Leqvio® [1]
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Leqvio® [2]
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
Leqvio® is the first FDA-approved small interfering RNA (siRNA) indicated for lowering LDL-C1,3,4
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Leqvio® delivered effective and sustained LDL-C reduction, in combination with a maximally tolerated statin, in patients with ASCVD (or risk equivalents)‡§2
Leqvio® 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 Leqvio® group2,5
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Leqvio® is not reimbursed in Ireland at this time.
‡ At Month 17, Leqvio® 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. 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
ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; FH, familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol; NICE, National Institute for Health and Care Excellence; siRNA, small interfering ribonucleic acid.
References
- Leqvio® Summary of Product Characteristics. Accessed August 2022 at www.ema.europe.eu [5]
- 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.
- Ray KK et al. N Engl J Med 2020;382(16):1507–1519 (trial protocols).