Business Wire

Latest simulation analyses from the SANTORINI registry indicates that adding bempedoic acid in the lipid lowering treatment algorithm might help more patients achieve LDL-C recommended goals

Share

Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) announced today new data presented at the European Society of Cardiology Congress 2022 from its multinational prospective, observational study, SANTORINI across 14 countries.5 New simulation data adds to the growing body of evidence that indicates that maximising oral combination therapies by using ezetimibe and bempedoic acid after statins, might result in significantly more patients attaining European-guideline recommended LDL- goals and thereby potentially reducing their risk of cardiovascular events.2,4,6

Simulation of LCL-C risk reduction

Through simulation, researchers investigated the addition of bempedoic acid to ezetimibe in the treatment pathway for patients at high- and very high-risk of cardiovascular events due to hypercholesterolaemia using the SANTORINI data, to assess the proportion of patients who might reach their European-guideline recommended lipid goals. The data presented today indicate that of those patients on ezetimibe and not currently at goal, the addition of bempedoic acid is projected to result in another 36% (n=1222/3412) goal achievement.2

The analysis included a cohort of 6177 patients who were receiving any known LLT regimen with LDL-C data and known CV risk status at the SANTORINI baseline.2 A treatment algorithm was applied to those not at their risk-based LDL-C goals at baseline by first adding ezetimibe if not already and subsequently bempedoic acid if they were not at goal.2 Patients on PCSK9i inhibitors were not used in the simulation steps irrespective of goal achievement.2 The effect of treatment on LDL-C levels was simulated through a Monte Carlo simulation run 10,000 times.2 LDL-C reductions associated with ezetimibe and bempedoic acid treatment were based on probabilistic distributions sourced from clinical trial efficacies based on published studies.2

Overall, the number of patients at the European guideline recommended goal would be expected to increase from 1,428 (23.1%) at baseline to 2,455 (39.7%) and 3,677 (59.5%) after addition of ezetimibe and bempedoic acid, sequentially.2 Furthermore, the mean LDL-C for the whole cohort would be expected to fall through this pathway from 80.33 mg/dL at baseline to 69.28 mg/dL and 60.94 mg/dL, respectively.2

The 2019 ESC/EAS management of dyslipidaemia guidelines recommend that the LDL-C goals for treating patients at high- and very high-risk of CV events are <1.8 mmol/L and <1.4 mmol/L, respectively.4 However, previous research from the SANTORINI registry show that only 20.1% of patients had achieved their risk-based LDL-C goal, with mean LDL-C levels reported in the clinical setting as 2.41 mmol/L - much higher than European guideline recommendations.3,4 For those patients who remain at high residual risk of CV events due to elevated LDL-C levels, the guidelines recommend more intense treatment, including use of combination therapy.4

The simulation data presented today adds to the growing body of evidence that optimising use of bempedoic acid in addition to ezetimibe could result in significantly more patients attaining recommended lipid goals and thereby reducing their risk of atherosclerotic cardiovascular disease.2

“This is the first simulation data from the SANTORINI registry that allows us to assess the proportion of patients who might reach LDL-C goal with the addition of bempedoic acid to existing treatment algorithms, said Professor Kausik Ray, Professor of Public Health and President of the European Atherosclerosis Society, Honorary Consultant Cardiologist, Director ICTU Global and Deputy Director of the Imperial Clinical Trials Unit at Imperial College London, and Principal Investigator of SANTORINI. “We know that many at-risk patients are still not achieving their recommended goals, and today’s data reinforces recommendations from guidelines that we must intensify treatment for those at the highest levels of risk for heart attacks and strokes. The simulation data provides a positive indication of how we can better help our patients to achieve their LDL-C goals in clinical practice and ultimately improve their outcomes.

CV risk factors in patients with and without a history of atherosclerotic cardiovascular disease (ASCVD)

In another sub-analysis from the SANTORINI registry of 9,044 patients, those patients whose CV risk was classified by the investigator based on the 2019 ESC/EAS guidelines was re-assessed centrally based on the data present in the study database.1 Overall, ESC/EAS guidelines were most commonly used basis for risk classification (52.0%).1,4 Among all patients, the investigator assessed 26.0% and 84.2% of patients without and with atherosclerotic CVD (ASCVD), respectively, as being very high-risk.1 In contrast, central re-estimation for those using ESC/EAS guidelines suggested that 54.7% and 100% of those without and with ASCVD were at very high-risk.1,4

CV risk factors or ASCVD were common in the SANTORINI study patients.1 Hypertension was the most common risk factor in both those with and without ASCVD, whereas diabetes and familial hypercholesterolaemia were most prevalent in patients without versus those with ASCVD (44.6% vs 30.3% and 18.6% vs 7.2%, respectively).1 Managing ASCVD is related to individual risk factors; the higher the risk the more intense the intervention required.4 Therefore, it is crucial to accurately identify the level of risk to ensure a tailored solution for ASCVD prevention and reduce the impact among patients.

