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
Please refer to the LEQVIO® Summary of Product Characteristics (SmPC) for full safety information, and the safety profile page here.
Initiating LEQVIO® in secondary care: a real-world perspective
Two years of LEQVIO® in a secondary prevention clinic2
Eight patients experienced major adverse cardiovascular events: STEMI (4), NSTEMI (3) and stroke (1)
Three patients developed mild injection-site skin rash
The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.1
Observational data. Results must be interpreted with caution.
mean LDL-C reduction from 3.48 mmol/L to 1.63 mmol/L (p<0.05) (n=101)2
of patients achieved ≥50% reduction in LDL-C (n=57)2
of patients attained LDL-C<1.4 mmol/L (n=44)2
Aligning with 2025 ESC/EAS LDL-C target guidelines3
High-risk patients: <1.8 mmol/L and a ≥50% reduction from baseline is recommended
Very high-risk patients: <1.4 mmol/L and a ≥50% reduction from baseline is recommended
Patients treated with LEQVIO® experienced a 33.5% reduction in mean total cholesterol from 5.5 mmol/L to 3.5 mmol/L (p<0.05; n=101)2
Study design:2
A 2-year observational study evaluating the real-world effectiveness and safety profile of LEQVIO® in patients with established ischaemic heart disease, attending a dedicated secondary prevention clinic (established September 2023) at Queen Elizabeth Hospital, Birmingham.
Baseline characteristics2 | |
Characteristic | Values |
Number of patients (n) | 105* |
Mean age (years, ±SD) | 66.6±10.9 |
Sex distribution: male (%) | 72.4 |
Stable angina (%) | 75.2 |
Unstable angina (%) | 2.9 |
NSTEMI (%) | 13.3 |
STEMI (%) | 8.6 |
Baseline statin therapy (%) | 57.1 |
Whilst LEQVIO® was generally well tolerated, the following adverse events were reported:2
In pivotal clinical studies, adverse reactions at the injection site were the only common reported adverse reactions (8.2% vs placebo 1.8%). Please refer to the SmPC for full information about the safety profile.1
Initiating LEQVIO® (inclisiran) in secondary care: a real-world perspective
Explore 2 years of real-world experience from the dedicated LEQVIO® clinic established by Dr Sohail Khan at Queen Elizabeth Hospital, Birmingham.
LEQVIO® discharge summary checklist
Help ensure continuity of LDL-C management in the community with this practical primary-care checklist. This checklist is intended as a practical aid only and does not constitute comprehensive clinical guidance.
Learn more about the LEQVIO® safety profile
Learn more about the efficacy of LEQVIO® in clinical trials
The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been established.1
*101 patients completed follow-up.2
EAS, European Atherosclerosis Society; ESC, European Society of Cardiology; LDL-C, low-density lipoprotein cholesterol; NSTEMI, non-ST-segment elevation myocardial infarction; SD, standard deviation; SmPC, summary of product characteristics; STEMI, ST-segment elevation myocardial infarction.
References
LEQVIO® Summary of Product Characteristics.
Al-Shatanawi A, et al. Astract 281. Heart 2026;112(Suppl 1):A220.
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 | July 2026 | FA-11727857
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.
