Drug updated on 12/11/2024
Dosage Form | Injection (subcutaneous; 284 mg/1.5 mL [189 mg/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
- This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
- Inclisiran significantly reduced Low-Density Lipoprotein (LDL)-C (major adverse cardiovascular events (MACE)) levels by -45.48% (95% confidence interval (CI) (95% CI: -51.75, -41.13, p<0.01): -50.36%, -40.61%) compared to placebo, with additional reductions in total cholesterol, non-high-density lipoprotein (HDL) (mean difference (MD) = -39.45%, 95% CI: -43.6%, -35.31%) cholesterol, and apolipoprotein B levels. It also increased HDL-C levels significantly.
- In patients with heterozygous familial hypercholesterolemia (HeFH), inclisiran reduced LDL-C by -48.62%, while in homozygous familial hypercholesterolemia (HoFH), the reduction was -9.12%, showing greater effectiveness in heterozygous familial hypercholesterolemia (HeFH) patients (P < 0.05).
- Comparatively, inclisiran was slightly less effective than evolocumab, which reduced LDL-C by -61.09%, but it showed similar effectiveness to alirocumab (-46.35%).
- Inclisiran demonstrated effectiveness in reducing major adverse cardiac events (MACE), with a significant reduction compared to placebo (relative risk (RR) (0.98,1.12) = 0.79, p = 0.05), making it beneficial for patients with cardiovascular disease.
- Inclisiran was associated with a non-significant elevated risk of total adverse events (RR = 1.05, p = 0.16) and non-serious adverse events (RR = 1.09, p = 0.15) compared to placebo, while the risk of serious adverse events was lower (RR = 0.94, p = 0.67).
- There was a significantly increased risk of injection-site reactions with inclisiran, including any reaction (odds ratio (OR) (95% CI: 0.64, 0.81, p<0.01) = 5.86), mild reactions (OR = 5.19), and moderate reactions (OR = 13.37), while there was also an elevated risk of bronchitis (OR = 1.58).
- Liver and kidney function tests, creatine kinase values, and platelet counts showed no significant differences between inclisiran and placebo.
- Inclisiran significantly reduced LDL-C and other lipid parameters in patients with HeFH and homozygous familial hypercholesterolemia (HoFH), with a greater reduction in HeFH patients for LDL-C (-48.62% in HeFH vs. -9.12% in HoFH, P < 0.05). It also significantly reduced LDL-C in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk equivalents, showing consistent effectiveness 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 |
---|---|---|
Inclisiran: A New Strategy for LDL-C Lowering and Prevention of Atherosclerotic Cardiovascular Disease. | 2023 | Vascular Health and Risk Management |
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 |