“SANTORINI data presented during the ESC congress shows the CV risk of patients both with, and without, ASCVD is underestimated in clinical practice, potentially limiting the prevention of ASCVD across Europe.1” said Dr Stefan Seyfried, Vice President Medical Affairs Specialty Medicines, Daiichi Sankyo Europe GmbH, who added, “At Daiichi-Sankyo Europe, we understand the need to support and work with the clinical community to continue to embed the EAS/ESC guidelines into routine clinical practice. We are committed to working alongside clinicians to help reduce the number of lives that are affected by CVD every day by exploring the true impact of CVD in clinical care, through studies such as SANTORINI.”

-ENDS-

About SANTORINI:

The SANTORINI study is a multinational, prospective, observational study that enrolled 9,606 patients from over 800 sites in 14 countries across Europe. The primary objective is to document, in the real-world setting, the effectiveness of current treatment modalities in managing plasma levels of LDL-C in high- and very high-risk patients requiring lipid-lowering therapies. The study population consists of high- and very high-risk patients previously diagnosed and treated as well as newly diagnosed and requiring treatment.

Only data from routine clinical practice will be documented and physicians will not be required to perform any mandatory assessment outside the routine clinical practice. To facilitate accurate recording of data, patients can optionally fill in a memory aid to note important details. Completion of the SANTORINI study is anticipated in Q1 2023.

About bempedoic acid

Bempedoic acid (commercialised in the European Economic Area, Turkey and Switzerland as NILEMDO® 7) is a first-in-class, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further. Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.

Bempedoic acid has been approved for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • 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
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

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 lipid-lowering therapies. Due to its unique mechanism of action, bempedoic acid is not activated in skeletal muscle.

Daiichi Sankyo Europe has licensed exclusive commercialisation rights to bempedoic acid in the European Economic Area, Turkey and Switzerland from Esperion and is the full Marketing Authorisation Holder in these territories.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.”

For more information, please visit www.daiichisankyo.com

This medicinal product is subject to additional monitoring.

References

1 Ray, KK., et al. Cardiovascular risk factors in patients with and without a history of atherosclerotic cardiovascular disease in the SANTORINI study and estimation of risk. ePoster at the European Society of Cardiology 2022. Poster- 82567
2 Ray, KK., et al. Simulation of bempedoic acid in the lipid-lowering treatment pathway using the European contemporary SANTORINI cohort of high- and very high-risk patients. ePoster at European Society of Cardiology 2022 Abstract- 83386
3 Ray, KK, et al. Cardiovascular risk assessment by physicians and lipid-lowering therapy prescribing in high- and very high-risk patients: results from the multinational observational SANTORINI study. Poster 335 presented at the European Atherosclerosis Society (EAS) 2022.
4 Mach, F., et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk: The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J. 2019. 00: 1–78.
5 ClinicalTrials.gov. Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events (SANTORINI). Available at: https://clinicaltrials.gov/ct2/show/NCT04271280. Last accessed August 2022.
6 Blaum, C., et al. Target Populations and Treatment Cost for Bempedoic Acid and PCSK9 Inhibitors: A Simulation Study in a Contemporary CAD Cohort. Clinical Therapeutics. 2021: 43:9 1583-1600.
7 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 August 2022

CVD/22/0285
August 2022

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media contact
Dr. Wolfgang Schiessl
Daiichi Sankyo Europe GmbH
PR & Portfolio Communication Lead, Specialty Medicines
+49 151 1714 7317

