Esperion (NASDAQ: ESPR) today announced that the landmark
Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen
(CLEAR) Outcomes trial, which met its primary endpoint, has been
accepted as a late-breaking clinical trial at ACC.23/WCC based on
the impact and novelty of the research; rigor of the
design/methods; major clinical endpoints; and the quality of the
statistical plan.
CLEAR Outcomes kicks off the Late-Breaking Clinical Trial
sessions in the Great Hall in New Orleans and will stream live on
the ACC.23/WCC virtual platform, commencing at 9:30 AM Central Time
on March 4, 2023. Esperion is eager to share CLEAR Outcomes
data in greater detail with the overall scientific community and
regulatory authorities.
“On behalf of the entire Esperion team, we are pleased to
present the practice-changing results from our innovative and
unprecedented outcomes trial to the medical and scientific
community at ACC,” said Sheldon Koenig, Esperion’s president and
chief executive officer. “Patients who are unable to tolerate or
reach their goals with statins have increased risk for adverse
cardiovascular outcomes. With these positive outcomes data,
bempedoic acid, the active ingredient in NEXLETOL® (bempedoic acid)
and NEXLIZET® (bempedoic acid and ezetimibe), becomes the first
oral non-statin to meet the MACE-4 primary endpoint and one of the
few oral options to not only reduce LDL-C but also cardiovascular
risk. Considered against the backdrop of multiple recent
unsuccessful cardiovascular outcomes studies, these results
indicate that bempedoic acid provides broad cardiovascular risk
reduction on top of significant LDL-C control for patients. Since
releasing the positive topline results, we have fielded
enthusiastic inquiries from health care providers and scientific
leaders which we believe predicts strong prospects for brand
growth,” he concluded.
CLEAR Outcomes is a Phase 3, event-driven, randomized,
multicenter, double-blind, placebo-controlled trial designed to
evaluate whether treatment with bempedoic acid reduces the risk of
cardiovascular events in patients with or who are at high risk for
cardiovascular disease, unable to maximize or tolerate a statin
(inability to tolerate two or more statins, one at a low dose) and
elevated LDL-cholesterol levels (fasting blood LDL-C ≥ 100 (2.6
mmol/L)). The study included over 14,000 patients at over 1,200
sites in 32 countries.
INDICATIONNEXLETOL and NEXLIZET are indicated
as adjuncts to diet and maximally tolerated statin therapy for the
treatment of adults with heterozygous familial hypercholesterolemia
or established atherosclerotic cardiovascular disease who require
additional lowering of LDL-C. Limitations of Use: The effect of
NEXLETOL and NEXLIZET on cardiovascular morbidity and mortality has
not been determined.
IMPORTANT SAFETY
INFORMATIONContraindications: NEXLETOL
has no contraindications. NEXLIZET is contraindicated in patients
with a known hypersensitivity to ezetimibe tablets.
Hypersensitivity reactions including anaphylaxis, angioedema, rash,
and urticaria have been reported with ezetimibe.
Warnings and Precautions: Hyperuricemia:
Bempedoic acid, a component of NEXLETOL and NEXLIZET, may increase
blood uric acid levels. Hyperuricemia may occur early in treatment
and persist throughout treatment, and may lead to the development
of gout, especially in patients with a history of gout. 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
is associated with an increased risk of tendon rupture or injury.
In clinical trials, tendon rupture occurred in 0.5% of patients
treated with bempedoic acid versus 0% of patients treated with
placebo, and involved the rotator cuff (the shoulder), biceps
tendon, or Achilles tendon. Tendon rupture occurred within weeks to
months of starting bempedoic acid. Tendon rupture may occur more
frequently in patients over 60 years of age, patients taking
corticosteroid or fluoroquinolone drugs, patients with renal
failure, and patients with previous tendon disorders. Discontinue
NEXLETOL or NEXLIZET at the first sign of tendon rupture. Avoid
NEXLETOL and NEXLIZET in patients who have a history of tendon
disorders or tendon rupture.
