Esperion (NASDAQ: ESPR) today announced the peer reviewed
publication of the key design paper outlining the baseline
characteristics of the enrolled patient population, rationale and
design of the CLEAR Outcomes trial evaluating NEXLETOL® (bempedoic
acid) Tablet in patients with documented statin intolerance, the
first and only cardiovascular outcomes trial (CVOT) to exclusively
study this patient population at high risk of cardiovascular
disease (CVD), in the May 2021 issue of the American Heart Journal.
“The CLEAR Outcomes CVOT represents a landmark trial, as it is
the first LDL-C [low-density lipoprotein cholesterol] lowering CVOT
to be conducted in statin intolerant patients, an underserved
population with high cardiovascular risk and high baseline LDL-C1,”
said Ashley Hall, Chief Development Officer at Esperion. “Another
significant aspect of this trial is that historically women are
underrepresented in CVOTs; however, women make up nearly half
of the participants enrolled in CLEAR Outcomes compared to
one-quarter of participants enrolled in past CVOT studies2. We are
very excited for the upcoming results from this trial.”
“Treatment of statin averse patients, like those enrolled in
CLEAR Outcomes, represents a major unmet medical need that affects
millions of patients,” said Stephen Nicholls, co-principal
investigator of CLEAR Outcomes, and Director of MonashHeart and
Victorian Heart Institute. “The trial focuses on these patients,
and is well represented with women, who are historically
understudied in clinical trials, and patients with high baseline
LDL-C (on average 139 mg/dL at baseline); this landmark trial could
potentially give us more options to lower their risk of
cardiovascular disease, as well as data to better understand their
needs.”
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
CVD with documented statin intolerance and elevated LDL-C
levels.
The primary endpoint of the study is the effect of NEXLETOL on
four-component major adverse cardiovascular events, or MACE
(cardiovascular death, nonfatal myocardial infarction, nonfatal
stroke, or coronary revascularization). The study, which was fully
enrolled in August 2019, includes over 14,000 patients at over
1,200 sites in 32 countries. Additionally, CLEAR Outcomes has
enrolled about 6,000 patients (~42%) with diabetes, with potential
to further understand the impact of bempedoic acid on glycemic
control3-4.
CLEAR Outcomes is designed to provide 90 percent power to detect
an approximately 15 percent relative risk reduction in the primary
endpoint in the bempedoic acid treatment group as compared to the
placebo group. The trial is expected to complete with a minimum of
1,620 patients with an estimated median treatment duration of 3.5-4
years. This duration is considerably longer (over a year) than
other recently completed CVOT’s and therefore, this study is
anticipated to provide a thorough representation of the
benefit-risk profile of bempedoic acid on key cardiovascular
endpoints. Based on currently estimated MACE event rates, the CLEAR
Outcomes trial is estimated to reach the target number of MACE
primary endpoints in the second half of 20223-4.
The 2020 approval of NEXLETOL in the U.S. was supported by a
global pivotal Phase 3 LDL-C-lowering program conducted in more
than 3,000 patients with atherosclerotic cardiovascular disease
(ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH).
In these studies, NEXLETOL provided an average of 18%
placebo-corrected LDL-C lowering at week 12 when used with
maximally tolerated statins. The most common (incidence ≥2% and
greater than placebo) 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. NEXLETOL is indicated as an adjunct to diet
and maximally tolerated statin therapy for the treatment of adults
with HeFH or established ASCVD who require additional lowering of
LDL-C. The effect of bempedoic acid on cardiovascular morbidity and
mortality has not been determined1. Please see important safety
information below.
NEXLETOL® (bempedoic
acid) Tablet
Indication NEXLETOL is indicated as an adjunct 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 on
cardiovascular morbidity and mortality has not been determined.
Important Safety Information
Warnings and Precautions:
- Hyperuricemia: NEXLETOL 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: NEXLETOL is associated with an increased risk
of tendon rupture or injury. In clinical trials, tendon rupture
occurred in 0.5% of patients treated with NEXLETOL 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 NEXLETOL. 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 at the first sign of tendon rupture. Avoid
NEXLETOL in patients who have a history of tendon disorders or
tendon rupture.
Adverse Reactions:
- In 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.
Drug Interactions:
- Simvastatin and Pravastatin: Concomitant use results in
increased concentrations and increased risk of simvastatin or
pravastatin-related myopathy. Use with greater than 20 mg of
simvastatin or 40 mg of pravastatin should be avoided.
