Patients at high and very high cardiovascular risk, in acidity
In patients with high and very high risk hypercholesterolemia, optimization of oral therapies in combination with the combined use of to eat and bempedoic acid after statins, this could lead to a significantly higher number of patients reaching the LDL cholesterol (LDL-C) target values recommended by European guidelines, potentially reducing the risk of cardiovascular events. The new proof of Register SANTORINIa prospective observational study conducted in 14 European countries was presented at the Congress of the European Society of Cardiology.
Simulation of hypercholesterolemia risk reduction
Using the SANTORINI data, the researchers evaluated, by simulation, the addition of bempedoic acid to ezetimibe in patients at high and very high cardiovascular risk to determine the percentage of patients who could reach the lipid targets recommended by the European recommendations. Data presented today indicate that in patients taking ezetimibe who do not reach their LDL-C goal, the addition of bempedoic acid may result in an additional 36% (n=1222/3412) of the objective.
The analysis included a cohort of 6,177 patients receiving lipid-lowering therapy with baseline analyzes of LDL-C levels and cardiovascular risk. A treatment algorithm was applied to those who did not meet their LDL-C goals based on their risk stratification by first adding ezetimibe (if not already taking it) and then adding ezetimibe. bempedoic acid. Patients on treatment with a PCSK9i inhibitor were not included in the simulation phases, regardless of the achievement of the objectives. The reduction in LDL-C associated with treatment with ezetimibe and bempedoic acid was based on efficacy demonstrated in published clinical studies.
Overall, the number of patients reaching the target recommended by the European directive is expected to increase from 1,428 (23.1%) to 2,455 (39.7%) and 3,677 (59.5%) after the sequential addition of ezetimibe and bempedoic acid. Also, the average LDL-C should drop from 80.33 mg/dL to 69.28 mg/dL and 60.94 mg/dL this way.
2019 ESC/EAS guidelines for the management of dyslipidemia recommend target LDL-C levels
The simulation data presented today adds to the growing body of evidence that optimizing lipid-lowering therapy with the addition of bempedoic acid to ezetimibe could enable significantly more patients to achieve the recommended lipid targets and thus reduce the risk of atherosclerotic cardiovascular disease.
“This is the first simulation data from the SANTORINI Registry that allows us to assess the percentage of patients who could achieve the LDL-C goal when bempedoic acid is added to existing treatment algorithms,” said the teacher Rayon KausikProfessor of Public Health and President of the European Atherosclerosis Society, Honorary Consultant Cardiologist, Global Director of ICTU and Deputy Director of the Clinical Trials Unit at Imperial College London and Principal Investigator of SANTORINI: “We know that many at-risk patients are still not meeting recommended targets, and today’s data reinforces guideline recommendations that we need to intensify treatment for patients at higher risk of heart attack and stroke stroke to achieve LDL cholesterol targets in clinical practice and ultimately improve their outcomes.
Cardiovascular risk factors in patients with and without a history of atherosclerotic cardiovascular disease (ASCVD).
In a complementary sub-analysis of the SANTORINI registry, the cardiovascular risk of the 9,044 patients classified by the investigator according to the classification of the ESC/EAS 2019 recommendations was reassessed on the basis of the data available in the study database. Overall, 52% of investigators used the ESC/EAS guidelines for risk classification. Among all patients, the investigator assessed 26.0% and 84.2% of patients with and without atherosclerotic cardiovascular disease (ASCVD), respectively, as being at very high risk. Conversely, reassessment according to ESC/EAS guidelines revealed that 54.7% and 100% of patients without and with ASCVD, respectively, were at very high risk.
Cardiovascular risk factors and ASCVD were common in the SANTORINI study. Hypertension was the most common risk factor in patients with and without ASCVD, while diabetes and familial hypercholesterolemia were more common in patients without ASCVD than in patients with ASCVD (44.6% vs. 3% and 18.6% versus 7.2%). The management of ASCVD is linked to individual risk factors; The higher the risk, the more intensive the action must be. Therefore, it is important to accurately identify the level of risk to ensure a suitable solution for the prevention of atherosclerotic cardiovascular disease and reduce its impact on patients.
“The SANTORINI data presented at the ESC congress show that the cardiovascular risk of patients with and without atherosclerotic cardiovascular disease is underestimated in clinical practice, potentially limiting prevention across Europe,” said Dr. . Stefan SeifriedVice President of Medical Affairs, Specialty Medicine at Daiichi Sankyo Europe, who added, “Daiichi-Sankyo Europe understands the need to support and work with specialists to continue integrating EAS/ESC guidelines into daily clinical practice. We are committed to working with physicians to help reduce the number of lives affected by cardiovascular disease every day by first examining the real impact of these diseases on health care through studies like SANTORINI.
The SANTORINI study is a multinational prospective observational study which recruited 9,606 patients in more than 800 centers in 14 European countries. The primary objective is to document the efficacy of current treatment modalities on plasma LDL-C levels in high and very high risk patients requiring lipid-lowering therapies in a real-world setting. The study population includes both previously diagnosed and treated hypertension and hypertension patients and newly diagnosed patients requiring treatment.
Only data from day-to-day clinical practice is collected and physicians are not required to perform mandatory assessment outside of this practice. To help collect accurate data, patients can optionally fill out a note to record important details.
Bempedoic acid (marketed as NILEMDO in the European Economic Area, Turkey and Switzerland) is an innovative first-in-class treatment that lowers LDL cholesterol levels and can be combined with other oral treatments to reduce more cholesterol. Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme involved in the hepatic synthesis of cholesterol.
Bempedoic acid has been approved as an adjunct to the diet of adult patients with familial hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia:
- in combination with a statin or other lipid-lowering therapies in patients not achieving LDL-C goals at the maximum tolerated dose of a statin
- alone or in combination with other lipid-lowering treatments, in patients intolerant to statins or for whom statins are contraindicated.
Bempedoic acid acts on the well-known cholesterol synthesis process, upstream of the hepatic target of statins, with a unique mechanism of action that allows for further lowering of LDL-C levels when added to therapy with statins or other lipid-lowering therapies. Due to its novel mechanism of action, bempedoic acid is not active in skeletal muscle.
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