Unique Community-Based Partnership With the
Association of Black Cardiologists and Morehouse School of Medicine to Identify Study
Sites and Participants
Observational Study to Better Understand
Associations Between Lp(a) Levels and Atherosclerotic
Cardiovascular Disease (ASCVD) in an Underrepresented Patient
Population
THOUSAND
OAKS, Calif., Feb. 22,
2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced the African American Heart Study, in collaboration with
the Association of Black Cardiologists (ABC) and the Morehouse School of Medicine (MSM), which will
measure the association between Lipoprotein(a), or Lp(a), and
atherosclerotic cardiovascular disease (ASCVD) in 5,000 African
American individuals across the United
States. ASCVD is defined as the buildup of cholesterol
plaque in arteries and includes events such as heart attack and
stroke.
"The African American Heart Study is a unique collaborative
study including community outreach in partnership with trusted
organizations to help improve our understanding of the
disproportionate higher incidence of Lp(a) and cardiovascular
disease progression in African Americans and hopefully provide
insights of ways to address barriers in clinical trial access,"
said Ponda Motsepe-Ditshego, M.D., vice president, global medical
and head of Amgen's Representation in Clinical Research team. "At
Amgen, our mission is to serve patients, and important to that
mission is expanding clinical trial access and diverse
representation in the community setting to provide a full picture
of how a disease impacts certain groups."
Cardiovascular disease is the number one killer of all
Americans, and the cardiovascular risk for African Americans is
even higher. According to the U.S. Department of Health and Human
Services, African Americans are 30% more likely to die from heart
disease than non-Hispanic whites.1-2
Lp(a) is a presumed independent risk factor for heart disease;
levels are genetically determined and are known to differ by
race and ethnicity.3-6 African American individuals show
a higher average Lp(a) concentration than white
populations, but Lp(a) research to date has primarily been
conducted in individuals of European descent.7 This
leaves the association between Lp(a) levels and incident ASCVD in
persons of African American descent uncertain and important to
investigate further to understand drivers of cardiovascular risk in
African Americans. Amgen has initiated the African American Heart
Study to bridge this gap.
"People of all races and ethnicities can have high levels of
Lp(a), but it appears to be more common in African Americans. I am
excited about the African American Heart Study because we have the
opportunity to study up to 5,000 self-identified African Americans,
who have been so often underrepresented in studies, in order to
gain a better understanding of the genetic underpinnings of Lp(a)
and to determine if African American patients are at a higher risk
of cardiovascular disease," said Elizabeth
Ofili, M.D., M.P.H., FACC, professor of medicine at
Morehouse School of Medicine and
principal investigator of the study. "The results of this study
will potentially provide insights that will help determine which
types of patients would benefit most from future therapy."
This prospective case-control study design will enroll 2,500
self-identified African Americans with ASCVD and 2,500
self-identified African Americans without ASCVD from cardiology and
primary care practices across the United
States. Enrollment is voluntary. ABC and MSM will conduct
community outreach, as well as identify sites through the Health
360x Clinical Trial Network and Registry. The Health 360x
Network practice sites are trusted providers, crucial to the
success of the African American Heart Study. The Health 360x
Clinical Trial Network and Registry is funded by the National
Institutes of Health to support clinical trials in community-based
practices.9
Amgen's subsidiary, deCODE genetics, based in Iceland, with its world-class human genetics
capabilities, will sequence and analyze DNA, RNA, and protein
markers from participants' blood samples. With three years of
follow-up planned, the broad omics data analyzed by deCODE will
help Amgen broaden the understanding of ASCVD and other diseases
that disproportionately affect African Americans. The learnings may
also inform future clinical trials and drug development.
"Increasing the diversity in our clinical trials is essential to
achieving our ambition of serving all patients. This requires us to
think differently than we have in the past about how we design and
conduct our trials," said Rob Lenz,
M.D., Ph.D., senior vice president, Global Development at Amgen.
