Esperion (Nasdaq: ESPR) today announced the presentation of results
from three pre-specified subgroups from CLEAR Outcomes at the 2024
American College of Cardiology’s Annual Scientific Sessions
(ACC.24): women, Hispanic/Latinx, and patients with obesity. These
results align with the American College of Cardiology’s robust
diversity, equity and inclusion programs to drive cultural change
across the profession and ensure that the cardiovascular care team
is as diverse as the patients they care for and that all patients
are represented in cardiovascular research. The data also reinforce
the mission of the ACC: transforming cardiovascular care for all.
“These analyses showcase the benefit of NEXLETOL and the
bempedoic acid component of NEXLIZET® (bempedoic acid and
ezetimibe) Tablets in several important yet often understudied
populations,” said JoAnne Foody, MD, FACC, FAHA, Chief Medical
Officer of Esperion. “Bempedoic acid is the only FDA approved
non-statin LDL lowering therapy to demonstrate reductions in MACE
in both primary prevention and secondary prevention patient
populations. In women and Hispanic/Latinx patients with or at risk
for CVD, bempedoic acid decreased LDL-cholesterol (LDL-C) and
inflammatory markers, did not worsen glucose or weight, and in turn
reduced the risk of major adverse cardiovascular events (MACE).
These results continue to reinforce the importance of early and
aggressive LDL-C lowering in order to reduce cardiovascular events,
underscoring the paradigm of ‘even lower, even earlier is even
better.’”
Harold Bays, MD, FOMA, FTOS, FACC, FNLA, FASPC, Louisville
Metabolic and Atherosclerosis Research Center, University of
Louisville School of Medicine, presented “Bempedoic Acid
for Prevention of Cardiovascular Events in Patients with Obesity: A
CLEAR Outcomes Subset Analysis.” Nearly 45% of patients in
CLEAR Outcomes had obesity (body mass index greater than or equal
to 30 kg/m2) at the start of the study. In this analysis, patients
with obesity treated with bempedoic acid were 23% less likely to
experience MACE-4 (cardiovascular (CV) death, nonfatal myocardial
infarction (MI), nonfatal stroke, or coronary revascularization)
compared to placebo. “Given that obesity is an epidemic and a risk
factor for cardiovascular disease, clinicians and their patients
can make more informed therapeutic decisions upon knowing the CVD
outcomes among patients with obesity who receive specific
cardiometabolic therapies,” said Dr. Bays.
Fatima Rodriguez, MD, MPH, Stanford Medicine, presented
“Characteristics and Outcomes for Hispanic/Latinx
Participants with Statin Intolerance Receiving Bempedoic Acid:
Results from a CLEAR Outcomes Pre-Specified Subgroup
Analysis.” Hispanic/Latinx patients represented almost 17%
of those enrolled in the CLEAR Outcomes trial. The Hispanic
population is the largest ethnic minority in the U.S., yet is a
population historically underrepresented in clinical trials. This
subgroup analysis showed a similar 21% lowering of LDL-C with
bempedoic acid compared to placebo in Hispanic/Latinx and
non-Hispanic/Latinx alike, confirming the CV risk reduction benefit
of LDL-C lowering and the high tolerability of bempedoic acid,
regardless of ethnicity. This analysis was published in the Journal
of the American College of Cardiology (JACC).
Leslie Cho, MD, Cleveland Clinic, presented
“Characteristics and Outcomes for Statin-Intolerant Women
Receiving Bempedoic Acid in the CLEAR Outcomes Trial.”
CLEAR Outcomes is notable for the highest percentage enrollment
(48%) of females among contemporary lipid-lowering cardiovascular
outcomes trials. In the CLEAR Outcomes trial, the risk of MACE-4
was similarly reduced for women treated with bempedoic acid
compared to placebo, thus confirming its LDL-C lowering benefit on
CV risk reduction, regardless of sex. This analysis was
simultaneously published in Circulation.
INDICATION NEXLIZET and NEXLETOL are
indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is
indicated to reduce the risk of myocardial infarction and coronary
revascularization in adults who are unable to take recommended
statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination with other LDL-C lowering
therapies, to reduce LDL-C in adults with primary hyperlipidemia,
including HeFH.
- NEXLETOL, in combination with other LDL-C lowering therapies,
or alone when concomitant LDL-C lowering therapy is not possible,
to reduce LDL-C in adults with primary hyperlipidemia, including
HeFH.
