The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat.

Start Date01 Mar 2024

Sponsor / Collaborator

University of Louisville

NCT05798390 / WithdrawnNot Applicable

Non-Interventional Study On The Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia

Cardiovascular disease (CVD), especially its management and associated costs, remains a major concern globally. There is a direct correlation between circulating levels of low-density lipoprotein cholesterol (LDL-C) and the incidence of CVD.
This study will assess bempedoic acid/FDC in a real-world clinical setting in adult patients in Spain with hypercholesterolaemia or mixed dyslipidemia.

Start Date01 Sep 2023

Sponsor / Collaborator

Daiichi Sankyo Europe GmbH

NCT06021951 / CompletedPhase 4

An Open-Label Postmarking Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid and Ezetimibe in the Breast Milk of Healthy Lactating Women Administered Therapeutic Doses of Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP)

This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily infant dosage and the relative infant dose (RID) of bempedoic acid or bempedoic acid and ezetimibe in breast milk after 6 consecutive daily doses of bempedoic acid or bempedoic acid/ezetimibe FCDP.

Start Date04 Aug 2023

Sponsor / Collaborator

Esperion Therapeutics, Inc.

100 Clinical Results associated with Bempedoic acid/Ezetimibe

100 Translational Medicine associated with Bempedoic acid/Ezetimibe

100 Patents (Medical) associated with Bempedoic acid/Ezetimibe

Literatures (Medical) associated with Bempedoic acid/Ezetimibe

01 Feb 2021·Clinical therapeuticsQ4 · MEDICINE

Bempedoic Acid: A New Tool in the Battle Against Hyperlipidemia

Q4 · MEDICINE

Review

Author: Powell, Jason ; Piszczatoski, Chris

PURPOSE:

This article discusses the pharmacology of bempedoic acid, the trials that led to United States Food and Drug Administration (FDA) approval of its use, and the overall safety and efficacy of this therapy in heterozygous familial hypercholesterolemia, established atherosclerotic cardiovascular disease (ASCVD), and hyperlipidemia.

METHODS:

A database search of PubMed and ClinicalTrials.gov was conducted for articles published between January 2012 to September 2020 and containing the key words bempedoic acid, ezetimibe, Nexletol and Nexlizet. Trials from the CLEAR series were selected, as they played a pivotal role in the establishment of FDA approval, along with additional trials published after FDA approval, which provided novel evidence on the use of bempedoic acid in the treatment of hypercholesterolemia. Publications that were not randomized, controlled trials were not included in this review. Only randomized controlled trials in which ezetimibe was used in conjunction with bempedoic acid were included in this review as they were relevant to the new FDA approval of bempedoic acid.

FINDINGS:

The findings of the present review show that bempedoic acid is both an effective and well-tolerated option for the treatment of hypercholesterolemia when used without ezetimibe in addition to standard therapy. It also appears that the combination with ezetimibe increases the cholesterol-lowering effect more than either agent alone when added to standard therapy.

IMPLICATIONS:

Hypercholesteremia continues to be a major contributing factor leading to ASCVD. Bempedoic acid is an additional treatment option, along with both statins and diet and exercise, for reducing cholesterol levels and ASCVD events. With the new FDA approval, bempedoic acid may offer an effective therapy for reducing low-density lipoprotein cholesterol in patients at high risk for cardiovascular events due to established ASCVD or heterozygous familial hypercholesterolemia.

01 May 2020·DrugsQ1 · MEDICINE

Bempedoic Acid: First Approval

Q1 · MEDICINE

Review

Author: Markham, Anthony

Bempedoic acid is a non-statin antihyperlipidaemic drug being developed by Esperion Therapeutics for the treatment of hypercholesterolaemia. Based on positive findings in the phase III CLEAR clinical trial programme, bempedoic acid has been approved in the USA and in the EU as monotherapy (NEXLETOL^® in the USA, Nilemdo^® in the EU) and as a fixed-dose combination with ezetimibe (NEXLIZET^® in the USA, Nustendi^® in the EU). This article summarizes the milestones in the development of bempedoic acid leading to these first approvals.

