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
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.”
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.
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
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
Incyte to Present Multiple Studies from Dermatology Portfolio at 2023 European Academy of Dermatology and Venereology (EADV) Congress29.9.2023 20:43:00 EEST | Press release
Incyte (Nasdaq:INCY) today announced multiple abstracts featuring new data from across its dermatology portfolio have been accepted for presentation at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 held October 11-14 in Berlin. “We are pleased to add to the data supporting the use of ruxolitinib cream for patients living with vitiligo and atopic dermatitis (AD) through two late-breaking presentations – one on prolonged use of treatment in vitiligo patients with limited or no initial response, and the full results of our TRuE-AD3 trial in pediatric AD,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “Collectively, the data at this year's Congress, which also include new late-breaking data for povorcitinib in vitiligo, emphasize our ongoing efforts to advance treatment options for the Dermatology community." Key abstracts from Incyte-sponsored programs include: Late-breaking Oral Presentations Vitiligo Efficacy an
Q4 Inc. Recognized as one of Canada’s Top Growing Companies by The Globe and Mail29.9.2023 17:30:00 EEST | Press release
Q4 Inc. (TSX: QFOR) (“Q4” or “the Company”), the leading capital markets access platform, is pleased to announce their ranking on the 2023 Report on Business of Canada’s Top Growing Companies. Canada’s Top Growing Companies ranks Canadian companies on three-year revenue growth. Q4 earned its spot with three-year growth of 150%. “We are honored to be recognized as one of Canada’s Top Growing Companies for the fourth consecutive year by The Globe and Mail,” remarked Darrell Heaps, Founder and CEO of Q4. “We are proud of the growth we have achieved as a company and this recognition is a true reflection of our dedication to helping our clients win in the capital markets through innovative technology on the Q4 Platform.” Canada’s Top Growing Companies is an editorial ranking that was launched in 2019. It aims to bring the accomplishments of innovative businesses in Canada to the forefront. In order to qualify for this voluntary program; companies had to complete an in-depth application proc
GEDi Cube and Renovaro Biosciences Sign Definitive Agreement to Combine29.9.2023 16:15:00 EEST | Press release
GEDi Cube Intl Ltd. (GEDi Cube), an AI medical technology company, and Renovaro Biosciences Inc. (NASDAQ:RENB) (Renovaro), an advanced, preclinical biotechnology firm in cell, gene and immunotherapy, have signed a definitive agreement to combine, in which GEDi Cube will become a wholly-owned subsidiary of Renovaro in a stock-for-stock acquisition (the “Transaction”). If completed, the Transaction will result in a combined company that will offer advanced early diagnosis and early identification of recurring cancer as well as potential therapies for several critical diseases such as pancreatic cancer and other solid tumors with poor life expectancy. The combined company will have a unique advantage: Renovaro Biosciences’ pre-clinical and clinical trial data could be utilized to accelerate GEDi Cube’s AI capabilities that, in turn, could potentially help to accelerate Renovaro’s development of potential new therapies. AI will be used to advance the fields of diagnosis and treatment with
Offshore Windfarm Hollandse Kust Zuid Inaugurated29.9.2023 14:53:00 EEST | Press release
Today, Dutch King Willem-Alexander jointly with the board members of Vattenfall, BASF, and Allianz officially inaugurated the offshore wind farm Hollandse Kust Zuid 1-4. The wind farm is in the North Sea, 18-36 kilometers off the Dutch coast between the towns of Scheveningen and Zandvoort. The 139 turbines have a total capacity of 1.5 GW, making it one of the largest offshore wind farms in the world. The annual electricity production is expected to equal the consumption of 1.5 million households. Hollandse Kust Zuid is owned by Vattenfall, BASF, and Allianz. The wind farm is expected to be fully operational in 2024 and will be serviced out of the port of IJmuiden. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230929518869/en/ Inauguration Hollandse Kust Zuid wind farm. From left to right: Helene Biström (Senior Vice President, Head of Business Area Wind Vattenfall), Martijn Hagens (CEO Vattenfall Netherlands), His Majesty K
The Estée Lauder Companies Launches 2023 Breast Cancer Campaign: Beautifully United to Help End Breast Cancer29.9.2023 14:00:00 EEST | Press release
For more than 30 years, The Estée Lauder Companies’ Breast Cancer Campaign (The Campaign) has been dedicated to advancing the possibility of a breast cancer-free world for all. This October, The Estée Lauder Companies (ELC) honors Breast Cancer Awareness Month by launching The Campaign in support of the global breast cancer community. As ELC’s largest corporate social impact program, The Campaign continues to inspire purpose-driven action and is a cornerstone of the company’s social investments in women’s advancement, health and education. Through The Campaign, ELC has also been a longstanding supporter of women in science, research and medicine – funding numerous grants and programs around the world and accelerating opportunities for women in STEM. The Campaign was founded by Evelyn H. Lauder in 1992 with the launch of the iconic Pink Ribbon. At a time when breast cancer wasn’t spoken about openly, Evelyn and ELC saw an opportunity to bring awareness to the disease and address stigmas
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