Inclisiran

(Leqvio®)

Leqvio®

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Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 284 mg/1.5 mL)
Drug ClassSmall interfering RNAs (siRNAs)
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Summary
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  • Inclisiran (Leqvio) is used alongside a diet and statin therapy at the highest tolerated dose for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who need further reduction of low-density lipoprotein cholesterol.
  • A total of 14 systematic reviews/meta-analyses provided insights into Leqvio's efficacy and safety profile compared to drugs like evolocumab and alirocumab.
  • The medication demonstrates significant effectiveness in lowering LDL-C levels in various patient groups, particularly those with heterozygous familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease. One study showed a 50.7% reduction when administered twice yearly in addition to maximally tolerated statin therapy.
  • Compared to PCSK9 inhibitors such as evolocumab and alirocumab, inclisiran offers comparable reductions in LDL-C levels; however, its twice-yearly dosing regimen may improve compliance due to the less frequent administration required than monoclonal antibodies.
  • In terms of safety, inclisiran was generally well-tolerated, with adverse events similar to those reported in placebo groups. Injection-site reactions were more common but were predominantly mild and did not lead to discontinuation, while serious adverse events did not significantly differ from the placebo group nor increased risk compared to other PCSK9 inhibitors.
  • In specific groups such as patients at high risk of or existing ASCVD along with the HeFH population, it showed notable effectiveness by significantly reducing lipid parameters, emphasizing its potential for managing patients needing substantial LDL-C lowering beyond what can be achieved with statins alone.
  • Network meta-analyses indicate that inclisiran provides similar reductions in LDL-C when added to maximum tolerated statins like evolocumab and alirocumab, but its dosing regimen could offer advantages regarding adherence and patient preference.
  • Some studies suggested potential cardiovascular benefits with inclisiran associated with a reduction in major adverse cardiovascular events, aligning with the recognized benefits of lowering LDL-C levels on cardiovascular risk. However, more comprehensive and longer-term trials are necessary to conclusively determine the impact of inclisiran on events such as myocardial infarction, stroke, and cardiovascular mortality compared to other PCSK9 inhibitors and statins.

Product Monograph / Prescribing Information

Document TitleYearSource
Leqvio (inclisiran) Prescribing Information.2023Novartis Pharmaceuticals Corporation, East Hanover, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy of Inclisiran in patients having familial hypercholesterolemia: Heterozygous compared to homozygous trait, a systematic review and meta analysis.2024Critical Pathways in Cardiology
Serious adverse events of inclisiran in patients with hypercholesterolemia, a meta-analysis of ORION trials.2024Critical Pathways in Cardiology
A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients.2024Expert Opinion on Drug Safety
Efficacy and safety of inclisiran in stroke or cerebrovascular disease prevention: a systematic review and meta-analysis of randomized controlled trials.2023Frontiers in Pharmacology
Proprotein convertase subtilisn/kexin type 9 inhibitors and small interfering RNA therapy for cardiovascular risk reduction: a systematic review and meta-analysis.2023PloS One
The association between PCSK9 inhibitor use and sepsis: a systematic review and meta-analysis of 20 double-blind, randomized, placebo-controlled trials.2023The American Journal of Medicine
PCSK9 inhibitors for secondary prevention in patients with cardiovascular diseases: a Bayesian network meta-analysis.2022Cardiovascular Diabetology
Network meta-analysis of randomized trials evaluating the comparative efficacy of lipid-lowering therapies added to maximally tolerated statins for the reduction of low-density lipoprotein cholesterol. 2022Journal of the American Heart Association
The promising novel therapies for familial hypercholesterolemia.2022Journal of Clinical Laboratory Analysis
Comparative efficacy of non-statin lipid-lowering therapies in patients with hypercholesterolemia at increased cardiovascular risk: a network meta-analysis.2022Current Medical Research and Opinion
Efficacy and safety of inclisiran a newly approved FDA drug: a systematic review and pooled analysis of available clinical studies.2022American Heart Journal Plus: Cardiology Research and Practice
Pooled patient-level analysis of inclisiran trials in patients with familial hypercholesterolemia or atherosclerosis.2021Journal of the American College of Cardiology
Meta-analysis of clinical outcomes of PCSK9 modulators in patients with established ASCVD.2021Pharmacotherapy
A meta-analysis of cardiovascular outcomes in patients with hypercholesterolemia treated with inclisiran.2020The American Journal of Cardiology
Meta-analysis of inclisiran for the treatment of hypercholesterolemia.2020The American Journal of Cardiology

Clinical Practice Guidelines