News (Medical) associated with Bempedoic acid/Ezetimibe

27 Sep 2024

·www.businesswire.com

Final Real-World Results from MILOS German Cohort Demonstrate Strong Increase in LDL-C Goal Achievement With Addition of Bempedoic Acid

MUNICH--( BUSINESS WIRE )--For EU media only Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced final 2-year follow-up data from the German cohort of the multinational, European observational MILOS study. 1 The study evaluated the real-world use of bempedoic acid, marketed as NILEMDO ® ▼ and its FDC with ezetimibe, NUSTENDI ® ▼, in patients with primary hypercholesterolaemia or mixed dyslipidaemia. The results, presented in Hamburg, Germany at DGK Hertztage 2024, demonstrated the effectiveness and safety profile of bempedoic acid, both alone and in combination with other lipid-lowering therapies (LLTs) in clinical practice. 1 Raised LDL-C is a key modifiable contributor to risk of major cardiovascular events, with studies showing that every 1 mmol/L reduction in LDL-C is associated with a 22% reduction in major cardiovascular events after one year. 5,6 The German cohort of MILOS study comprising 973 patients from 125 sites in Germany, is one of the most comprehensive assessments of bempedoic acid in a real-world clinical setting to-date in Germany. 1 Patients were followed-up for two years, with LDL-C levels assessed at pre-treatment, one year (1Y) and two years (2Y). Overall, 638 of 973 patients (65.6%) completed 2Y follow up, with LDL-C values at pre-treatment, 1Y and 2Y available for 451 patients. In these 451 patients, a mean reduction of LDL-C levels from 3.1 mmol/L (121.4 mg/dL) at pre-treatment, to 2.0 mmol/L (77.2 mg/dL) was observed, representing an average relative reduction of 30.3% in the overall population. 1 Additionally, the percentage of patients reaching their LDL-C goals increased from 4.9% at pre-treatment to 35.3% at the 2Y follow-up – an approximately 7-fold increase. 1 The proportions of high-risk and very high-risk patients reaching LDL-C goals increased from 5.6% to 32.5%, and 3.6% to 35.2%, respectively. 1 Overall, more than 80% of patients received bempedoic acid in combination with other LLTs at pre-treatment and 2Y, including statins and ezetimibe. The safety profile of bempedoic acid in this real-world population was assessed at 1Y and 2Y and was consistent with that observed in the CLEAR clinical trial programme. 2,3,4 “By significantly lowering LDL-C levels toward guideline goals, we are taking a vital step in reducing the risk of cardiovascular events, which can have a profound impact on a person’s long-term health and quality of life,” said Professor Ioanna Gouni-Berthold, University of Cologne, Center for Endocrinology, Diabetes, and Preventive Medicine and Executive Board Member of the International Atherosclerosis Society . “Cardiovascular disease remains Europe’s leading cause of death, yet the majority of premature CV events are preventable,” 7,8 said Dr. Stefan Seyfried, Vice President Medical Affairs, Specialty Medicines, at Daiichi Sankyo Europe GmbH . “ The findings from this cohort reinforce the benefit provided by bempedoic acid for reducing LDL-C levels. Our long-term goal is to empower the medical community with real-world insights to improve CVD prevention and, ultimately, improve patient care.” -ENDS- About MILOS MILOS (NCT04579367) is an ongoing, multinational, European observational study in adult patients diagnosed with primary hypercholesterolaemia or mixed dyslipidaemia. The aim is to evaluate the real-world use of bempedoic acid and bempedoic plus ezetimibe FDC. Patients in the German cohort were recruited from 125 sites between January 2021 and January 2022 and were followed up for 2 years after baseline measurements. 1 Change in LDL-C levels and the proportion of patients achieving LDL-C goal were assessed in patients at pre-treatment, 1Y and 2Y visits. Analyses were stratified by investigator-assessed CV risk, based on the ESC/EAS dyslipidaemia guidelines. 