Esperion to Present Key Science at the American Heart Association Scientific Sessions 2021
November 01 2021 - 4:01PM
Esperion (NASDAQ: ESPR) today announced the presentation of three
abstracts at the American Heart Association (AHA) Scientific
Sessions 2021 taking place on November 13-15, 2021.
AHA Scientific Sessions 2021
On Demand |
|
Session Type: |
Oral Presentation #266 |
Abstract Title: |
Factors Associated with Enhanced
Low-density Lipoprotein Cholesterol Lowering with Bempedoic Acid
Among Patients Enrolled in Phase 3 Studies |
Authors: |
Christie M. Ballantyne, MD;
Harold E. Bays, MD; Jeremy Smart, PharmD; Yang Zhang, PhD; Kausik
K. Ray, MD, MPhil |
|
|
Session Type: |
Oral Presentation #267 |
Abstract Title: |
Efficacy and Safety of Bempedoic
Acid in Patients with Metabolic Syndrome |
Authors: |
Michael D. Shapiro, DO, MCR; Pam
R. Taub, MD; Michael J. Louie, MD, MPH, MSc; Lei Lei, PhD; Christie
M. Ballantyne, MD |
|
|
Session Type: |
Oral Presentation #264 |
Abstract Title: |
Pharmacokinetics,
Pharmacodynamics, and Safety of Bempedoic Acid in a Phase 1
Clinical Trial in Healthy Japanese, Chinese, and White
Subjects |
Authors: |
Benny M. Amore, PhD; Rujun Teng,
MS; Jeffrey C. Hanselman, MS |
Bempedoic Acid
INDICATIONBempedoic acid 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 bempedoic acid on cardiovascular morbidity and
mortality has not been determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
Hyperuricemia: Bempedoic acid 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
bempedoic acid at the first sign of tendon rupture. Avoid bempedoic
acid 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 bempedoic acid be taken during breastfeeding.
Discontinue bempedoic acid when pregnancy is recognized, unless the
benefits of therapy outweigh the potential risks to the fetus.
Based on the mechanism of action, bempedoic acid may cause fetal
harm.
Please see full Prescribing Information here.
Esperion TherapeuticsEsperion 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. For more information, please
visit www.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 relating to the expected closing of the exchange of the
Notes pursuant to the Exchange Agreement and expectations regarding
future transactions to further improve ESPERION’s balance sheet.
Such forward-looking statements involve risks and uncertainties
that could cause actual results to differ materially from predicted
or expected results. The inclusion of forward-looking statements
should not be regarded as a representation by ESPERION that any of
these results will be achieved. Actual results may differ from
those set forth in this Report due to the risks and uncertainties
associated with the satisfaction of closing conditions under the
Exchange Agreement and with entering into additional exchange
agreements, as well as risks and uncertainties described in
ESPERION’s filings with the U.S. Securities and Exchange
Commission. Any forward-looking statements contained in this Report
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. All forward-looking statements are
qualified in their entirety by this cautionary statement.
Contact:Corporate
Communicationscorporateteam@esperion.com
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