2.12. Lipid-modifying drugs
See the NHSGGC Guidelines for the Management of Cholesterol, available on the Clinical Guidelines Directory on StaffNet.
Prescribing Notes:
For guidance on the management of cholesterol for primary and secondary prevention of coronary heart disease and stroke, see the NHSGGC Cholesterol Guidelines.
Excludes chewable tablets.
Prescribing Notes:
- The MHRA has issued updated advice on prescribing simvastatin based on information relating to the risk of myopathy and rhabdomyolysis. The changes include some additional medicines with which simvastatin is contraindicated and advice on a maximum recommended dose when simvastatin is taken with other medicines.
- PostScript 71 offers further advice on how to manage patients prescribed simvastatin and these other interacting medicines
- Caution in renal impairment (see BNF for details).
Restrictions:
Restricted to use only on the advice of a lipid specialist in accordance with local protocol (click here) and implementation plan only in patients with:
- heterozygous familial hypercholesterolaemia (HeFH) and LDL-C ≥5.0mmol/L as primary prevention of cardiovascular events
- or patients with HeFH and LDL-C ≥3.5mmol/L as secondary prevention of cardiovascular event.
Prescribing Notes:
- Use in other patient groups is subject to ongoing discussion. All requests for this medicine are to come from lipid clinics.
- A summary of key prescribing information for GPs can be found here.
- Wider licensed use of the medicine may not be accepted for use by SMC. See SMC advice for details.
Restrictions:
Restricted to use only on the advice of a lipid specialist in accordance with local guidelines for adults
with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as
an adjunct to diet:
- 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
Restrictions:
Restricted to use only on the advice of a lipid specialist in accordance with local guidelines for adults
with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as
an adjunct to diet:
- 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
Restrictions:
Restricted to use only on the advice of a lipid specialist in accordance with local protocol (click here) and implementation plan only:
- in patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C ≥5.0 mmol/L for primary prevention of cardiovascular events
- in patients with HeFH and LDL-C ≥3.5 mmol/L for secondary prevention of cardiovascular events
Evolocumab is only Formulary when administered at a dose of 140mg every two weeks (i.e. excludes 420mg once monthly dosing).
Prescribing Notes:
Use in other patient groups is subject to ongoing discussion. All requests for this medicine are to come from lipid clinics.
A summary of key prescribing information for GPs can be found here
Restrictions:
Secondary prevention of coronary heart disease and stroke
- In combination with a statin where the goals of treatment are not met on the maximal tolerated dose of statin, in accordance with the NHSGGC Cholesterol Guidelines .
- As monotherapy restricted to patients who are statin intolerant and in accordance to the NHSGGC Cholesterol Guideline (in development). This use is off-label.
Prescribing Notes:
- Use of ezetimibe for primary prevention remains non-Formulary.
- Use in combination with bempedoic acid to follow local guideline (in development).
Restrictions:
Restricted to specialist initiation, monitoring and assessment of response for secondary prevention in patients treated with a stable dose of statins, low-density lipoprotein (LDL) cholesterol levels >1.04mmol/L and ≤2.60mmol/L, raised fasting triglycerides (≥1.7mmol/L) and with established cardiovascular disease defined as a history of any of the following:
- Acute coronary syndrome (ACS) (such as MI or unstable angina needing hospitalisation)
- Coronary or other arterial revascularisation procedures
- Coronary heart disease
- Ischaemic stroke
- Peripheral arterial disease
Restrictions:
Restricted to use only on the advice of a lipid specialist in accordance with local guidelines for adults
with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as
an adjunct to diet 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
Restrictions:
Restricted to use only in patients in whom drug interactions might pose a problem or for patients who are intolerant of simvastatin and atorvastatin. See the NHSGGC Cholesterol Guidelines.
Restrictions:
Restricted to use only in patients who fail to reach target lipid levels in accordance with the NHSGGC Cholesterol Guidelines or are intolerant of other statins. Doses of 40mg or higher should only be initiated by, or on the advice of a specialist. The use for primary prevention is not recommended by SMC and is non-Formulary.
Restrictions:
Restricted to specialist use as an adjunct to diet in adult patients with genetically confirmed familial chylomicronaemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
Prescribing Notes:
- This therapy is available via the Scottish Government Ultra-orphan pathway
- Formulary status will be reconsidered following the reassessment by SMC (expected November 2023).