"To do that, we are educating the community on why this is critical
and building trusted relationships with our partners. We also are
training external investigators and building new capabilities that
will help provide them with the right infrastructures in
communities of underserved patient populations to make projects
like the African American Heart Study possible."
The African American Heart Study is emblematic of Amgen's
unwavering commitment to diversity in clinical trials. In 2020,
Amgen launched its Representation in Clinical Research team to
accelerate its work in promoting diversity in clinical trials and
is focused on improving clinical trial diversity and proportional
representation by addressing the systemic issues that deter people
from participating in research, especially those who have been
historically excluded due to race, ethnicity, sex, age, and other
factors.
About the African American Heart Study
The main
objective of the study is to determine associations between Lp(a)
levels, sequence variants, clinical factors and cardiovascular
outcomes in African Americans. Participants will be followed for at
least three years leveraging real-world evidence from electronic
health records.
About Lp(a)
Lp(a) is genetically determined and
presumed to be an independent risk factor for cardiovascular
disease (CVD). 4-6 Although an agreed upon threshold for
elevated Lp(a) is not firmly established, it has been estimated
that approximately 20% of adults have Lp(a) >125 nmol/L (or
approximately 50 mg/dL).3-6 Evidence has emerged
from pathophysiological, epidemiologic, and genetic studies
on the potential role of elevated Lp(a) in contributing to
myocardial infarction, stroke, and peripheral arterial
disease.3-8
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one
of the world's leading independent biotechnology
companies, has reached millions of patients around the world and is
developing a pipeline of medicines with breakaway
potential.
Amgen is one of the 30 companies that comprise the Dow
Jones Industrial Average and is also part of the Nasdaq-100 index.
In 2022, Amgen was named one of the "World's Best
Employers" by Forbes and one of "America's 100 Most Sustainable
Companies" by Barron's.
For more information, visit Amgen.com and follow us on Twitter,
LinkedIn, Instagram, TikTok and YouTube.
About deCODE genetics
Based in Reykjavik, Iceland, deCODE genetics, is a
global leader in analyzing and understanding the human genome.
Using its unique expertise and population resources, deCODE has
discovered genetic risk factors for dozens of common diseases. The
purpose of understanding the genetics of disease is to use that
information to create new means of diagnosing, treating and
preventing disease. deCODE is a wholly-owned subsidiary of Amgen
(NASDAQ:AMGN).
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CONTACT: Amgen, Thousand Oaks
Michael Strapazon, 805-313-5553
(media)
Jessica Akopyan, 805-440-5721
(media)
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(investors)
1 American
Heart Association. African Americans and Heart Disease, Stroke.
Available at:
https://www.heart.org/en/health-topics/consumer-healthcare/what-is-cardiovascular-disease/african-americans-and-heart-disease-stroke.
Last accessed: February 9, 2023.
|
2 CDC.
Lipoprotein (a). Available at:
https://www.cdc.gov/genomics/disease/lipoprotein_a.htm#:~:text=High%20levels%20of%20lipoprotein%20(a,made%
20of%20protein%20and%20fat. Last accessed: February 9,
2023.
|
3 Wilson DP, et al. Clin
Lipidol. 2019;13:374-92.
|
4 Reyes-Soffer G, et al.
Arterioscler Thromb Vasc Biol. 2022;42:e48-e60.
|
5 Tsimikas
S, et al. J Am Coll Cardiol. 2018;71:177-192.
|
6 Kronenberg F, et al. Eur Heart
J. 2022; 43:3935-3946.
|
7 Tsimikas
S, et al. J Am Coll Cardiol. 2022;80:934-946.
|
8 Tsmikas S, et al. J Am Coll
Cardiol. 2017;69:692-711.
|
9 Health 360x Clinical Research
Platform for Scalable Access to Clinical Trials is funded by the
National Center for Advancing Translational Science, National
Institutes of Health, Small Business Innovation Research Award #
5R44TR003832 (PI Chamberlain Obialo, MD, AccuHealth Technologies
Inc.) The content of the Press Release is solely the responsibility
of the authors and does not necessarily represent the official
views of the National Institutes of Health.
|
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