East Region Formulary
NHS Scotland

Hypercholesterolaemia

ASSIGN CVD calculator SIGN 149: Cardiovascular disease NICE CG181: Cardiovascular disease

Primary prevention - cardiovascular disease

Statin treatment indicated for estimated 10year cardiovascular risk >20%.

Atorvastatin
Atorvastatin 20mg tablets

20mg to be taken in the morning.

Suitable for those intolerant to atorvastatin.

Rosuvastatin
Rosuvastatin 5mg tablets

Initially 5-10mg once daily, then increased up to 20mg once daily at intervals of at least four weeks. See BNF for further details.

Rosuvastatin 10mg tablets

Initially 5-10mg once daily, then increased up to 20mg once daily at intervals of at least four weeks. See BNF for further details.

Rosuvastatin 20mg tablets

Initially 5-10mg once daily, then increased up to 20mg once daily at intervals of at least four weeks. See BNF for further details.

Prescribing Notes:

  • See SIGN guideline 149 and NICE Clinical Guideline 181.
  • Lowering cholesterol is associated with reduced mortality and morbidity in patients at high and moderate risk of, or with established, cardiovascular and cerebrovascular disease.
  • Consider statin treatment for the primary prevention of CVD in all adults with type 1 diabetes; and offer statin treatment for primary prevention of CVD to adults with type 1 diabetes who are aged >40 or have had diabetes for >10 years or have established nephropathy or have other CVD risk factors.
  • Offer statin treatment for primary prevention of CVD to people with type 2 diabetes who have a 10% or greater risk of developing CVD.
  • Consult renal physician if renal function is eGFR<30ml/min
  • Chewable atorvastatin tablets can be prescribed for those patients with swallowing difficulties.
  • Fibrates have been less well tested in clinical trials. They are mainly of benefit in those with mixed hyperlipidaemia and low HDL cholesterol.
  • Caution should be exercised when prescribing other drugs with statins. See BNF for full details of drug interactions.
  • The MHRA has produced recommendations for dose restrictions when used with some other drugs as interactions may increase the risk of adverse effects, or reduce the effectiveness of statin treatment.

History Notes

03/05/2023

Prescribing notes updated, ERWG May 23.

16/02/2022

East Region Formulary content agreed.

Treatment with human monoclonal antibodies
Alirocumab
Alirocumab 75mg/1ml solution for injection pre-filled disposable devices

As per specialist.

Alirocumab 150mg/1ml solution for injection pre-filled disposable devices

As per specialist.

Evolocumab
Repatha SureClick 140mg/1ml solution for injection pre-filled pens

As per specialist.

Prescribing Notes:

  • Evolocumab is approved for specialist initiation for adults with primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach low density lipoprotein-cholesterol (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.

History Notes

16/02/2022

East Region Formulary content agreed.

Treatment with adenosine triphosphate citrate lyase inhibitors
Bempedoic acid
Nilemdo 180mg tablets

As per specialist.

Bempedoic acid + Ezetimibe
Nustendi 180mg/10mg tablets

As per specialist.

Prescribing Notes:

  • SMC accepted bempedoic acid (Nilemdo) for restricted use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet. SMC restriction – for use in combination with ezetimibe in patients who are: statin intolerant or for whom a statin is contra-indicated; and where ezetimibe alone does not appropriately control LDL-C; and where proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors are not appropriate.
  • SMC accepted bempedoic acid + ezetimibe (Nustendi) for restricted use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet. SMC restriction - for use in patients who are: statin intolerant or for whom a statin is contra-indicated; statin intolerant or for whom a statin is contra-indicated; where proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors are not appropriate.

History Notes

16/02/2022

East Region Formulary content agreed.

Treatment with small interfering ribonucleic acid (siRNA)

An alternative to evolocumab or alirocumab (PCSK9i monoclonal antibody therapies) where these treatments are either not tolerated or insufficiently effective.

Inclisiran
Inclisiran 284mg/1.5ml solution for injection pre-filled syringes

Initially, by subcutaneous injection, 284mg for 1 dose, followed by 284mg after 3 months for 1 dose, then 284mg every 6 months.

Prescribing Notes:

  • Inclisiran is approved for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
    • in combination with a statin or statin with other lipid lowering therapies in patients who are 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.
  • SMC restricts inclisiran for specialist use only in patients at high cardiovascular risk as follows:
    • patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C ≥5.0mmol/L, for primary prevention of cardiovascular events or,
    • patients with HeFH and LDL-C≥3.5mmol/L, for secondary prevention of cardiovascular events or,
    • patients with high risk due to previous cardiovascular events and LDL-C≥4.0mmol/L or,
    • patients with recurrent/polyvascular disease and LDL-C≥3.5mmol/L.

History Notes

08/02/2023

Addition of Inclisiran SMC2358 ERFC Sept 2022.

Treatment of hypercholesterolaemia
Pravastatin
Pravastatin 10mg tablets

For dose, refer to BNF for Children.

Pravastatin 20mg tablets

For dose, refer to BNF for Children.

Pravastatin 40mg tablets

For dose, refer to BNF for Children.

Atorvastatin
Atorvastatin 10mg tablets

For dose, refer to BNF for Children.

Atorvastatin 20mg tablets

For dose, refer to BNF for Children.

Atorvastatin 20mg chewable tablets sugar free

For dose, refer to BNF for Children.

Atorvastatin 40mg tablets

For dose, refer to BNF for Children.

Atorvastatin 80mg tablets

For dose, refer to BNF for Children.

Rosuvastatin
Rosuvastatin 5mg tablets

For dose, refer to BNF for Children.

Rosuvastatin 10mg tablets

For dose, refer to BNF for Children.

Rosuvastatin 20mg tablets

For dose, refer to BNF for Children.

Prescribing Notes:

  • Lowering cholesterol is associated with reduced mortality and morbidity in patients at high and moderate risk of, or with established, cardiovascular and cerebrovascular disease. In childhood, the major indication is in patients who have had a cardiac transplant.

History Notes

19/06/2023

East Region Formulary content agreed - ERFC 07/06/2023.