Article ; Online: An update on inclisiran for the treatment of elevated LDL cholesterol.
Expert opinion on pharmacotherapy
2024 Volume 25, Issue 4, Page(s) 349–358
Abstract: Introduction: The burden of atherosclerotic cardiovascular disease (ASCVD) persists globally, demanding innovative therapeutic strategies. This manuscript provides an expert opinion on the significance of managing low-density lipoprotein cholesterol in ... ...
Abstract | Introduction: The burden of atherosclerotic cardiovascular disease (ASCVD) persists globally, demanding innovative therapeutic strategies. This manuscript provides an expert opinion on the significance of managing low-density lipoprotein cholesterol in ASCVD prevention and introduces inclisiran, a novel small interfering RNA targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). Areas covered: This work delves into the intricate mechanism of inclisiran, highlighting its unique approach of hepatic intracellular PCSK9 inhibition, its precision and low off-target effects risk. Pharmacodynamic and pharmacokinetic distinctions from PCSK9 monoclonal antibodies are explored, underlining inclisiran's efficiency, extended duration, and clearance. Clinical trials, including pivotal phase-III placebo-controlled studies (ORION-9, -10, -11), the open-label ORION-3 and pooled safety analysis of these trails including the open-label phase of ORION-8, as well as real-word data are discussed to provide a comprehensive evaluation of inclisiran's efficacy and safety. Expert opinion: Inclisiran stands as a first-in-class breakthrough in lipid-lowering therapies, showing potential in alleviating the global burden of ASCVD and is supported by multiple global regulatory approvals. To optimize inclisiran's utilization and comprehend its long-term effects, future directions include pediatric studies, cardiovascular outcome trials, and extended-duration investigations. Overall, inclisiran emerges as a precise and effective therapeutic option, offering significant promise for preserving cardiovascular health. |
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MeSH term(s) | Humans ; Cholesterol, LDL/blood ; RNA, Small Interfering/therapeutic use ; PCSK9 Inhibitors ; Atherosclerosis/drug therapy ; Animals ; Proprotein Convertase 9/metabolism ; Anticholesteremic Agents/therapeutic use ; Anticholesteremic Agents/adverse effects ; Anticholesteremic Agents/pharmacology ; Cardiovascular Diseases/prevention & control ; Cardiovascular Diseases/drug therapy ; Hypercholesterolemia/drug therapy |
Chemical Substances | Cholesterol, LDL ; RNA, Small Interfering ; PCSK9 protein, human (EC 3.4.21.-) ; PCSK9 Inhibitors ; Proprotein Convertase 9 (EC 3.4.21.-) ; Anticholesteremic Agents ; ALN-PCS |
Language | English |
Publishing date | 2024-04-08 |
Publishing country | England |
Document type | Journal Article ; Review |
ZDB-ID | 2001535-5 |
ISSN | 1744-7666 ; 1465-6566 |
ISSN (online) | 1744-7666 |
ISSN | 1465-6566 |
DOI | 10.1080/14656566.2024.2337253 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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