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Prescribing Information and Adverse Event Reporting (links to external website):

Guidance

Setting and achieving LDL-C lowering treatment targets

Guidelines provide evidence-based treatment targets, proven to be both clinically-effective and cost-effective.1–3

Concomitant use of NUSTENDI®/NILEMDO® with simvastatin >40 mg daily is contraindicated; please refer to the relevant SmPC for more information.4,5

The updated ESC/EAS 2025 dyslipidaemia guidelines provide recommendations on lipid modification strategies for managing dyslipidaemias to reduce CV risk.3

The 2025 focused update of the ESC/EAS 2019 Guidelines recommends non-statin LDL-C lowering agents with proven CV benefit, including bempedoic acid to reduce CV risk and lower LDL-C, if LDL-C goals are not met with the maximum tolerated dose of a statin.3

The 2025 focused update of the 2019 ESC/EAS guidelines for the management of dyslipidaemias recommends risk-stratified LDL-C lowering in patients not at target.3
LDL-C levels of <1.8 mmol/L have been associated with plaque regression and stabilisation7,8

*Class of recommendation definitions: Class I – is recommended or is indicated; Class IIa – should be considered; Class IIb – may be considered; Class III – is not recommended.3
Level of evidence definitions: A – Data derived from multiple randomised clinical trials or meta-analyses; B – Data derived from a single randomised clinical trial or large non-randomised studies; C – Consensus of opinion of the experts and/or small studies, retrospective studies, registries.3
Ezetimibe, PCSK9 monoclonal antibodies, bempedoic acid.3
§ESC/EAS 2025 guidelines definitions: Extreme risk: Patients with ASCVD who experience recurrent vascular events while taking maximally tolerated statin-based therapy; patients with polyvascular (e.g. coronary and peripheral) arterial disease. Very high risk: defined as people with any of the following: documented ASCVD, either clinical or unequivocal on imaging; documented ASCVD includes previous ACS (MI or unstable angina), chronic coronary syndromes, coronary revascularisation (PCI, CABG, and other arterial revascularisation procedures), stroke and TIA, and peripheral arterial disease. Unequivocally documented ASCVD on imaging includes those findings that are known to be predictive of clinical events, such as significant plaque on coronary angiography or CT scan or on carotid or femoral ultrasound or markedly elevated CAC score by CT.# DM with target organ damage,Δ or at least three major risk factors, or early onset of T1DM of long duration (>20 years); severe CKD (eGFR <30 mL/min/1.73m2); a calculated SCORE2 or SCORE2-OP ≥20% for 10-year risk of fatal or non-fatal CVD; FH with ASCVD or with another major risk factor. High risk: defined as people with any of the following: markedly elevated single risk factors, in particular TC >8 mmol/L (>310 mg/dL), LDL-C >4.9 mmol/L (>190 mg/dL), or BP ≥180/110 mmHg; patients with FH without other major risk factors; patients with DM without target organ damage,Δ with DM duration ≥10 years or another additional risk factor; moderate CKD (eGFR 30–59 mL/min/1.73 m2); a calculated SCORE2 or SCORE2-OP ≥10% and <20% for 10-year risk of fatal or non-fatal CVD. Moderate risk: defined as people with any of the following: young patients (T1DM <35 years; T2DM <50 years) with DM duration <10 years, without other risk-factors; a calculated SCORE2 or SCORE2-OP ≥2% and <10% for 10-year risk of fatal or non-fatal CVD. Low risk: defined as a calculated SCORE2 or SCORE2-OP <2% for 10-year risk of fatal or non-fatal CVD.3
Class IIa for individuals in primary prevention with FH at very high risk.3
Typically defined by >50% stenosis.3
#e.g. CAC score >300.3
ΔTarget organ damage is defined as microalbuminuria, retinopathy, or neuropathy.3

Concomitant use of NUSTENDI®/NILEMDO® with simvastatin >40 mg daily is contraindicated; please refer to the relevant SmPC for more information.4,5

The NICE NG238 and AAC guidance covers lipid management and treatment targets for primary and secondary prevention of CVD.1,2

Treatment targets and Treatment escalation

Concomitant use of NUSTENDI®/NILEMDO® with simvastatin >40 mg daily is contraindicated; please refer to the relevant SmPC for more information.4,5

References

  1. National Institute for Health and Care Excellence. Cardiovascular disease: risk assessment and reduction, including lipid modification [NG238]. December 2023. Available at: https://www.nice.org.uk/guidance/ng238/chapter/Recommendations Accessed: April 2026.
  2. NHS England. Summary of national guidance for lipid management. September 2024. Available at: https://www.england.nhs.uk/aac/publication/summary-of-national-guidance-for-lipid-management/ Accessed: April 2026.
  3. Mach F, et al. Eur Heart J. 2025; 46:4359–4378.
  4. NUSTENDI® Summary of Product Characteristics.
  5. NILEMDO® Summary of Product Characteristics.
  6. Mach F, et al. Eur J Heart. 2020;41:111–188.
  7. Masana L, et al. Pharmacol Res. 2023;190:106738.
  8. Nicholls SJ, et al. JAMA. 2016;316(22):2373–2384.
  9. NICE. Bempedoic acid with ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia [TA694]. Available at: https://www.nice.org.uk/guidance/ta694. Accessed: April 2026.
  10. NHS England. Quality and Outcomes Framework Guidance for 2026/27. March 2026. Available at: https://www.england.nhs.uk/wp-content/uploads/2026/03/PRN02356-quality-and-outcomes-framework-guidance-26-27.pdf Accessed: April 2026.

Abbreviations

AAC, Accelerated Access Collaborative; ACS, acute coronary syndromes; ASCVD, atherosclerotic cardiovascular disease; BMI, body mass index; BP, blood pressure; CABG, coronary artery bypass graft surgery; CAC, coronary artery calcium; CHOL, cholesterol; CKD, chronic kidney disease; CT, computed tomography; CV, cardiovascular; CVD, cardiovascular disease; DM, diabetes mellitus; EAS, European Atherosclerosis Society; eGFR, estimated glomerular filtration rate; ESC, European Society of Cardiology; FH, familial hypercholesterolaemia; HbA1c, haemoglobin A1c; HDL-C, high-density lipoprotein cholesterol; LDL, low-density lipoprotein; LDL-C, low-density lipoprotein cholesterol; LLT, lipid-lowering therapy; MI, myocardial infarction; NG28, NICE Guideline 28; NICE, National Institute for Health and Care Excellence; PCI, percutaneous coronary intervention; PCSK9, proprotein convertase subtilisin/kexin type 9; QOF, Quality and Outcomes Framework; SCORE2, Systematic Coronary Risk Evaluation 2; SCORE2-OP, Systematic Coronary Risk Evaluation 2-Older Persons; SmPC, Summary of Product Characteristics; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus; TC, total cholesterol; TIA, transient ischaemic attack.

Job code: UK/BIL/04/26/0001|Date of preparation: April 2026

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