Lactation and Pregnancy: It is not recommended that NEXLETOL be
taken during breastfeeding. Discontinue NEXLETOL when pregnancy is
recognized unless the benefits of therapy outweigh the potential
risks to the fetus. Based on the mechanism of action, NEXLETOL may
cause fetal harm.
You are encouraged to report negative side effects of
prescription drugs to the
FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088 or report side effects to Esperion at
833-377-7633 (833 ESPRMED).
Please see the full Prescribing Information for
NEXLETOL.
Esperion Therapeutics
ESPERION is The Lipid Management Company. Our goal is lipid
management for everybody, that’s why we work 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 www.esperion.com and follow us on
Twitter at www.twitter.com/EsperionInc.
ESPERION Therapeutics’ Commitment to Patients with
Hyperlipidemia
High levels of LDL-C can lead to a build-up of fat and
cholesterol in and on artery walls (known as atherosclerosis),
potentially leading to cardiovascular events, including heart
attack and stroke. In the U.S., 96 million people, or more than 37
percent of the adult population, have elevated LDL-C. There are
approximately 18 million people in the U.S. living with elevated
levels of LDL-C despite taking maximally tolerated lipid-modifying
therapy — including individuals considered statin averse — leaving
them at high risk for cardiovascular events5. In the United States,
more than 50 percent of atherosclerotic cardiovascular disease
(ASCVD) patients and heterozygous familial hypercholesterolemia
(HeFH) patients who are not able to reach their guideline
recommended LDL-C levels with statins alone need less than a 40
percent reduction to reach their LDL-C threshold goal6.
ESPERION’s mission as the Lipid Management Company is to deliver
oral, once-daily medicines that complement existing oral drugs to
provide the additional LDL-C lowering that these patients need.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding commercialization
plans for bempedoic acid tablet. 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, delays or failures
in Esperion’s clinical development and commercialization plans, or
approval of expanded indications, that existing cash resources may
be used more quickly than anticipated, the impact of COVID-19 on
our business, clinical activities and commercial development 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.
References
(1) Nicholls SJ, Lincoff M, Bays HE, et al. Rationale and
design of the CLEAR-outcomes trial: Evaluating the effect of
bempedoic acid on cardiovascular events in patients with statin
intolerance. Am Heart J. 2021; 235:104-112.
https://doi.org/10.1016/j.ahj.2020.10.060
(2) Cholesterol Treatment Trialists’ (CTT) Collaboration,
Baigent C, Blackwell L, Emberson J, et al. Efficacy and safety of
more intensive lowering of LDL cholesterol: a meta-analysis of data
from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov
13;376(9753):1670-81.
https://www.thelancet.com/article/S0140-6736(10)61350-5/fulltext.
Epub 2010 Nov 8. PMID: 21067804; PMCID: PMC2988224.
(3) Sabatine MS, Giugliano RP, Keech A, et al. Rationale and
design of the Further cardiovascular Outcomes Research with PCSK9
Inhibition in subjects with Elevated Risk trial. Am Heart J. 2016;
173:94-101. doi: 10.1016/j.ahj.2015.11.015 (patients 75.4%
male).
(4) Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and
Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med
2018; 379:2097-2107. DOI: 10.1056/NEJMoa1801174 (patients 74.8%
male).
(5) ESPERION market research on file: research project
interviewing 350 physicians. ESPERION Therapeutics, Inc. Sept-Oct
2018.
(6) Data on file: analysis of NHANES database. ESPERION
Therapeutics, Inc. 2018.
Supporting content: social media
TwitterTweet Copy: #News:
CLEAR Outcomes study rationale and design in patients with
documented statin-intolerance was highlighted in the latest issue
of @AmericanHeartJ. Learn more: [Include bit.ly link to press
release] #cholesterol
Graphic Copy: A landmark outcomes trial
designed to assess cardiovascular risk reduction in patients with
documented intolerance to statin therapy.
LinkedInPost Copy: As many as
20% of individuals with high cholesterol can’t or won’t take
statins, putting them at increased risk of cardiovascular disease.
Despite this, these patients have never been the focus of a
cardiovascular outcomes study.
The rationale and design of our landmark CLEAR Outcomes study in
patients with documented statin-intolerance was featured in the May
issue of the American Heart Journal. Learn more: [Include bit.ly
link to press release]
Graphic Copy: A landmark outcomes trial
designed to assess cardiovascular risk reduction in patients with
documented intolerance to statin therapy.
Contact:Kaitlyn Brosco Esperioncorporateteam@esperion.com
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