1 Beyond Germany, MILOS has sites in Austria, Belgium, Italy, the Netherlands, Spain, Switzerland and the UK. 9 About Bempedoic Acid and its Fixed-Dose Combination with Ezetimibe Bempedoic acid (NILEMDO ® ) is a first-in-class, oral, once-daily treatment to lower cholesterol, and can be combined with other oral treatments to help lower cholesterol even further. 10 Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver. 10 Bempedoic acid acts on the well-known cholesterol synthesis pathway, upstream of the statin target in the liver, which allows additional LDL-C lowering when added to statin or other LDL-C-lowering therapies. 11 Bempedoic acid is not activated in skeletal muscle. 10 Bempedoic acid is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: 10 in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, 10 alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. 10 Bempedoic acid is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: 10 in patients on a maximum tolerated dose of statin with or without ezetimibe or, 10 alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin in contraindicated. 10 The bempedoic acid / ezetimibe FDC (NUSTENDI ® ) combines two complementary ways of reducing cholesterol in a once-daily tablet. Bempedoic acid / ezetimibe FDC is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: 12 in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe, 12 alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, 12 in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin. 12 Bempedoic acid / ezetimibe FDC is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: 12 in patients on a maximum tolerated dose of statin and not adequately controlled with additional ezetimibe treatment or, 12 in patients who are either statin-intolerant, or for whom a statin in contraindicated, and not adequately controlled with ezetimibe treatment or, 12 in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets. 12 Daiichi Sankyo Europe has licensed exclusive commercialisation rights to bempedoic acid and its FDC with ezetimibe (marketed as NILEMDO ® and NUSTENDI ® ) in the European Economic Area, UK, Turkey and Switzerland from Esperion and is the full Marketing Authorisation Holder in these territories. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need. For more information, please visit https://www.daiichi-sankyo.eu/ ▼ This medicinal product is subject to additional monitoring. References 1 DGK Hertztage 2024 Abstract. Real-world effectiveness and safety of bempedoic acid in Europe: final 2-year results from the MILOS German cohort. Gouni-Berthold, I et al. 2 Nissen SE, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med . 2023;388:1353–64 3 Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med . 2019; 380:1022–32 4 Ballantyne CM, et al . Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol . 2020; 27(6): 593–603 5 Cholesterol Treatment Trialists’ (CTT) Collaboration. 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. 376(9753): 1670–1681 6 NHS England. Improving lipid management to reduce cardiovascular disease and save lives. Available at: https://www.england.nhs.uk/long-read/improving-lipid-management-to-reduce-cardiovascular-disease-and-save-lives/#:~:text=Raised%20LDL%20cholesterol%20is%20one,vascular%20events%20after%201%20year . Last accessed September 2024. 7 Eurostat. (2023) Causes of death statistics. Available at: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Causes_of_death_statistics#Major_causes_of_death_in_the_EU_in_2020 . Last accessed September 2024. 8 World Heart Federation. Prevention. Available at: https://world-heart-federation.org/what-we-do/prevention/#:~:text=An%20estimated%2080%25%20of%20cardiovascular,and%20“knowing%20your%20numbers ”. Last accessed September 2024 9 ClinicalTrials.gov. Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS). Available at: https://clinicaltrials.gov/study/NCT04579367#contacts-and-locations . Last accessed September 2024. 10 European Medicines Agency. Nilemdo – Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf . Last accessed September 2024. 11 Pinkosky, S.L., et al . Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun . 2016. 7: 13457. 12 European Medicines Agency. Nustendi –Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf . Last accessed September 2024 HQ/BIL/09/24/0001

