Therapy Areas: Cardiovascular
European Observational Study SANTORINI shows LDL-C Levels Remain Higher than Recommended Goals and Combination Therapies are Under-Utilised in Patients at Very High or High Cardiovascular Risk
31 August 2021 - - Japanese pharmaceutical company Daiichi Sankyo's (OTC: DSNKY) Daiichi Sankyo Europe business has presented inaugural data from SANTORINI, the first European observational study since the 2019 ESC/EAS management of dyslipidaemia guidelines to assess the management of high- and very high-risk cardiovascular patients requiring lipid-lowering therapy, at the ESC Congress 2021, organised by the European Society of Cardiology, the company said.

SANTORINI is a multinational, prospective, observational, non-interventional study, primarily designed to document, in routine clinical practice, the effectiveness of current treatment options for managing levels of LDL-C in these patients.

Results from the SANTORINI study, which has recruited 9,606 patients, show that at baseline, 18.6% of high- and very-high risk CV patients were not receiving any LLTs.

The majority of patients (54.1%) received LLT as monotherapy, and combination LLT was only used in 27.3% of patients.

The 2019 ESC/EAS management of dyslipidaemia guidelines recommend that the lower the levels of LDL-C for high- and very-high risk CV patients, the more their cardiovascular risk is reduced.

Given that 80% of hypercholesterolaemia patients are not reaching guideline-recommended LDL-C goals, despite receiving LLTs, the SANTORINI findings reaffirm the need for more intensive use of LLTs.

Contextual background: Simulation study data presented at ACC 2021 and published in the JACC anticipate a significant 10-year CV risk reduction when combination therapies are utilised

Earlier this year (May 2021), simulation data pooled from four completed pivotal randomised, double-blind, placebo-controlled, Phase 3 studies of bempedoic acid, were presented as a poster presentation at the American College of Cardiology's Scientific Session.

The study which used the validated Second Manifestations of ARTerial disease (SMART) model, and has since been published in The Journal of the American College of Cardiology (JACC), predicted a reduction in CV risk in patients with atherosclerotic cardiovascular disease (ASCVD), if treated with bempedoic acid.

The simulation study estimated that treatment with bempedoic acid on top of maximally tolerated statins would lead to a 3.3% absolute reduction in 10-year CV event risk compared with statins alone (p