Esperion (NASDAQ: ESPR) today announced publication of updated
recommendations from the ILEP which advance bempedoic acid
utilization in front of injectable PCSK9 inhibitors. The article,
entitled “Bempedoic acid in the management of lipid disorders and
cardiovascular risk. 2023 position paper of the international lipid
expert panel (ILEP),” was published in Progress in Cardiovascular
Disease and can be found here.
“This is only the beginning of the broader acceptance and
utilization of NEXLETOL (bempedoic acid) Tablets and NEXLIZET
(bempedoic acid and ezetimibe) Tablets both globally, and in the
U.S., and the paradigm shift we were expecting,” said Sheldon
Koenig, president and chief executive officer of Esperion. “We are
encouraged by the positive feedback on our recent late-breaker at
the American College of Cardiology’s Annual Scientific Session
& Expo together with the World Congress of Cardiology
(ACC23/WCC) presentation and simultaneous publication in the New
England Journal of Medicine just four days ago. The significant
enthusiasm we have received from the medical, patient and payer
communities highlights the relevance of the data from CLEAR
Outcomes to real-world clinical practice and signals the potential
for rapid adoption. We expect the ILEP recommendation to be a
precursor to additional treatment guideline updates both in the
U.S. and abroad.”
In 2022, the ILEP published recommendations on management of
partial or complete statin intolerant patients, utilizing both
ezetimibe and PCSK9i therapy ahead of bempedoic acid. Based on the
robustness of the CLEAR Outcomes results, the ILEP now recommends
bempedoic acid utilization ahead of PSCK9i therapy, either in
combination or after ezetimibe treatment. Highlights from the ILEP
recommended pathways on the use of bempedoic acid in patients with
very high cardiovascular risk are summarized below:
Key ILEP Recommendations in Secondary Prevention
Patients
- In ASCVD/HeFH patients with baseline LDL-C 110-160 mg/dl,
utilize an upfront combination of high intensity statin and
ezetimibe, and if LDL-C is still > 55 mg/dl, start with
bempedoic acid. If patient LDL-C is still > 55 mg/dl start with
PCSK9i targeted therapy, if available.
- In ASCVD/HeFH patients with baseline LDL-C >160 mg/dl,
utilize an upfront combination of high intensity statin and fixed
dose combination of bempedoic acid and ezetimibe, and if LDL-C is
still > 55 mg/dl, start with PCSK9i targeted therapy, if
available.
Key ILEP Recommendations in Primary Prevention
Patients
- In very high-risk patients with partial statin intolerance,
utilize an upfront combination of high intensity statin and
ezetimibe, and if LDL-C is still > 55 mg/dl, start with
bempedoic acid. If patient LDL-C is still > 55 mg/dl start with
PCSK9i targeted therapy, if available.
- In very high-risk patients with complete statin intolerance,
utilize an upfront combination of bempedoic acid and ezetimibe, and
if LDL-C is still > 55 mg/dl, start with PCSK9i targeted
therapy, if available.
“Achieving cholesterol goals for those at highest risk continues
to be a vexing problem,” noted Kausik Ray, BSc (hons), MBChB, FRCP
(Lon), FRCP (Ed), MD, MPhil (Cantab), FACC, FESC, FAHA, Professor
of Public Health and Honorary Cardiologist at Imperial College
London, and President of the European Atherosclerosis Society.
“With an increasing awareness that achieving LDL cholesterol goals
for those at highest risk is not feasible through statin
monotherapy, increasingly pragmatic guidance is being sought. Cost
limits uptake of injectable therapies. Whilst statins and ezetimibe
are a good start many will remain above 55 mg/dl. This updated ILEP
now firmly places the evidence-based treatment bempedoic acid
before injectables where cost in particular is an issue.”
CLEAR Cardiovascular Outcomes Trial CLEAR
Outcomes is a Phase 3, event-driven, randomized, multicenter,
double-blind, placebo-controlled trial designed to evaluate whether
treatment with NEXLETOL reduces the risk of cardiovascular events
in patients with or who are at high risk for cardiovascular disease
with documented statin intolerance (inability to tolerate 2 or more
statins, one at a low dose) and elevated LDL-C levels (fasting
blood LDL-C ≥ 100 (2.6 mmol/L). The study, which includes nearly
14,000 patients at over 1,200 sites in 32 countries, accumulated
the targeted 1,620 primary major adverse cardiovascular events
(MACE-4) in August 2022.
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 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 Twitter at 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 expected operational expenses, expected
revenue of our commercial products, future operations, expected
milestone payments from partners, commercial products and expected
growth, clinical development and regulatory submissions, 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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