. 2022 Mar 17;18(3):569–576. doi: 10.5114/aoms/147435

Table I.

Summary of available recommendations/approvals for inclisiran administration in lipid disorder patients

Institution/Society (date of public release)	European Medicines Agency (EMA) (Dec. 9^th 2020) [23]	PoLA/CFPiP/PCS/PSLD/PSD/PSH guidelines on diagnosis and therapy of lipid disorders in Poland 2021 (Sept. 4^th 2021) [15]	The National Institute for Health and Care Excellence (NICE) (Oct. 6^th 2021) [25]	US Food and Drug Administration (FDA) (Dec. 22^nd 2021) [24]
Indications for inclisiran administration in patients with lipid disorders	Inclisiran is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet: In combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated	Recommendations on the use of inclisiran: In patients with ASCVD and/or FH who do not achieve the target at the maximum tolerated dose of a statin and ezetimibe, initiation of inclisiran may be considered (IIbB) If a statin-based regimen is not tolerated at any dose (even after rechallenge), treatment with inclisiran may be considered (IIbC) In primary or secondary prevention in very high-risk patients who are non-adherent to lipid-lowering therapy or who are not willing to use statin therapy, treatment with inclisiran may be considered (IIbC)	Inclisiran is recommended as an option for treating primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia as an adjunct to diet in adults. It is recommended only if: There is a history of any of the following cardiovascular events: – Acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalization) – Coronary or other arterial revascularization procedures – Coronary heart disease – Ischemic stroke or – Peripheral arterial disease AND Low-density lipoprotein cholesterol (LDL-C) concentrations are persistently 2.6 mmol/l or more, despite maximum tolerated lipid-lowering therapy, that is: – Maximum tolerated statins with or without other lipid-lowering therapies or – Other lipid-lowering therapies when statins are not tolerated or are contraindicated	Inclisiran injection was approved as a treatment to be used along with diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C)

Institution/Society (date of public release)

European Medicines Agency (EMA) (Dec. 9^th 2020) [23]

PoLA/CFPiP/PCS/PSLD/PSD/PSH guidelines on diagnosis and therapy of lipid disorders in Poland 2021 (Sept. 4^th 2021) [15]

The National Institute for Health and Care Excellence (NICE) (Oct. 6^th 2021) [25]

US Food and Drug Administration (FDA) (Dec. 22^nd 2021) [24]

Indications for inclisiran administration in patients with lipid disorders

Inclisiran is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:

In combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated

Recommendations on the use of inclisiran:

In patients with ASCVD and/or FH who do not achieve the target at the maximum tolerated dose of a statin and ezetimibe, initiation of inclisiran may be considered (IIbB)
If a statin-based regimen is not tolerated at any dose (even after rechallenge), treatment with inclisiran may be considered (IIbC)
In primary or secondary prevention in very high-risk patients who are non-adherent to lipid-lowering therapy or who are not willing to use statin therapy, treatment with inclisiran may be considered (IIbC)

Inclisiran is recommended as an option for treating primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia as an adjunct to diet in adults. It is recommended only if:

There is a history of any of the following cardiovascular events:
- – Acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalization)
- – Coronary or other arterial revascularization procedures
- – Coronary heart disease
- – Ischemic stroke or
- – Peripheral arterial disease

AND

Low-density lipoprotein cholesterol (LDL-C) concentrations are persistently 2.6 mmol/l or more, despite maximum tolerated lipid-lowering therapy, that is:
- – Maximum tolerated statins with or without other lipid-lowering therapies or
- – Other lipid-lowering therapies when statins are not tolerated or are contraindicated

Inclisiran injection was approved as a treatment to be used along with diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C)