit for high
CV risk patients with persistent high triglycerides despite statin
controlled LDL-C. If positive, the results of the REDUCE-IT
study could provide a pragmatic care solution for the treatment of
many at-risk patients.”
About REDUCE-IT
Amarin's clinical development program for
Vascepa includes a trial known as the REDUCE-IT cardiovascular
outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT
is the first multinational cardiovascular outcomes study evaluating
the effect of prescription pure EPA therapy, or any
triglyceride-lowering therapy, as an add-on to statins in patients
with high cardiovascular risk who, despite stable statin therapy,
have elevated triglyceride levels (150 mg/dL to 499 mg/dL). A large
portion of the male and female patients enrolled in this outcomes
study are anticipated to also be diagnosed with type 2
diabetes. Amarin expects that the onset of the target
final primary cardiovascular event will be reached before the end
of Q1 2018, with results announced before the end of Q3
2018.
Additional information on clinical studies of
Vascepa can be found at www.clinicaltrials.gov.
About Amarin
Amarin Corporation plc is a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health. Amarin's
product development program leverages its extensive experience in
lipid science and the potential therapeutic benefits of
polyunsaturated fatty acids. Amarin's clinical program includes a
commitment to an ongoing outcomes study. Vascepa® (icosapent
ethyl), Amarin's first FDA approved product, is a highly-pure,
omega-3 fatty acid product available by prescription. For
more information about Vascepa visit www.vascepa.com. For more
information about Amarin visit www.amarincorp.com.
About Vascepa® (icosapent ethyl)
capsules
Vascepa® (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not fish oil,
but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient. Vascepa is known in scientific literature as
AMR101. Amarin has been issued multiple patents
internationally based on the unique clinical profile of Vascepa,
including the drug’s ability to lower triglyceride levels in
relevant patient populations without raising LDL-cholesterol
levels.
FDA-Approved Indication and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to
reduce triglyceride (TG) levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and
cardiovascular mortality and morbidity in patients with severe
hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of
its components.
- Use with caution in patients with known hypersensitivity to
fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2%
and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0%
for placebo). There was no reported adverse reaction > 3% and
greater than placebo.
- Patients receiving treatment with Vascepa and other drugs
affecting coagulation (e.g., anti-platelet agents) should be
monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- Patients should be advised to swallow Vascepa capsules whole;
not to break open, crush, dissolve, or chew Vascepa.
- Adverse events and product complaints may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE
FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United
States Food and Drug Administration (FDA) as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Nothing in this press release should
be construed as promoting the use of Vascepa in any indication that
has not been approved by the FDA.
Forward-looking statements
This press release contains statements related
to scientific presentations from real-world evidence and other
studies.These statements are not promises or guarantees related to
the potential for favorable outcomes from the ongoing REDUCE-IT
cardiovascular outcomes trial. As disclosed in filings with the
U.S. Securities and Exchange Commission, Amarin's ability to
effectively develop and commercialize Vascepa will depend in part
on its ability to continue to effectively finance its business,
efforts of third parties, its ability to create market demand for
Vascepa through education, marketing and sales activities, to
achieve increased market acceptance of Vascepa, to receive adequate
levels of reimbursement from third-party payers, to develop and
maintain a consistent source of commercial supply at a competitive
price, to comply with legal and regulatory requirements in
connection with the sale and promotion of Vascepa and to maintain
patent protection for Vascepa. 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, clinical trials and
related regulatory approvals; the risk that future legal
determinations and interactions with regulatory authorities may
impact Vascepa marketing and sales rights and efforts; the risk
that Vascepa may not show clinically meaningful effects in
REDUCE-IT or support regulatory approvals for cardiovascular risk
reduction; and the risk that patents may not be upheld in
anticipated patent litigation. 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.
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
(http://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
InformationInvestor Relations:
Elisabeth Schwartz Investor Relations and Corporate
Communications Amarin Corporation plc In U.S.: +1 (908)
719-1315 investor.relations@amarincorp.com
Lee M. Stern Trout Group In U.S.: +1 (646) 378-2992
lstern@troutgroup.com
Media Inquiries: Ovidio Torres Finn Partners In U.S.: +1
(312) 329-3911 Ovidio.torres@finnpartners.com
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