Drug updated on 5/6/2024
| 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 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
- Inclisiran (Leqvio) is a drug 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).
- According to one systematic review, inclisiran was found effective in reducing myocardial infarction risk by 32% but did not significantly reduce stroke and major cardiovascular events risk in patients with ASCVD or those at high risk of ASCVD.
- A meta-analysis suggests that while both PCSK9 monoclonal antibody and inclisiran enable patients to achieve recommended LDL-C target, alirocumab might provide optimal benefits regarding all-cause mortality with relatively lower serious adverse event risks compared to evolocumab which may offer optimal benefits regarding myocardial infarction prevention.
- Another study showed that when added to maximally tolerated statins, nonstatin regimens like evolocumab and alirocumab were consistently more efficacious than inclisiran in lowering LDL-C levels among patients at elevated cardiovascular risk due insufficient reduction from appropriate doses of statin therapy alone.
- Seven Systematic Reviews / Meta-Analyses were reviewed overall providing insights into the comparative efficacy between drugs where no head-to-head trials exist suggesting similar clinically meaningful improvements in LDL-C levels among hypercholesterolemic patients on maximum-tolerated statins who are also at increased cardiovascular risk using either inclisiran, alirocumab or evolocumab.
- Despite frequent mild injection-site reactions associated with its use according pooled safety data from three phase 3 studies involving 3660 participants; twice-yearly administration of Inclisiran has been shown safe, well-tolerated and effective in lowering LDL-C levels among adults with heterozygous familial hypercholesterolemia, ASCVD or ASCVD risk equivalents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Leqvio (inclisiran) Prescribing Information. | 2023 | 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 |