Inclisiran is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach 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.1
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After an initial dose, inclisiran is administered again at 3 months, followed by every 6 months.
Inclisiran is the first and only siRNA LDL-C-lowering therapy1,3,4
Inclisiran has been identified by NHSEI as a medicine that it wishes to adopt systematically and at scale to help tackle lipid management in a large high-risk patient population. A collaboration between Novartis and NHS England delivered by the AAC and the AHSN Network uses a population health management approach to offer inclisiran treatment to at-risk ASCVD patients in primary care5
Inclisiran delivered effective and sustained LDL-C reduction, in combination with a maximally tolerated statin, in patients with ASCVD (or risk equivalents)‡§2
Inclisiran was generally well-tolerated in three Phase III trials, with a safety profile similar to placebo apart from injection-site reactions, which were more common in the inclisiran group2,6
For further information please refer to the Summary of Product Characteristics by clicking here.
‡ At Month 17, inclisiran delivered placebo-corrected LDL-C reductions of 52%, as compared with baseline (95% CI: −55.7 to −48.8; P<0.0001) in ORION-10, and of 50%, as compared with baseline (95% CI: −53.1 to −46.6; P<0.0001) in ORION-11, with respective time-adjusted LDL-C reductions of 54% (95% CI: −56.2 to −51.3; P<0.0001) and of 49% (95% CI: −51.6 to −46.8; P<0.0001) from baseline between Months 3 and 18 relative to placebo.1,2
§ ASCVD was defined as coronary heart disease, cerebrovascular disease or peripheral arterial disease.7 ASCVD risk equivalents included type 2 diabetes, FH, or a 10-year risk of a cardiovascular event of ≥20% as assessed by the Framingham Risk Score for Cardiovascular Disease or equivalent.2
AAC Accelerated Access Collaborative; AHSN Academic Health Science Networks; ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; FH, familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol; NHS, National Health Service; NHSEI NHS England and NHS Improvement; siRNA, small interfering ribonucleic acid.
- Leqvio® Summary of Product Characteristics.
- Ray KK et al. N Engl J Med 2020;[382(16):1507–1519.]
- Stoekenbroek RM et al. Future Cardiol 2018;14(6):433–442.
- Klinovski M et al. CADTH Issues in Emerging Health Technologies, 2019. Canadian Agency for Drugs and Technologies in Health.
- Gov.uk. New heart disease drug to be made available for NHS patients. Available at: https://www.gov.uk/government/news/new-heart-disease-drug-to-be-made-ava... [Accessed: January 2021].
- Raal FJ et al. N Engl J Med 2020;382(16):1520–1530.
- Ray KK et al. N Engl J Med 2020;382(16):1507–1519 (trial protocols).