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Review
. 2025 Jan 9;27(1):25.
doi: 10.1007/s11883-024-01271-x.

Inclisiran, Reasons for a Novel Agent in a Crowded Therapeutic Field

Francesco Di Giacomo-Barbagallo  1   2 , Natalia Andreychuk  1 , Roberto Scicali  2 , Ana Gonzalez-Lleó  1 , Salvatore Piro  2 , Lluis Masana  3   4 , Daiana Ibarretxe  1
Affiliations
Review

Inclisiran, Reasons for a Novel Agent in a Crowded Therapeutic Field

Francesco Di Giacomo-Barbagallo et al. Curr Atheroscler Rep. .

Abstract

Purpose of the review: A significant number of patients fail to achieve target LDL cholesterol (LDL-C) levels. This review aims to explore why inclisiran, a novel class of LLT, should be considered a valuable addition to the current treatment options.

Recent findings: Inclisiran is a small interfering RNA (siRNA) that targets PCSK9 synthesis specifically in the hepatocytes. The drug remains in circulation for less than 48 h, but its effect lasts for over six months. Two subcutaneous injections per year consistently lowers LDL-C by approximately 55% with a favorable safety profile. In combination with other LLTs, it can achieve LDL-C reductions of over 80%, supporting its role in high-intensity LLT strategies. Inclisiran represents a novel class of LLT. Administered biannually, reduces baseline LDL-C levels by half. Additionally, it has a strong safety profile. Due to its pharmacokinetic properties, is likely to improve adherence to LLT and persistently maintain low LDL-C levels.

Keywords: Cardiovascular prevention; Inclisiran; LDLcholesterol; Lipid lowering therapy; PCSK9 targeted therapies.

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Conflict of interest statement

Declarations. Conflict of Interest: FDGB, RS, SP and NA have nothing to declare. AGL has received fees for lectures or support to attending meeting from Sanofi, Ferrer, Novartis. DI receives fees for lectures from Novartis, Sanofi, Chiesi, Novartis, SOBI, Daiichi-Sankyo LM receives fees for lectures and advisory work from Chiesi, Novartis, Sanofi, Amarin, MSD, Daiichi-Sankio, Ultragenix, out of this work. Human and Animal Rights and Informed Consent: This article does not contain any studies with human or animal subjects performed by any of the authors.

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