Lipid-lowering therapy and risk-based LDL-C goal attainment in Belgium: DA VINCI observational study

Borne, Philippe van de; Peeters, André; Janssens, Luc; Leone, Attilio; Lemmens, Robin; Verhaegen, Ann; Meulemeester, Marc De; Balthazar, Yohan; Heijmans, Stéphane; Calozet, Yvan; Paquot, Nicolas; Carlier, Stéphane; Hemelsoet, Dimitri; Bray, Sarah; Ray, Kausik K.

doi:10.1080/00015385.2022.2030568

Cited by 10 publications

(6 citation statements)

References 26 publications

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“…The DA VINCI study found that out of 5888 patients with dyslipidaemia who were enrolled in 18 European countries, only 33% achieved their risk-based LDL-C goal recommended in the European Society of Cardiology (ESC) 2019 guidelines [ 12 ]. These results were consistent across European countries [ 13 – 15 ]. Accordingly, an Australian study of 61,407 patients reported that only 36% achieved their recommended LDL-C levels [ 16 ].…”

Section: Introductionsupporting

confidence: 76%

Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention

Michaeli

Albers

et al. 2023

Am J Cardiovasc Drugs

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Despite treatment with statins, patients with elevated low-density lipoprotein cholesterol (LDL-C) and triglycerides remain at increased risk for adverse cardiovascular events. Consequently, novel pharmaceutical drugs have been developed to control and modify the composition of blood lipids to ultimately prevent fatal cardiovascular events in patients with dyslipidaemia. This article reviews established and emerging lipid-lowering drugs regarding their mechanism of action, development stage, ongoing clinical trials, side effects, effect on blood lipids and reduction in cardiovascular morbidity and mortality. We conducted a keyword search to identify studies on established and emerging lipid modifying drugs. Results were summarized in a narrative overview. Established pharmaceutical treatment options include the Niemann-Pick-C1 like-1 protein (NPC1L1) inhibitor ezetimibe, the protein convertase subtilisin-kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab, fibrates as peroxisome proliferator receptor alpha (PPAR-α) activators, and the omega-3 fatty acid icosapent ethyl. Statins are recommended as the first-line therapy for primary and secondary cardiovascular prevention in patients with hypercholesterinaemia and hypertriglyceridemia. For secondary prevention in hypercholesterinaemia, second-line options such as statin add-on or statin-intolerant treatments are ezetimibe, alirocumab and evolocumab. For secondary prevention in hypertriglyceridemia, second-line options such as statin add-on or statin-intolerant treatments are icosapent ethyl and fenofibrate. Robust data for these add-on therapeutics in primary cardiovascular prevention remains scarce. Recent biotechnological advances have led to the development of innovative small molecules (bempedoic acid, lomitapide, pemafibrate, docosapentaenoic and eicosapentaenoic acid), antibodies (evinacumab), antisense oligonucleotides (mipomersen, volanesorsen, pelcarsen, olezarsen), small interfering RNA (inclisiran, olpasiran), and gene therapies for patients with dyslipidemia. These molecules specifically target new cellular pathways, such as the adenosine triphosphate-citrate lyase (bempedoic acid), PCSK9 (inclisiran), angiopoietin-like 3 (ANGPTL3: evinacumab), microsomal triglyceride transfer protein (MTP: lomitapide), apolipoprotein B-100 (ApoB-100: mipomersen), apolipoprotein C-III (ApoC-III: volanesorsen, olezarsen), and lipoprotein (a) (Lp(a): pelcarsen, olpasiran). The authors are hopeful that the development of new treatment modalities alongside new therapeutic targets will further reduce patients’ risk of adverse cardiovascular events. Apart from statins, data on new drugs’ use in primary cardiovascular prevention remain scarce. For their swift adoption into clinical routine, these treatments must demonstrate safety and efficacy as well as cost-effectiveness in randomized cardiovascular outcome trials.

