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NICE guidance - PCSK9 inhibitors

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

Alirocumab is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if:

  • low-density lipoprotein concentrations are persistently above the thresholds specified in table despite maximal tolerated lipid-lowering therapy. That is, either the maximum dose has been reached or further titration is limited by intolerance

Evolocumab is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if:

  • the dosage is 140 mg every 2 weeks
  • low-density lipoprotein concentrations are persistently above the thresholds specified in table despite maximal tolerated lipid-lowering therapy. That is, either the maximum dose has been reached, or further titration is limited by intolerance.

Low-density lipoprotein cholesterol concentrations above which alirocumab and evolocumab is recommended

Without CVD

CVD - High risk of CVD1

CVD - Very High risk of CVD2

Primary non-familial hypercholesterolaemia or mixed dyslipidaemia

Not recommended at any LDL-C concentration

Recommended only if LDL-C concentration is persistently above 4.0 mmol/l

Recommended only if LDL-C concentration is persistently above 3.5 mmol/l

Primary heterozygous-familial hypercholesterolaemia

Recommended only if LDL-C concentration is persistently above 5.0 mmol/l

Recommended only if LDL-C concentration is persistently above 3.5 mmol/l

Recommended only if LDL-C concentration is persistently above 3.5 mmol/l

1 - High risk of cardiovascular disease is defined as a history of any of the following: acute coronary syndrome (such as myocardial infarction or unstable angina requiring hospitalisation), coronary or other arterial revascularisation procedures, chronic heart disease, ischaemic stroke, peripheral arterial disease.

2 - Very high risk of cardiovascular disease is defined as recurrent cardiovascular events or cardiovascular events in more than 1 vascular bed (that is, polyvascular disease).

Abbreviations: CVD, cardiovascular disease; LDL-C, low-density lipoprotein cholesterol.

Reference:

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