Prescribing information (external link)

Hero banner. LEQVIO® (inclisiran) logo.
Hero banner. LEQVIO® (inclisiran) logo.

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).

LEQVIO® in a real-world setting

When statins alone are not enough to reach LDL-C targets, the NHS England Lipid Management Pathway recommends LEQVIO® as an option in eligible patients.2

In addition to its clinical trials programme, LEQVIO® has been evaluated in real‑world clinical practice.

V-INITIATE: a ‘LEQVIO® first’ approach after statins in a real-world setting3

  • Key findings
  • Study design
  • Safety profile

    Significant LDL-C reduction achieved with a ‘LEQVIO® first’ approach after statins3

    LEQVIO® as a first-line add-on therapy after statins + usual care vs usual care in patients who failed to reach LDL-C<1.8 mmol/L.3

     

    Co-primary endpoint: ‘LEQVIO® first’ approach had a greater reduction in LDL-C from baseline (BL) to Day 330 compared with usual care

    Graph showing Mean change in LDL-C from baseline to day 330 with 'LEQVIO® first' vs. ususal care.'LEQVIO® first' approach had a greater reduction in LDL-C from baseline to Day 330 compared with usual care.

    Adapted from Koren MJ, et al. 2024.3

     

    60% LDL-C reduction from BL to Day 330: ‘LEQVIO® first’ (97.5% CI: −64.7% to −55.2%) vs 7% with usual care (97.5% CI: −12.0% to −1.9%).3
    BL mean (±SD) LDL-C: ‘LEQVIO® first’ 2.5±0.86 mmol/L; usual care 2.5±0.84 mmol/L3

     

    Co-primary endpoint: statin discontinuation rates* were non-inferior with a ‘LEQVIO® first’ approach compared with usual care

    Graph showing the proportion of patients discontinuing statin therapy with 'LEQVIO® first' vs. ususal care. Statin discontinuation rates were non-inferior with a 'LEQVIO® first' approach compared with usual care.

    Adapted from Koren MJ, et al. 2024.3

    The difference between the statin discontinuation rates* was −10.6% (within non-inferiority margin): 6.0% with ‘LEQVIO® first’ (97.5% CI: 1.9% to 10.2%) vs 16.7% with usual care (97.5% CI: 10.2% to 23.1%).3

     

    At Day 330, mean LDL-C percentage change from BL was significantly greater with ‘LEQVIO® first’ vs usual care with a between-group difference of −53.0% (97.5% CI: −60.0% to −46.0%; p<0.001)3

    Study design:3

    V-INITIATE was a 12-month, randomised, open-label, Phase IIIb study in adults with atherosclerotic cardiovascular disease (ASCVD) (N=450) receiving maximally tolerated statin therapy or with documented statin intolerance. The study evaluated the early initiation of LEQVIO® immediately upon failure to reach LDL-C<1.8 mmol/L on maximally tolerated statin vs usual care in a real-world setting. Participants were randomised 1:1 to receive subcutaneous LEQVIO® sodium 300 mg† + usual care (‘LEQVIO® first’) or usual care. Those assigned to ‘LEQVIO® first’ received doses on Days 0, 90 and 270 + usual care. Day 330 was the primary analysis timepoint.

     

    Study population:3

    • Aged ≥18 years with a history of ASCVD‡

    • LDL-C≥1.8 mmol/L or non-HDL-C≥2.6 mmol/L and fasting triglycerides <5.7 mmol/L

    • Receiving maximally tolerated statin therapy§ or had documented statin intolerance

     

    Usual care:3

    • HCP-determined based on the 2018 AHA/ACC guidelines

    • Most participants (73%) remained on statins only‖

    • Twenty participants received statins + ezetimibe, five received other combinations including PCSK9 mAbs and five received PCSK9 mAb monotherapy

     

    • The most common treatment-emergent adverse events were COVID-19 (8.5% vs 6.9%), increased blood creatine phosphokinase (4.3% vs 6.0%) and injection-site pain (7.7% vs 0%) for ’LEQVIO® first’ and usual care, respectively3

V-INCEPTION: a ‘LEQVIO® first’ approach after statins following acute coronary syndrome (ACS) in a real-world setting4

  • Key findings
  • Study design
  • Safety profile

    Significant LDL-C reduction achieved with a ‘LEQVIO® first’ approach after statins4

    LEQVIO® + usual care (‘LEQVIO® first’) vs usual care in patients with a recent hospitalisation for ACS.

    Co-primary endpoint: percentage change in LDL-C from BL at Day 330

    Graph showing LS mean change in LDL-C from baseline up to day 330, with 'LEQVIO® first' vs. usual care. There was a -45.6% LDL-C change from BL with 'LEQVIO® first' vs. +1.4% with usual care alone at day 330.

