Pravastatin

Esperion Presents Two CLEAR Outcomes Study Late-Breakers at European Society of Cardiology Congress 2023

Retrieved on: 
Saturday, August 26, 2023
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ANN ARBOR, Mich., Aug. 26, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of results from two oral presentations at the Late-Breaking Science Session entitled, “Clinical trial updates on prevention and lipid lowering” at the European Society of Cardiology (ESC) 2023 Congress, taking place August 25-28, 2023, in Amsterdam, Netherlands.

Key Points: 
  • “We are pleased to share additional results from our landmark CLEAR Outcomes study in late-breaker presentations at ESC 2023,” said Sheldon Koenig, President and CEO of Esperion.
  • Of the 13,970 patients included in CLEAR Outcomes, 45.6% had diabetes, 41.5% were pre-diabetic, and 12.9% had normoglycemia.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Esperion Presents Results from New Analysis on Cardiovascular Benefits with Bempedoic Acid Treatment at ENDO 2023

Retrieved on: 
Thursday, June 15, 2023
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“We are pleased to present this analysis at ENDO 2023, demonstrating that the cardiovascular risk reduction benefit of bempedoic acid treatment is comparable to that of statins based on an analysis of per unit decrease in LDL-C,” said Sheldon Koenig, President and CEO of Esperion.

Key Points: 
  • “We are pleased to present this analysis at ENDO 2023, demonstrating that the cardiovascular risk reduction benefit of bempedoic acid treatment is comparable to that of statins based on an analysis of per unit decrease in LDL-C,” said Sheldon Koenig, President and CEO of Esperion.
  • The beneficial effect of bempedoic acid on MVE reduction generally improved over time, similar to what was observed in statin CVOTs.
  • Limitations of Use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Esperion Retains Gibson Dunn to Secure $300 Million Payment From DSE; Will Announce First Quarter Financial Results Tuesday, May 9

Retrieved on: 
Thursday, May 4, 2023
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The complaint seeks a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300 million milestone payment to Esperion upon regulatory approval.

Key Points: 
  • The complaint seeks a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300 million milestone payment to Esperion upon regulatory approval.
  • “This amended complaint, filed by Gibson Dunn and supported by new evidence, makes clear that we are entitled to the $300 million milestone payment from DSE upon regulatory approval.
  • We will not acquiesce to DSE’s commercially dishonest tactics,” says Esperion President and Chief Executive Officer Sheldon Koenig.
  • “We are working diligently to resolve this dispute as we continue to commercialize bempedoic acid in Europe and around the world.

Esperion Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, February 21, 2023
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ANN ARBOR, Mich., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

Key Points: 
  • “I’m proud of the entire organization at Esperion and our ability to deliver on the commitments we made in 2022.
  • The increase for the fourth quarter ended December 31, 2022, is related to increases in net U.S. product revenue and royalty revenue.
  • These decreases reflect savings from the transformative plan implemented in the fourth quarter of 2021.
  • Esperion works hard to make our medicines easy to get, easy to take, and easy to have.

Esperion Announces Positive CLEAR Outcomes Results To Be Presented as Late-Breaking Clinical Trial at ACC.23/WCC

Retrieved on: 
Monday, February 20, 2023
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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.

Key Points: 
  • 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.
  • Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
  • Drug Interactions: Simvastatin and Pravastatin: Concomitant use results in increased concentrations and increased risk of simvastatin or pravastatin-related myopathy.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.

New Data Links Modulation of Key Immune-Related Proteins to Improvement of Specific Symptoms in Long COVID

Retrieved on: 
Thursday, February 16, 2023
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Data from a new clinical study show modulation of key immune regulating proteins with maraviroc and pravastatin correlates with symptom reduction in patients with post-acute sequelae of COVID (PASC), commonly known as long COVID.

Key Points: 
  • Data from a new clinical study show modulation of key immune regulating proteins with maraviroc and pravastatin correlates with symptom reduction in patients with post-acute sequelae of COVID (PASC), commonly known as long COVID.
  • The study results, published in Frontiers in Medicine, also support a precision medicine approach to diagnosis of long COVID as well as differentiation of long COVID from ME-CFS (myalgic encephalomyelitis/chronic fatigue syndrome), which presents with similar symptoms.
  • Subjective neurological, autonomic, respiratory, cardiac and fatigue symptoms scores all decreased by statistically significant margins.
  • In particular, the FSS (fatigue being the most common symptom) decreased and was closely correlated in decreases of IL-2 and TNF-α.

Esperion Announces CLEAR Cardiovascular Outcomes Trial of NEXLETOL® (bempedoic acid) Meets Primary Endpoint

Retrieved on: 
Wednesday, December 7, 2022
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ANN ARBOR, Mich., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 in patients treated with 180 mg/day NEXLETOL compared to placebo.

Key Points: 
  • CLEAR Outcomes further strengthens the clinical evidence supporting the role of bempedoic acid for patients.”
    Cardiovascular disease remains the number one killer globallyi.
  • A large proportion of patients at risk for cardiovascular events based on elevated LDL-cholesterol and apolipoprotein b are not adequately treated with existing therapies.
  • Despite recent therapeutic advances, there remains a significant need for new treatment options to help improve long-term cardiovascular outcomesii.
  • Limitations of Use: The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

Esperion Announces Five Abstracts Accepted for Presentation at the National Lipid Association Scientific Sessions

Retrieved on: 
Tuesday, May 31, 2022
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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.

Key Points: 
  • Limitations of Use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined.
  • 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.
  • Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
  • Esperion works hard to make our medicines easy to get, easy to take and easy to have.

Esperion Announces Publication of CLEAR Harmony Open-Label Extension Study Data for Bempedoic Acid in the American Journal of Cardiology

Retrieved on: 
Monday, May 2, 2022
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ANN ARBOR, Mich., May 02, 2022 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the publication of data from the CLEAR Harmony Open-Label Extension (OLE) Study of bempedoic acid, also known as NEXLETOL, in the American Journal of Cardiology.

Key Points: 
  • ANN ARBOR, Mich., May 02, 2022 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the publication of data from the CLEAR Harmony Open-Label Extension (OLE) Study of bempedoic acid, also known as NEXLETOL, in the American Journal of Cardiology.
  • The paper, Long-term Safety and Efficacy of Bempedoic Acid in Patients with Atherosclerotic Cardiovascular Disease and/or Heterozygous Familial Hypercholesterolemia (From the CLEAR Harmony Open-Label Extension Study), described the results from the 78-week, Phase 3, OLE study that followed the 52-week CLEAR Harmony Phase 3 study.
  • In the CLEAR Harmony study, patients were randomized 2:1 to bempedoic acid or placebo for 52 weeks.
  • Importantly, the safety profile of bempedoic acid in the OLE study was comparable to findings from the parent study and no new safety concerns were observed.

Esperion to Present Key Science at the American Heart Association Scientific Sessions 2021

Retrieved on: 
Monday, November 1, 2021
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Limitations of Use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined.

Key Points: 
  • Limitations of Use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined.
  • 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.
  • The inclusion of forward-looking statements should not be regarded as a representation by ESPERION that any of these results will be achieved.