-
Esperion Announces Five Abstracts Accepted for Presentation at the National Lipid Association Scientific Sessions
Источник: Nasdaq GlobeNewswire / 31 май 2022 08:00:01 America/New_York
– Highlight of accepted abstracts includes new real-world data on lipid-lowering therapy usage, submitted in partnership with UT Southwestern –
– Accepted abstracts showcase breadth of Esperion’s research into efficacy of bempedoic acid in patients with atherosclerotic cardiovascular disease and a variety of comorbid metabolic conditions –
ANN ARBOR, Mich., May 31, 2022 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced five abstracts have been accepted for presentation at the National Lipid Association Scientific Sessions (NLA 2022 Scientific Sessions) being held in-person in Scottsdale, Arizona.
“In the wake of the pandemic, the US is in serious risk of moving backward on critical public health initiatives like maintaining a healthy cholesterol and metabolic profile. We believe Esperion is uniquely positioned to help address this issue with our approved therapies,” said Sheldon Koenig, president and chief executive officer of Esperion. “That is one reason we are presenting our real-world analysis on the major gaps in cardiovascular and metabolic care in advance of readouts from our upcoming pivotal CLEAR Outcomes study.”
Expert Theatre
Title: Add on Efficacy. Oral, Nonstatin Therapies for Lowering LDL-C Date & Time: 6/4/2022, 8:00 – 8:50 AM Speaker: William Cromwell, MD, FAHA, FNLA E-Poster Presentations
Title: Safety and efficacy of bempedoic acid in patients with renal impairment* Abstract #: 32 Date & Time: 6/3/2022, 11:25-11:42 AM Authors: Presented on behalf of all authors by Peter Toth, MD, PhD, FCCP, FAHA, FESC, FACC Title: Efficacy and safety of bempedoic acid in patients with metabolic syndrome* Abstract #: 34 Date & Time: 6/3/2022, 11:48 AM-12:05 PM Authors: Presented on behalf of all authors by Michael Shapiro, DO, MCR, FACC, FNLA Title: Pharmacokinetics, pharmacodynamics, and safety of bempedoic acid in a Phase 1 clinical trial in healthy Japanese, Chinese and White subjects* Abstract #: 35 Date & Time: 6/3/2022, 11:48 AM-12:05 PM Authors: Presented on behalf of all authors by Benny Amore, PhD Title: Lipid-Lowering Therapy for Primary Prevention of Cardiovascular Disease: A Nationwide Analysis of 440,721 Patients Abstract #: 73 Date & Time: 6/3/2022, 11:48 AM-12:05 PM Authors: Presented on behalf of all authors by Ahmed Kolkailah, MD, MSc Title: Safety and efficacy of bempedoic acid in patients with hypertension* Abstract #: 33 Date & Time: 6/3/2022, 11:00-11:17 AM Authors: Presented on behalf of all authors by Keith Ferdinand, MD, FACC, FAHA, FASH, FNLA *Encore presentations
INDICATION
Bempedoic 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 for bempedoic acid by clicking here.
Esperion Therapeutics
Esperion 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. Esperion commercializes NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Tablets and is the leader in the development of convenient oral, once-daily non-statin LDL-cholesterol lowering drugs for patients with high levels of bad cholesterol. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.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 commercial products, 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:
Corporate Communications
corporateteam@esperion.com