    Adapted from Knowlton  KU, et al. 2026.4

    −45.6% LDL-C change from BL with ‘LEQVIO® first’ vs +1.4% with usual care alone at Day 330.4
    BL LDL-C: LEQVIO® 2.20 mmol/L (1.91–2.69) vs usual care alone 2.15 mmol/L (1.81–2.64)4

     

    Improved target achievement with ‘LEQVIO first’ after statins vs usual care alone post-ACS4

    Patients achieving LDL-C target by Day 330

    Graphic showing the percentage of patients achieving LDL-C target by day 330. 66.7% of patients on 'LEQVIO first strategy (n=201) achieved the LDL-C target of <1.8 mmol/L. by day 330 versus 28.1% of patients on usual care (n=199). Graphic showing the percentage of patients achieving LDL-C target by day 330. 54.2% of patients on LEQVIO first strategy (n=201) achieved the LDL-C target of <1.4 mmol/L. by day 330 versus 13.6% of patients on usual care (n=199).

    2025 ESC/EAS LDL-C target guideline:5

    High-risk patients: <1.8 mmol/L and a ≥50% reduction from BL

    Study design:4

    V-INCEPTION was an 11-month, randomised, open-label, Phase IIIb study in adults with recent ACS (N=400) receiving statin therapy or with documented statin intolerance. The study evaluated the initiation of LEQVIO® ≤5 weeks after ACS hospitalisation discharge vs usual care in a setting designed to mimic real-world practice. Participants were randomised 1:1 to receive subcutaneous LEQVIO® sodium 300 mg† + usual care (‘LEQVIO® first’) or usual care. Those assigned to ‘LEQVIO® first’ received doses on Days 0, 90 and 270 + usual care. Day 330 was the primary analysis timepoint.

    Study population:4

    • ACS hospitalisation ≤5 weeks before visit 1

    • Aged ≥18 years

    • LDL-C≥1.8 mmol/L or non-HDL-C≥2.6 mmol/L

    • Receiving statin therapy or had documented statin intolerance

     

    Usual care:4

    • HCP-determined, as deemed clinically appropriate

    • Usual care in both arms included statin therapy and non-statin lipid-lowering therapy (LLT)

    • Non-statin LLT included ezetimibe, anti-PCSK9 mAbs, bempedoic acid and LEQVIO® (if acquired through commercial means in the usual care arm)

    • Patients receiving LEQVIO® could not receive anti-PCSK9 mAbs

    • Overall, adverse event (AE) rates were similar with ‘LEQVIO® first’ (58.6%) vs usual care alone (53.3%)4

    • Injection-site reactions were the most common treatment-related AE with ‘LEQVIO® first’ (7.9%) vs usual care alone (0%); all were mild or moderate4

    • There were no treatment-related serious AEs with ‘LEQVIO® first’ or usual care alone4

    • There were no fatal AEs with ‘LEQVIO® first’ vs 1.0% with usual care alone4

Real-own experience of LEQVIO® in the primary care setting

Explore real‑world data from Dr Carl Deaney evaluating LEQVIO® in 102 patients in a UK primary care setting.

Learn more

Real-own experience of LEQVIO® in the secondary care setting

Discover how LEQVIO® has been implemented in the secondary care setting with expert perspective from Dr Sohail Khan.

Learn more

Learn more about the safety profile of LEQVIO®

Find out more

The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been established.1

*Defined as no statin use ≥30 days before the EOS, assessed in patients with no history of statin intolerance.3
†Equivalent to 284 mg LEQVIO®.1,3
‡Coronary heart disease, cerebrovascular disease or peripheral arterial disease.3
§Maximally tolerated statin therapy was determined by the investigator, no immediate plans to modify LLT were permitted.3
Documented side effects on ≥2 different statins, including one at the lowest standard dose.3
‖Ten (4.3%) participants received LEQVIO® after being randomised to usual care.3

ACC, American College of Cardiology; ACS, acute coronary syndrome; AE, adverse event; AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; BL, baseline; CI, confidence interval; COVID-19; coronavirus disease 2019; EAS, European Atherosclerosis Society; EOS, end of study; ESC, European Society of Cardiology; HCP, healthcare professional; HDL-C, high-density lipoprotein; LDL-C, low-density lipoprotein cholesterol; LLT, lipid-lowering therapy; LS, least squares; mAb, monoclonal antibody; PCSK9, proprotein convertase subtilisin/kexin type 9; SD, standard deviation; SmPC, summary of product characteristics.

References

  1. LEQVIO® Summary of Product Characteristics.

  2. 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 August 2026].

  3. Koren MJ, et al. J Am Coll Cardiol 2024;83(20):1939–1952

  4. Knowlton KU, et al. J Am Heart Assoc 2026;15(10):e043655.

  5. Mach F, et al. Eur Heart J 2025;46(2):4359–4378.

LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.

UK | August 2026 | FA-11727885

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.