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Observational Study
. 2024 Nov 11;31(15):1792-1803.
doi: 10.1093/eurjpc/zwae199.

Use of combination therapy is associated with improved LDL cholesterol management: 1-year follow-up results from the European observational SANTORINI study

Kausik K Ray  1 , Carlos Aguiar  2 , Marcello Arca  3 , Derek L Connolly  4   5 , Mats Eriksson  6 , Jean Ferrières  7 , Ulrich Laufs  8 , Jose M Mostaza  9 , David Nanchen  10 , Aurélie Bardet  11 , Mathias Lamparter  11 , Richa Chhabra  11 , Jarkko Soronen  11 , Ernst Rietzschel  12 , Timo Strandberg  13   14 , Hermann Toplak  15 , Frank L J Visseren  16 , Alberico L Catapano  17   18 ; SANTORINI Study Investigators
Collaborators, Affiliations
Observational Study

Use of combination therapy is associated with improved LDL cholesterol management: 1-year follow-up results from the European observational SANTORINI study

Kausik K Ray et al. Eur J Prev Cardiol. .

Abstract

Aims: To assess whether implementation of the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) dyslipidaemia guidelines observed between 2020 and 2021 improved between 2021 and 2022 in the SANTORINI study.

Methods and results: Patients with high or very high cardiovascular (CV) risk were recruited across 14 European countries from March 2020 to February 2021, with 1-year prospective follow-up until May 2022. Lipid-lowering therapy (LLT) and 2019 ESC/EAS risk-based low-density lipoprotein (LDL) cholesterol (LDL-C) goal attainment (defined as <1.4 mmol/L for patients at very high CV risk and <1.8 mmol/L for patients at high CV risk) at 1-year follow-up were compared with baseline. Of 9559 patients enrolled, 9136 (2626 high risk and 6504 very high risk) had any available follow-up data, and 7210 (2033 high risk and 5173 very high risk) had baseline and follow-up LDL-C data. Lipid-lowering therapy was escalated in one-third of patients and unchanged in two-thirds. Monotherapy and combination therapy usage rose from 53.6 and 25.6% to 57.1 and 37.9%, respectively. Mean LDL-C levels decreased from 2.4 to 2.0 mmol/L. Goal attainment improved from 21.2 to 30.9%, largely driven by LLT use among those not on LLT at baseline. Goal attainment was greater with combination therapy compared with monotherapy at follow-up (39.4 vs. 25.5%).

Conclusion: Lipid-lowering therapy use and achievement of risk-based lipid goals increased over 1-year follow-up particularly when combination LLT was used. Nonetheless, most patients remained above goal; hence, strategies are needed to improve the implementation of combination LLT.

Keywords: Cardiovascular risk; Dyslipidaemia; Europe; Lipid; Real-world clinical trials.

Plain language summary

Cardiovascular (CV) diseases, a group of disorders of the heart and blood vessels, are the most common cause of death worldwide. Lowering LDL cholesterol (LDL-C) in the bloodstream reduces the risk of the development of CV diseases such as heart attacks and strokes. Guidelines recommend that those at the highest risk of CV disease should achieve the lowest levels of LDL-C. Several medications are available that help lower LDL-C levels and prevent CV events; however, recent studies have shown that the majority of patients continue to have LDL-C levels above optimal value in part due to a suboptimal use of these medications. In this study, we report the results after 1 year of follow-up of the SANTORINI study (started in 2020), which aimed to document the management of LDL-C in clinical practice across 14 countries in Europe. We found that a better control of LDL-C occurred when more than one drug was used (combination therapy). The use of combination therapy was low at the start of the study (25.6%) but increased over 1 year to 37.9%, resulting in a better control of LDL-C at 1 year than observed at the start of the study. Nonetheless, only 31% of patients achieved their LDL-C target levels based on the European guidelines. A greater use of combination therapies is needed in order to improve the overall population-level control of LDL-C.

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Conflict of interest statement

Conflict of interest: K.K.R. has received honoraria for consulting, lectures from Abbott Laboratories, Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Cargene, CRISPR, Daiichi Sankyo, Eli Lilly Company, Emendobio, Esperion, Kowa, New Amsterdam Pharma, Novartis Corporation, Nodthera, GSK, Novo Nordisk, Pfizer, Regeneron, Sanofi, SCRIBE, Silence Therapeutics, and VAXXINITY. In addition, he has received research grant support to his institution from Amgen, Daiichi Sankyo, Sanofi, Regeneron, and Ultragenyx, plus stock options from New Amsterdam Pharma, Scribe, and Pemi 31. A.L.C. received research grant support from Amryt Pharma, Menarini, Ultragenyx, and Viatris, and lecturing fees from Amarin, Amgen, Amryt Pharma, AstraZeneca, Daiichi Sankyo, Esperion, Ionis Pharmaceutical, Medscaper, Menarini, Merck, Novartis, Peervoice, Pfizer, Recordati, Regeneron, Sandoz, Sanofi, The Corpus, Ultragenyx, and Viatris. M.A. received research grant support and lecturing fees from Alfasigma, Amgen, Amryt, Daiichi Sankyo, Ionis Pharmaceuticals/Akcea Therapeutics, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sobi, Viatris, and Ultragenyx. A.B., R.C., M.L., and J.S. are employees of Daiichi Sankyo. H.T. received grant support and lecturing fees from Daiichi Sankyo and participated in an advisory board run by Daiichi Sankyo. T.S. received consulting fees from Amgen, Novartis, Orion Pharma, and Valio, and lecturing fees from Amarin, Pfizer, and GSK. He is a patient on statin and ezetimibe therapy. U.L. received grant support from Daiichi Sankyo, Novartis, and Amgen and lecturing fees from Daiichi Sankyo, Novartis, Amgen, Sanofi, Boehringer, MSD, Pfizer, Lilly, and AstraZeneca. He has also been a member of advisory boards for Daiichi Sankyo, Novartis, Amgen, Sanofi, Boehringer, and MSD, in addition to donning leadership/fiduciary roles with EAS, ESC, DGK, and DACH.

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