Drug ApprovalClinical ResultAHAClinical StudyLicense out/in

03 Sep 2024

·www.fiercepharma.com

Daiichi study finds gender inequality in European cardiovascular care

Daiichi Sankyo sells Esperion Therapeutics’ lipid-lowering drugs Nilemdo and Nustendi in Europe. Daiichi Sankyo has identified inequalities in cardiovascular disease treatment and outcomes, finding that women in Europe are less likely than men to receive lipid-lowering therapies and achieve LDL cholesterol goals.The findings come from a subanalysis of SANTORINI, an observational study Daiichi funded to shed light on the care of people with high and very high cardiovascular risk in Europe. Investigators looked at how physicians assess risk and approach lipid-lowering regimens as well as the extent to which their decisions would enable the attainment of lipid goals set by cardiology groups.Daiichi used the European Society of Cardiology Congress in London to share more data from the SANTORINI study. The subanalysis looked at 5,197 men and 2,013 women with similar mean ages, 65 years and 66 years, respectively. Daiichi said guideline recommendations for the men and women are similar.At baseline, physicians opted against prescribing a lipid-lowering therapy to 23.9% of women, compared to 20.7% of men. Most of the untreated women had received a lipid-lowering drug one year later, but the gap with men persisted. The proportion of women not on lipid-lowering therapy after one year was 3.9%. The figure for men was 2.7%. Women were less likely to achieve cholesterol targets. The proportion of patients reaching LDL-C goals improved from baseline to one-year follow-up in both cohorts but was greater in men, 22.9% and 33.3%, respectively, than in women. The figures for women were 16.9% and 24.6%.“This new sub-analysis of the SANTORINI study further suggests that in clinical practice, women as a group were being disproportionally undertreated and do not always reach recommended LDL-C level goals,” the University of Lausanne’s David Nanchen, M.D., said in a statement. “These findings underscore the need for more widespread attention to better manage the risk of cardiovascular disease in women.”Daiichi, which sells Esperion Therapeutics’ lipid-lowering drugs Nilemdo and Nustendi in Europe, said its commitment to addressing key unmet needs and barriers in cardiovascular care is reinforced after seeing the data. Nilemdo and Nustendi were approved to reduce the risk of adverse cardiovascular events in Europe in May. Daiichi named the drugs as growth drivers at its EU specialty unit in its first quarter.

Drug ApprovalAHA

25 Mar 2024

·endpts.com

Esperion eyes new commercial push for cholesterol-lowering drugs after big FDA label expansion

Esperion has secured major FDA label expansions for its two cholesterol-lowering drugs, a regulatory milestone that it says opens up a much bigger market and “significantly reduces previously existing prescribing limitations.” Nexletol and Nexlizet are now approved to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use. Both pills contain bempedoic acid, Esperion’s key asset, with one being a monotherapy and the other being a combination with another cholesterol-lowering drug, ezetimibe. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Drug Approval

100 Deals associated with Bempedoic acid/Ezetimibe

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C10BA	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Cardiovascular Diseases	US	Esperion Therapeutics, Inc.	22 Mar 2024
Myocardial Infarction	US	Esperion Therapeutics, Inc.	22 Mar 2024
Primary Hyperlipidemia	US	Esperion Therapeutics, Inc.	22 Mar 2024
Dyslipidemias	EU	Daiichi Sankyo Europe GmbH	27 Mar 2020
Dyslipidemias	IS	Daiichi Sankyo Europe GmbH	27 Mar 2020
Dyslipidemias	LI	Daiichi Sankyo Europe GmbH	27 Mar 2020
Dyslipidemias	NO	Daiichi Sankyo Europe GmbH	27 Mar 2020
Primary hypercholesterolemia	EU	Daiichi Sankyo Europe GmbH	27 Mar 2020
Primary hypercholesterolemia	IS	Daiichi Sankyo Europe GmbH	27 Mar 2020
Primary hypercholesterolemia	LI	Daiichi Sankyo Europe GmbH	27 Mar 2020
Primary hypercholesterolemia	NO	Daiichi Sankyo Europe GmbH	27 Mar 2020
Atherosclerosis	US	Esperion Therapeutics, Inc.	26 Feb 2020
Heterozygous familial hypercholesterolemia	US	Esperion Therapeutics, Inc.	26 Feb 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03531905 (CTgov)	Phase 2	Hyper LDL cholesterolaemia \| Diabetes Mellitus, Type 2	242	Placebo Oral Tablet+Ezetimibe 10 mg Oral Tablet (Ezetimibe 10 mg)	fravoiglyp(dtoxjflqjq) = btgwremkle zzsgfmiace (lgafqdlubz, iztgmdyakp - jcklexmltv) View more	-	09 Apr 2020
				Placebo oral capsule (Placebo)	fravoiglyp(dtoxjflqjq) = yptdfcardi zzsgfmiace (lgafqdlubz, tekuzjqmtv - giggrlesmb) View more

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