Prescribing information (external link)
LEQVIO® (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:1
in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin, or
alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated
For full safety information, please refer to the LEQVIO® Summary of Product Characteristics (SmPC).
Cardiovascular risk
Nearly 1 in 5 (18.3%) of patients who suffer a myocardial infarction (MI) experience another cardiovascular risk (CV) event within 1 year*2
The effect of LEQVIO® on CV morbidity and mortality has not yet been determined.1
Early, intensive and sustained lipid-lowering is vital for reducing CV risk3,4
Achieving lipid target early and maintaining it at one year is associated with the lowest risk of a major adverse cardiovascular event (MACE) vs achieving target early and not maintaining it, achieving it late or never achieving it (HR=0.80; 95% CI: 0.74 to 0.86) vs never achieving target (N=56,262).3
Each 1 mmol/L reduction in LDL-C is associated with a 22% relative risk reduction in MACE (RR=0.78; 95% CI: 0.76 to 0.80).†4
The effect of LEQVIO® on CV morbidity and mortality has not yet been determined.1
Time to target in LDL-C management
Why time to target is critical in LDL-C management‡3,5
Non-HDL-C levels at MI admission, early and late goal achievement (N=46,518)3
Adapted from Schubert J, et al. 2024.3
This study reports non-HDL-C outcomes; however, current guidelines recommend LDL-C as the primary treatment target, with non-HDL-C recognised as an alternative target in certain settings. Most non-HDL-C comprises LDL-C.3
Long-term exposure to persistently high LDL-C can cause atherosclerotic cardiovascular disease (ASCVD) and associated CV events5
Log-linear association between LDL-C levels and risk of coronary heart disease (CHD)
Adapted from Ference B, et al. 2017.5
The proportional reduction in risk of CHD (y-axis) does not increase in regular increments. Please refer to the source for additional context. Results are from different studies that have different study populations and protocols. No direct comparisons should be made.5
LDL-C-lowering and plaque progression
Plaque regression increases with lowering LDL-C5
There is a clear correlation between LDL-C reduction and plaque regression5
Adapted from Ference B, et al. 2017.5
Results are from different studies that have different study populations and protocols. No direct comparisons should be made.5
The effect of LEQVIO® on plaque regression has not yet been determined.1
Challenges with lipid‐lowering therapy (LLT) adherence
Poor adherence to LLT and discontinuation can lead to poor CV outcomes for patients6,7
For patients with CHD on LLT for 12 months7
Impact of LLT adherence on CV outcomes
For patients with CHD on LLT‖8
The effect of LEQVIO® on CV morbidity and mortality has not yet been determined.1
When statins alone are not enough to reach LDL-C targets, national guidance recommends LEQVIO® as an option in eligible patients.9
Resource
LEQVIO®: A practical guide
Your Guide to LEQVIO®
A quick-guide to LEQVIO®, with information on NICE guidance and the NHS commercial agreement through to dosing and administration.
View the guidelines and sequencing for LEQVIO®
Click here to access resources about LEQVIO® for you and your patients
**Based on a retrospective cohort study of patients with primary MI between July 2006 and June 2011 from Swedish national registries. The MI population consisted of 97,254 patients who were alive 1 week after discharge.2
†Based on a meta-analysis of data from randomised statin trials over an average of 4.9 years (N=169,138). MACE include fatal MI or fatal stroke.4
‡Based on SWEDEHEART registry data. Patients who failed to achieve a non-HDL-C goal of <2.2 mmol/L at 1 year after the index MI (Never, n=22,005) were compared with those who: 1) Achieved the goal at the 2-month follow-up but it was not maintained at the 1-year visit (Early, n=5,379); 2) Did not achieve the goal at 2-month follow-up but achieved it at the 1-year visit (Late, n=7,050); 3) Achieved the goal at the 2-month follow-up and it was sustained at the 1-year visit (Early and sustained, n=12,084).3
§Versus those achieving it early and not maintaining it, achieving it late or never achieving it.3
¶A total of 3,046 patients experience MACE.7
‖Dose response meta-analysis of 17 studies to evaluate association between LLT medication adherence levels and CV events (defined as any fatal or non-fatal CHD, MI, HF, ischaemic heart disease or stroke or sudden cardiac death) in real-world settings. Data were collected on 187,306 CV events.8
ACS, acute coronary syndrome; ASCVD, atherosclerotic cardiovascular disease; CHD, coronary heart disease; CI, confidence interval; CV, cardiovascular; CVD, cardiovascular disease; HDL-C, high-density lipoprotein cholesterol; HF, heart failure; HR, hazard ratio; LDL-C, low-density lipoprotein cholesterol; LLT, lipid‐lowering therapy; MACE, major adverse cardiovascular event; MI, myocardial infarction; PDC, proportion of days covered; RR, relative risk; SmPC, summary of product characteristics.
References
LEQVIO® Summary of Product Characteristics.
Jernberg T, et al. Eur Heart J 2015;36:1163–1170.
Schubert J, et al. Eur Heart J 2024;45:4204–4215.
Cholesterol Treatment Trialists’ (CTT) Collaboration. Lancet 2010;376:1670–1681.
Ference B, et al. Eur Heart J 2017;38:2459–2472.
Maningat P, et al. Curr Atherosclerosis Rep 2013;15(1):291.
Mazhar F, et al. J Am Heart Assoc 2022;11(14):e025813.
Liu M, et al. J Cardiovasc Dev Dis 2021;8(11):146.
NHS England. Summary of National Guidance for Lipid Management for Primary and Secondary Prevention of CVD. Available at: https://www.england.nhs.uk/aac/wp-content/uploads/sites/50/2020/04/lipid-management-pathway-v6.pdf [Accessed April 2026].
LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.
UK | April 2026 | FA-11605519
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
