Inclisiran: A New Strategy for LDL-C Lowering and Prevention of Atherosclerotic Cardiovascular Disease
Open accessAbstract
Multiple lines of evidence confirm that the cumulative burden of low-density lipoprotein cholesterol (LDL-C) is causally related to the development of atherosclerotic cardiovascular disease (ASCVD). As such, lowering LDL-C is a central tenet in all ASCVD prevention guidelines, which recommend matching the intensity of LDL-C lowering with the absolute risk of the patient. Unfortunately, issues such as difficulty with long-term adherence to statin therapy and inability to achieve desired LDL-C thresholds with statins alone results in residual elevated ASCVD risk. Non-statin therapies generally provide similar risk reduction per mmol/L of LDL-C reduction and are included by major society guidelines as part of the treatment algorithm for managing LDL-C. Per the 2022 American College of Cardiology Expert Consensus Decision Pathway, patients with ASCVD are recommended to achieve both an LDL-C reduction ≥50% and an LDL-C threshold of <55 mg/dL in patients at very high-risk and <70 mg/dL in those not at very high risk. Patients with familial hypercholesterolemia (FH) but without ASCVD should lower LDL-C to <100 mg/dL. For patients who remain above LDL-C thresholds with maximally tolerated statin therapy plus lifestyle changes, non-statin therapy warrants strong consideration. While several non-statin therapies have been granted FDA approval for managing hypercholesterolemia (eg, ezetimibe, Proprotein Convertase Subtilisin/Kexin 9 [PCSK9] monoclonal antibodies, and bempedoic acid), the focus of the current review is on inclisiran, a novel small interfering RNA therapy that inhibits the production of the PCSK9 protein. Inclisiran is currently FDA approved as an adjunct to statin therapy in patients with clinical ASCVD or heterozygous FH who require additional LDL-lowering. The drug is administered by subcutaneous injection twice a year, after an initial baseline and 3 month dose. In this review, we sought to provide an overview of the use of inclisiran, review current trial data, and outline an approach to potential patient selection.
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Inclisiran has been approved by the U.S. Food and Drug Administration as an adjunct to diet and maximally tolerated statin therapy in adults with hypercholesterolemia.
“has been approved by the U.S. Food and Drug Administration as an adjunct to diet and maximally tolerated statin therapy in adults with hypercholesterolemia.3”
From Small Interfering RNA for LDL-Cholesterol Reduction (2026) · cites this paper as [3]
The Approach to Patient Selection section confirms FDA approval as an adjunct to diet and maximally tolerated statin therapy. It limits that approval to adults with heterozygous familial hypercholesterolemia (HeFH) or ASCVD who require further LDL-C lowering; the claim's broader phrase “adults with hypercholesterolemia” omits those restrictions. No page number is supplied for the passage. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe 50-60 mg/dL reduction in LDL-C from inclisiran administration indicates that patients may experience a 25-30% relative risk reduction in ASCVD events comparable to what PCSK9 monoclonal antibodies provide.
“The 50–60 mg/dL reduction in LDL-C from inclisiran administration indicates that patients may experience a 25–30% relative risk reduction in ASCVD events comparable to what PCSK9 monoclonal antibodies provide [26].”
From Inclisiran SiRNA therapy for durable LDL-C reduction: a systematic review and meta-analysis highlighting a breakthrough in long-term cardiovascular risk management (2026) · cites this paper as [26]
The Clinical Efficacy and Safety section reports roughly 50% LDL-C lowering with inclisiran, and Cardiovascular Outcomes Data reports a preliminary pooled analysis with a MACE hazard ratio of 0.75. But the Introduction reports a 15% relative risk reduction for each PCSK9 monoclonal antibody—not 25–30%—and the Conclusion says dedicated cardiovascular outcomes results for inclisiran were not yet available. The claimed 50–60 mg/dL reduction and comparable 25–30% event-risk reduction are therefore not established by this review. (LLM, conf=0.88)
Experimental — accuracy not yet measuredInclisiran is a synthetic small interfering RNA that targets hepatic production of proprotein convertase subtilisin/kexin type 9.
“Inclisiran is a synthetic small interfering RNA (siRNA) that targets hepatic production of proprotein convertase subtilisin/kexin type 9 (PCSK9)”
From Small Interfering RNA for LDL-Cholesterol Reduction (2026) · cites this paper as [3]
Inclisiran has a twice-yearly dosing schedule.
“Its twice-yearly dosing offers a unique therapeutic approach”
From Small Interfering RNA for LDL-Cholesterol Reduction (2026) · cites this paper as [3]
Inclisiran leads to increased LDL receptor expression.
“leading to increased LDL receptor expression”
From Small Interfering RNA for LDL-Cholesterol Reduction (2026) · cites this paper as [3]
Inclisiran produces substantial LDL-C reduction.
“and substantial LDL-C reduction.”
From Small Interfering RNA for LDL-Cholesterol Reduction (2026) · cites this paper as [3]
Clinical trials demonstrate that LDL-C levels decrease by 50% and maintain this reduction for at least 18 months of treatment.
“Clinical trials demonstrate that LDL-C levels decrease by 50% and maintain this reduction for at least 18 months of treatment [25, 26].”
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“The 50–60 mg/dL reduction in LDL-C from inclisiran administration indicates that patients may experience a 25–30% relative risk reduction in ASCVD events comparable to what PCSK9 monoclonal antibodies provide [26].”
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- Authors
- Albosta, M. S., Grant, J. K., Taub, P., Blumenthal, R. S., Martin, S. S., & Michos, E. D.
- Affiliations
- University of Miami (US)
- Johns Hopkins University (US)
- University of California San Diego (US)
- Corresponding author
- Michos, Erin D
- Venue
- Vascular Health and Risk Management
- Publisher
- Informa UK Limited
- Published
- 2023-07
- Volume
- Volume 19
- Pages
- 421-431
- ISSN
- 1176-6344 (ISSN-L)
- 1178-2048
- PMC
- PMC10332363
- OpenAlex
- W4383342581
- Cited by
- 51
- References
- 44
- Citations by year
- 2026: 15 · 2025: 19 · 2024: 16 · 2023: 1
- FWCI
- 3.30
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Vascular Health and Risk Management (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- inclisiran, LDL cholesterol lowering, atherosclerotic cardiovascular disease prevention, PCSK9 inhibition, non-statin therapy, statin therapy, familial hypercholesterolemia, heterozygous familial hypercholesterolemia, hypercholesterolemia, LDL-C thresholds, patient selection
- MeSH terms
- Proprotein Convertase 9, Cardiovascular Diseases, Humans, Hyperlipoproteinemia Type II, Cholesterol, LDL, RNA, Small Interfering, Atherosclerosis
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