IMPORTANT SAFETY INFORMATION NEXLIZET and
NEXLETOL are contraindicated in patients with a prior
hypersensitivity to bempedoic acid or ezetimibe or any of the
excipients. Serious hypersensitivity reactions including
anaphylaxis, angioedema, rash, and urticaria have been
reported.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and
NEXLETOL, may increase blood uric acid levels, which may lead to
gout. Hyperuricemia may occur early in treatment and persist
throughout treatment, returning to baseline following
discontinuation of treatment. Assess uric acid levels periodically
as clinically indicated. Monitor for signs and symptoms of
hyperuricemia, and initiate treatment with urate-lowering drugs as
appropriate.
Tendon Rupture: Bempedoic acid, a component of NEXLIZET and
NEXLETOL, is associated with an increased risk of tendon rupture or
injury. Tendon rupture may occur more frequently in patients over
60 years of age, in those taking corticosteroid or fluoroquinolone
drugs, in patients with renal failure, and in patients with
previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the
first sign of tendon rupture. Consider alternative therapy in
patients who have a history of tendon disorders or tendon
rupture.
The most common adverse reactions in the primary hyperlipidemia
trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in
≥2% of patients and greater than placebo were upper respiratory
tract infection, muscle spasms, hyperuricemia, back pain, abdominal
pain or discomfort, bronchitis, pain in extremity, anemia, and
elevated liver enzymes.
Adverse reactions reported in ≥2% of patients treated with
ezetimibe (a component of NEXLIZET) and at an incidence greater
than placebo in clinical trials were upper respiratory tract
infection, diarrhea, arthralgia, sinusitis, pain in extremity,
fatigue, and influenza.
In the primary hyperlipidemia trials of NEXLIZET, the most
commonly reported adverse reactions (incidence ≥3% and greater than
placebo) observed with NEXLIZET, but not observed in clinical
trials of bempedoic acid or ezetimibe, were urinary tract
infection, nasopharyngitis, and constipation.
The most common adverse reactions in the cardiovascular outcomes
trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at
an incidence of ≥2% and 0.5% greater than placebo were
hyperuricemia, renal impairment, anemia, elevated liver enzymes,
muscle spasms, gout, and cholelithiasis.
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized
unless the benefits of therapy outweigh the potential risks to the
fetus. Because of the potential for serious adverse reactions in a
breast-fed infant, breastfeeding is not recommended during
treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event
reporting line at 1-833-377-7633.
Esperion Therapeutics At Esperion, we discover,
develop, and commercialize innovative medicines to help improve
outcomes for patients with or at risk for cardiovascular and
cardiometabolic diseases. The status quo is not meeting the health
needs of millions of people with high cholesterol – that is why our
team of passionate industry leaders is breaking through the
barriers that prevent patients from reaching their goals. Providers
are moving toward reducing LDL-cholesterol levels as low as
possible, as soon as possible; we provide the next steps to help
get patients there. Because when it comes to high cholesterol,
getting to goal is not optional. It is our life’s work. For more
information, visit esperion.com and esperionscience.com and follow
us on X at twitter.com/EsperionInc.
CLEAR Cardiovascular Outcomes Trial CLEAR
Outcomes is part of the CLEAR clinical research program for
NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and
ezetimibe) Tablet. The CLEAR Program seeks to generate important
clinical evidence on the safety and efficacy of bempedoic acid, a
first in a class ATP citrate lyase inhibitor contained in NEXLETOL
and NEXLIZET and its potential role in addressing additional
critical unmet medical needs. More than 60,000 people will have
participated in the program by the time of its completion. The
CLEAR Program includes 5 label-enabling Phase III studies as well
as other key Phase IV studies with the potential to reach more than
70 million people with or at risk for CVD based on elevated
LDL-C.
Forward-Looking StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements regarding marketing strategy and commercialization
plans, current and planned operational expenses, future operations,
commercial products, clinical development, including the timing,
designs and plans for the CLEAR Outcomes study and its results,
plans for potential future product candidates, financial condition
and outlook, including expected cash runway, and other statements
containing the words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,”
“potential,” “will,” “would,” “could,” “should,” “continue,” and
similar expressions. Any express or implied statements contained in
this press release that are not statements of historical fact may
be deemed to be forward-looking statements. Forward-looking
statements involve risks and uncertainties that could cause
Esperion’s actual results to differ significantly from those
projected, including, without limitation, the net sales,
profitability, and growth of Esperion’s commercial products,
clinical activities and results, supply chain, commercial
development and launch plans, the outcomes and anticipated benefits
of legal proceedings and settlements, and the risks detailed in
Esperion’s filings with the Securities and Exchange Commission. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Esperion disclaims any obligation
or undertaking to update or revise any forward-looking statements
contained in this press release, other than to the extent required
by law.
Esperion Contact Information:Investors: Alexis
Callahaninvestorrelations@esperion.com (406) 539-1762
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
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