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Section: Introductionsupporting

confidence: 76%

Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention

Michaeli

Albers

et al. 2023

Am J Cardiovasc Drugs

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“…Many patients in routine clinical practice remain suboptimally treated and thus at increased cardiovascular (CV) risk; as a result, they need intensification of LLT for further LDL‑C lowering. Statins plus ezetimibe will only achieve LDL‑C goals on average in about 40–45% of high and very high risk patients, meaning that at least one third of these patients will require use of additional oral therapy or injectable PCSK9 inhibitor [ 6 , 15 , 17 , 19 – 21 ] or inclisiran.…”

Section: Introductionmentioning

confidence: 99%

Simulation of bempedoic acid and ezetimibe in the lipid-lowering treatment pathway in Austria using the contemporary SANTORINI cohort of high and very high risk patients

Toplak,

Bilitou,

Alber

et al. 2023

Wien Klin Wochenschr

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Summary Objective The low-density lipoprotein cholesterol goals in the 2019 European Society of Cardiology/European Atherosclerosis Society dyslipidaemia guidelines necessitate greater use of combination therapies. We describe a real-world cohort of patients in Austria and simulate the addition of oral bempedoic acid and ezetimibe to estimate the proportion of patients reaching goals. Methods Patients at high or very high cardiovascular risk on lipid-lowering treatments (excluding proprotein convertase subtilisin/kexin type 9 inhibitors) from the Austrian cohort of the observational SANTORINI study were included using specific criteria. For patients not at their risk-based goals at baseline, addition of ezetimibe (if not already received) and subsequently bempedoic acid was simulated using a Monte Carlo simulation. Results A cohort of patients (N = 144) with a mean low-density lipoprotein cholesterol of 76.4 mg/dL, with 94% (n = 135) on statins and 24% (n = 35) on ezetimibe monotherapy or in combination, were used in the simulation. Only 36% of patients were at goal (n = 52). Sequential simulation of ezetimibe (where applicable) and bempedoic acid increased the proportion of patients at goal to 69% (n = 100), with a decrease in the mean low-density lipoprotein cholesterol from 76.4 mg/dL at baseline to 57.7 mg/dL overall. Conclusions The SANTORINI real-world data in Austria suggest that a proportion of high and very high-risk patients remain below the guideline-recommended low-density lipoprotein cholesterol goals. Optimising use of oral ezetimibe and bempedoic acid after statins in the lipid-lowering pathway could result in substantially more patients attaining low-density lipoprotein cholesterol goals, likely with additional health benefits.

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“…The combination of high intensity statin, ezetimibe, and PCSK9 inhibitor is potentially able to reduce LDL-C by 85% compared to baseline values, allowing the achievement of the therapeutic target in most cases ( Table 1 ). In the real world, however, it is clear that more than 80% of patients who require therapy with cholesterol-lowering drugs for either primary or secondary prevention of cardiovascular diseases do not reach the targets set in the 2019 guidelines ( 5 , 6 ). Failure to achieve those targets is associated to a significant increase in the number of cardiovascular events in the whole population.…”

Section: Introductionmentioning

confidence: 99%

Mechanism of action and therapeutic use of bempedoic acid in atherosclerosis and metabolic syndrome

Biolo

Vinci

Mangogna

et al. 2022

Front. Cardiovasc. Med.

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Bempedoic acid is a new cholesterol-lowering drug, which has recently received US FDA and EMA approval. This drug targets lipid and glucose metabolism as well as inflammation via downregulation of ATP-citrate lyase and upregulation of AMP-activated protein kinase (AMPK). The primary effect is the reduction of cholesterol synthesis in the liver and its administration is generally not associated to unwanted muscle effects. Suppression of hepatic fatty acid synthesis leads to decreased triglycerides and, possibly, improved non-alcoholic fatty liver disease. Bempedoic acid may decrease gluconeogenesis leading to improved insulin sensitivity, glucose metabolism, and metabolic syndrome. The anti-inflammatory action of bempedoic acid is mainly achieved via activation of AMPK pathway in the immune cells, leading to decreased plasma levels of C-reactive protein. Effects of bempedoic acid on atherosclerotic cardiovascular disease, type 2 diabetes and chronic liver disease have been assessed in randomized clinical trials but require further confirmation. Safety clinical trials in phase III indicate that bempedoic acid administration is generally well-tolerated in combination with statins, ezetimibe, or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors to achieve low-density lipoprotein cholesterol targets. The aim of this narrative review on bempedoic acid is to explore the underlying mechanisms of action and potential clinical targets, present existing evidence from clinical trials, and describe practical management of patients.

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Lipid-lowering therapy and risk-based LDL-C goal attainment in Belgium: DA VINCI observational study

Cited by 10 publications

References 26 publications

Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention

Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention

Simulation of bempedoic acid and ezetimibe in the lipid-lowering treatment pathway in Austria using the contemporary SANTORINI cohort of high and very high risk patients

Mechanism of action and therapeutic use of bempedoic acid in atherosclerosis and metabolic syndrome

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