NICE guidance - PCSK9 inhibitors
Last reviewed 01/2018
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.
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