Daiichi Sankyo Europe highlights need to address the perception and classification of CVD risk with data presentations at EAS 2022

• Latest data from the SANTORINI disease registry show that the cardiovascular (CV) risk of hypercholesterolaemia patients was underestimated considerably in the clinical setting.^1,2,3
• SANTORINI data show that nearly 80% of patients who are at high-risk or very high-risk of CV events do not attain guideline recommended low-density lipoprotein cholesterol (LDL-C) goals.^1,2,3
• Study data further demonstrates sub-optimal utilisation of lipid-lowering therapies (LLTs), resulting in a substantial proportion of patients remaining at high residual risk of CV events.^1,2

MUNICH–(BUSINESS WIRE)–Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) announced today multiple data presentations at the European Atherosclerosis Society (EAS) Congress 2022, highlighting the need to address current clinical perceptions and classification of risk of developing or exacerbating cardiovascular disease (CVD).^1,2 Latest data from SANTORINI, a multinational, prospective, observational study designed to assess the management of high- and very high-risk CV patients requiring lipid-lowering therapy (LLT) in routine clinical practice, demonstrated that the CV risk of patients analysed was notably underestimated in clinical practice according to European guidelines.^1,2,3

Data show that of the 9,044 patients analysed within the SANTORINI study 70.8% of patients were classified by the investigators as being at very high-risk and 29.2% as high-risk of heart attack or stroke. However, of those high-risk patients, 41.5% demonstrated evidence of atherosclerotic cardiovascular disease (ASCVD) which dictates a very high-risk classification per the EAS/ESC guidelines. This substantial underestimation of risk highlights a need for more stringent classification of patients against current European guidelines.^1,2,3

CV risk assessment is a determining criteria to inform treatment goals for patients with hypercholesteremia.³ Studies have shown a clear, causal effect of LDL-C in the development of ASCVD and, as such, European guidelines recommend use of lipid lowering therapies (LLTs) to reduce overall CV risk in high- and very high-risk patients.³

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.³ Baseline results of the SANTORINI registry presented today 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.^1,2 These findings complement data which were presented at the European Society of Cardiology (ESC) Congress in 2021, and further demonstrate the urgent need to reduce LDL-C levels for the 80% of patients that are not currently at target.^1,2,4

Despite LDL-C levels being above the recommended values for the majority of patients defined as being at high, or very high-risk of CV events, SANTORINI data show that 54.2% of patients are being treated with monotherapy, and 21.8% reported no use of LLT at all.^1,2 European guidelines recommend that the higher a patient’s risk, the more intense therapeutic intervention should be, suggesting that more emphasis needs to be placed on the optimisation of treatment, including combination therapy, for those patients who currently remain at high residual risk of CV events due to their elevated LDL-C.^1,2,3

“Today’s findings from the SANTORINI study clearly show that as clinicians, we must collectively review and update our perception of risk and associated risk factors when managing cholesterol levels for high- and very high-risk CVD patients. These results underscore a critical discrepancy between guideline recommendations and real-world practice” explained 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. “The vast number of patients who are still not reaching their LDL-C goals, as revealed through the SANTORINI study, highlights that risk classification must be a priority for the clinical community. The EAS/ESC guidelines underscore the need to optimise treatment to achieve LDL-C goals, including making better use of combination therapies, to reduce the risk of atherosclerotic cardiovascular disease and fatalities.”

Dr Garth Virgin, Executive Director Medical Affairs, Specialty Medicines, at Daiichi Sankyo Europe said, “With only 20% of patients reaching their LDL-C goals, it is critical that the pharmaceutical industry continues to support the clinical community to bring the EAS/ESC guidelines into their routine clinical practice and by doing so, help reduce the number of preventable cardiovascular events.” Dr Virgin continues, “there has been substantial progress in the prevention and treatment of cardiovascular disease over recent decades. However, today’s findings from the SANTORINI study highlight the need for greater understanding and collaboration to bring scientific information to the medical community and, ultimately, help to improve patient care.”

-ENDS-

About SANTORINI:

The SANTORINI study is a multinational, prospective, observational study that, to date, has enrolled more than 9,500 patients from over 800 sites in 14 countries across Europe.¹ 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.⁵ The study population consists of high- and very high-risk patients previously diagnosed and treated as well as newly diagnosed and requiring treatment.⁵ Initial data on SANTORINI were presented at ESC Congress 2021, organised by the European Society of Cardiology.⁴

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

References

¹ Ray KK, et al. Baseline characteristics and management of high- and very high-risk patients with hypercholesterolemia or mixed dyslipidemia in the multinational observational SANTORINI study. Poster presentation at the European Atherosclerosis Society (EAS) Congress 2022. Poster ID 433.

² 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 presentation at the European Atherosclerosis Society (EAS) Congress 2022. Poster ID 1573.

³ The Task Force for the management of dyslipidemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). ESC/EAS guidelines for the management of dyslipidemia. Eur Heart J. 2020 Jan 1;41(1):11–188.

⁴ Ray KK, et al. Treatment of high- and very high-risk patients for the prevention of cardiovascular events in Europe: baseline demographics from the multinational observational SANTORINI study. Presented at European Society Cardiology (ESC) Congress 2021. Poster ID 80441.

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 May 2022.

Contacts

Dr. Wolfgang Schiessl

Daiichi Sankyo Europe GmbH

Director PR and Portfolio Communications, Specialty Medicines

+49 151 1714 7317