Drug updated on 9/9/2024
Dosage Form | Injection (subcutaneous; 284 mg/1.5 mL) |
Drug Class | Small interfering RNAs (siRNAs) |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce lowdensity lipoprotein cholesterol (LDL-C).
Latest News
Summary
- Leqvio (inclisiran) is 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).
- This summary is based on the review of 14 systematic review(s)/meta-analysis(es). [1-15]
- Reduction in LDL-C Levels: Inclisiran led to a 51% reduction in LDL-C compared to placebo. Reductions varied by familial hypercholesterolemia type: 48.62% in HeFH and 9.12% in HoFH.
- Cardiovascular Events: Inclisiran was associated with a 32% reduction in myocardial infarction risk and a 24% lower rate of major adverse cardiovascular events.
- Comparison with Other Lipid-Lowering Agents: Inclisiran provided comparable LDL-C reduction to evolocumab and alirocumab, although evolocumab and alirocumab had higher efficacy in some lipid parameters.
- Efficacy Across Different Populations: Inclisiran was effective in reducing LDL-C in patients with ASCVD, HeFH, and those at high cardiovascular risk when added to maximally tolerated statins.
- Serious Adverse Events (SAEs): Inclisiran did not show a significant incidence of serious adverse events, with pooled estimates indicating no significant differences in SAEs following inclisiran administration.
- Injection-Site Reactions: Inclisiran was associated with increased injection-site reactions, which were predominantly mild or moderate, and more frequent compared to placebo.
- Other Adverse Effects: Inclisiran was associated with higher odds ratios for product issues and endocrine disorders, with bronchitis noted as another adverse effect. No significant differences were observed in liver and kidney function tests, creatine kinase values, and platelet counts between inclisiran and placebo groups.
- Inclisiran was also effective in patients with ASCVD, ASCVD risk equivalents, and statin-intolerant individuals, demonstrating significant reductions in LDL-C and other lipid parameters across these populations.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Leqvio (inclisiran) Prescribing Information. | 2024 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee. | 2022 | Journal of the American College of Cardiology |