Adverse Reactions: In NEXLETOL
clinical trials, the most commonly reported adverse reactions were
upper respiratory tract infection, muscle spasms, hyperuricemia,
back pain, abdominal pain or discomfort, bronchitis, pain in
extremity, anemia, and elevated liver enzymes. Reactions reported
less frequently, but still more often than with placebo, included
benign prostatic hyperplasia and atrial fibrillation.In the
NEXLIZET clinical trial, the most commonly reported adverse
reactions observed with NEXLIZET, but not observed in clinical
trials of bempedoic acid or ezetimibe, a component of NEXLIZET, and
occurring more frequently than with placebo, were urinary tract
infection, nasopharyngitis, and constipation.Adverse reactions
reported in clinical trials of ezetimibe, and occurring at an
incidence greater than with placebo, included upper respiratory
tract infection, diarrhea, arthralgia, sinusitis, pain in
extremity, fatigue, and influenza. Other adverse reactions reported
in postmarketing use of ezetimibe included hypersensitivity
reactions, including anaphylaxis, angioedema, rash, and urticaria;
erythema multiforme; myalgia; elevated creatine phosphokinase;
myopathy/rhabdomyolysis; elevations in liver transaminases;
hepatitis; abdominal pain; thrombocytopenia; pancreatitis; nausea;
dizziness; paresthesia; depression; headache; cholelithiasis;
cholecystitis.Drug Interactions: Simvastatin and
Pravastatin: Concomitant use with bempedoic acid results in
increased concentrations and increased risk of simvastatin or
pravastatin-related myopathy. Use of either NEXLETOL or NEXLIZET
with greater than 20 mg of simvastatin or 40 mg of pravastatin
should be avoided.Cyclosporine: Caution should be exercised when
using NEXLIZET and cyclosporine concomitantly due to increased
exposure to both ezetimibe and cyclosporine. Monitor cyclosporine
concentrations in patients receiving NEXLIZET and cyclosporine. In
patients treated with cyclosporine, the potential effects of the
increased exposure to ezetimibe from concomitant use should be
carefully weighed against the benefits of alterations in lipid
levels provided by
NEXLIZET.Fibrates:
Coadministration of NEXLIZET with fibrates other than fenofibrate
is not recommended. Fenofibrate and ezetimibe may increase
cholesterol excretion into the bile, leading to cholelithiasis. If
cholelithiasis is suspected in a patient receiving NEXLIZET and
fenofibrate, gallbladder studies are indicated and alternative
lipid-lowering therapy should be considered.Cholestyramine:
Concomitant use of NEXLIZET and cholestyramine decreases ezetimibe
concentration. This may result in a reduction of efficacy.
Administer NEXLIZET either at least 2 hours before, or at least 4
hours after, bile acid sequestrants.
Lactation and Pregnancy: It is not recommended
that NEXLETOL or NEXLIZET be taken during breastfeeding.
Discontinue NEXLETOL or NEXLIZET when pregnancy is recognized,
unless the benefits of therapy outweigh the potential risks to the
fetus. Based on the mechanism of action of bempedoic acid, NEXLETOL
and NEXLIZET may cause fetal harm.
Please see full Prescribing Information here.
Esperion TherapeuticsEsperion works hard to
make our medicines easy to get, easy to take, and easy to have. We
discover, develop, and commercialize innovative medicines and
combinations to lower cholesterol, especially for patients whose
needs aren’t being met by the status quo. Our entrepreneurial team
of industry leaders is inclusive, passionate and resourceful. We
are singularly focused on managing cholesterol so you can improve
your health easily. For more information, please visit esperion.com
and follow us on Twitter at www.twitter.com/EsperionInc.
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 future operations, commercial products and
expected growth, clinical development, 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 impact of the ongoing
COVID-19 pandemic on our business, revenues, results of operations
and financial condition, the net sales, profitability, and growth
of Esperion’s commercial products, clinical activities and results,
supply chain, commercial development and launch plans, 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.
Contact:Esperion Corporate
Communicationscorporateteam@esperion.com
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