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

AUTEL Launches Energy Storage Solutions7.10.2022 21:19:00 EEST | Press release

AUTEL (AUTEL EUROPE GmbH) launched its new energy storage solutions at eMove360° Europe 2022, for energy storage systems, commercial and industrial applications, and residential uses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221007005488/en/ The smartest hub to direct your home energy: Autel Hybrid Inverter (Photo: Business Wire) "With over 10 years of R&D experience, Autel continues to deliver industry breakthroughs in core technologies such as power electronics," said Mr. Ting Cai, CEO of Autel Europe GmbH. Autel offers optimal Levelized Cost of Electricity (LCOE) with improved safety achieved through continuous innovation in string design to address key industry challenges. The energy storage range includes the Autel Hybrid Inverter and the Autel ESS All-in-one. Autel Energy Storage Solutions address capacity limitations AUTEL believes that its energy storage products are capable of solving the problems of limited c

Acathia Capital Completes Acquisition of Swedish Life Insurer Futur Pension7.10.2022 12:51:00 EEST | Press release

With the receipt of approvals from the Swedish Financial Supervisory Authority, Acathia Capital has completed the increase of its stake in Futur Pension Försäkrings AB, the most successful life insurer in Sweden. Since 2019, Acathia Capital has been the joint lead investor, together with the Nordic private equity manager Polaris, in this investment, within a group of 5 institutional investors. As a result of the transaction, investment vehicles advised by Acathia have increased their joint stake in Futur Pension from 30% to almost 50%. Futur Pension is a powerful demonstration of how digitalization is fundamentally transforming the insurance business. The fintech, founded in 2000, has already fundamentally transformed the Swedish life insurance market in terms of cost and market share structure. Dr. Thomas Schmitt, managing partner of Acathia Capital, comments: “Futur Pension has increased its market share from 7% to over 11% of premium volume since we have become owners in 2019, makin

EIG’s MidOcean Energy to Acquire Tokyo Gas’ Interests in Portfolio of Four Australian Integrated LNG Projects for US$2.15 Billion7.10.2022 11:44:00 EEST | Press release

MidOcean Energy (“MidOcean”), an LNG company formed and managed by EIG, a leading institutional investor in the global energy and infrastructure sectors, today announced that it has entered into a definitive agreement with Tokyo Gas Co., Ltd (“Tokyo Gas”) to acquire Tokyo Gas’ interests in a portfolio of four Australian integrated LNG projects. Under the terms of the agreement, MidOcean will acquire Tokyo Gas’ interests in Gorgon LNG, Ichthys LNG, Pluto LNG and Queensland Curtis LNG for total cash consideration of US$2.15 billion. These integrated projects span Australia’s western and eastern seaboard and are major suppliers of LNG to Asia, with a diverse set of long-dated take or pay contracts with investment grade counterparties, and to Australia’s domestic gas markets. The portfolio is expected to generate approximately 1 million tonnes per annum of LNG net to MidOcean, production that is underpinned by long-life reserves and a globally competitive cost structure. The portfolio bene

Slate Asset Management Provides Fleet Financing to Move About Group AB to Support Rollout of Electric Vehicles and Charging Infrastructure Across Europe7.10.2022 10:00:00 EEST | Press release

Slate Asset Management (“Slate”), a global alternative investment platform targeting real assets, today announced that it has agreed to provide financing to Move About Group AB (“Move About”), a Swedish electric mobility service, to support the roll out of more than 150 electric vehicles and electric vehicle charging infrastructure throughout Europe. The car funding provided by Slate will be used to bolster Move About’s electric car fleet, which currently owns and operates over 800 electric cars and has more than 71,000 users on its platform. Move About is a Sweden-based electric mobility service that delivers environmentally friendly and cost-effective mobility solutions to over 300 locations across Sweden, Norway, and Germany. Move About has partnered with some of the largest companies across Europe to save tons of carbon dioxide emissions every year. Since it was founded in 2007, Move About has become the largest provider of emission-free carsharing in the Nordic region. Christian S

LabGenius Secures Government Innovation Grant to Expand ML-driven Drug Discovery Platform, EVA™7.10.2022 10:00:00 EEST | Press release

LabGenius, a pioneer in the use of machine learning (ML) for antibody engineering, today announced that it has been awarded a highly competitive SMART grant from Innovate UK. Grants from the £25 million fund allow businesses like LabGenius to realize the potential of new ideas by investing in game-changing, commercially viable research and development projects. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221007005023/en/ To date, LabGenius’ EVA platform has been used to co-optimize mono- and multi-specific single domain antibodies for biochemical and bio functional properties, including stability, potency and selective tumor cell killing. This grant will be used to further expand EVA 's capabilities by accelerating the platform’s ability to optimize antibody-based immune cell engager molecules. Many existing antibody therapeutics have poor selective cell killing profiles, which can result in on-target, off-tumor effects,

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom