Guidance

Recommendations

Recommendations

People have the right to be involved in discussions and make informed decisions about their care, as described in NICE's information on making decisions about your care.

Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

1.1 Identifying and assessing cardiovascular disease risk for people without established cardiovascular disease

Identifying people for full formal risk assessment

1.1.1

For the primary prevention of cardiovascular disease (CVD) in primary care, use a systematic strategy to identify people who are likely to be at high risk of CVD. [2008, amended 2014]

1.1.2

Prioritise people based on an estimate of their CVD risk before doing a full formal risk assessment. Estimate their CVD risk using CVD risk factors already recorded in primary care electronic medical records. [2008]

1.1.3

Review estimates of CVD risk on an ongoing basis for people over 40. [2008]

1.1.4

Prioritise people for a full formal risk assessment if their estimated 10‑year risk of CVD is 10% or more. [2008, amended 2014]

1.1.5

Discuss the process of risk assessment with the person identified as being at risk, including the option of declining any formal risk assessment. [2008]

1.1.6

Do not use opportunistic assessment as the main strategy in primary care to identify CVD risk in unselected people. [2008]

Full formal risk assessment

1.1.7

Use the QRISK3 tool to calculate the estimated CVD risk within the next 10 years for people aged between 25 and 84 without CVD. [May 2023]

1.1.8

Use the QRISK3 tool for people with type 2 diabetes aged between 25 and 84. [May 2023]

Until electronic clinical systems in which QRISK2 is embedded are updated with QRISK3, it may be necessary to use QRISK2.

When assessing risk for people taking corticosteroids or atypical antipsychotics or people with systemic lupus erythematosus, migraine, severe mental illness or erectile dysfunction, use QRISK3 (the online version of QRISK3, if necessary) because QRISK2 does not take these risk factors into account and may underestimate the 10‑year CVD risk in these populations.

1.1.9

Do not use a risk assessment tool for people who are at high risk of CVD, including people with:

1.1.10

Recognise that CVD risk tools may underestimate risk in certain groups of people, including but not limited to:

  • people treated for HIV

  • people already taking medicines to treat CVD risk factors

  • people who have recently stopped smoking

  • people taking medicines that can cause dyslipidaemia, such as immunosuppressant drugs

  • people with severe mental illness

  • people with autoimmune disorders, and other systemic inflammatory disorders. [May 2023]

1.1.11

Consider people aged 85 or older to be at increased risk of CVD because of age alone, particularly people who smoke or have raised blood pressure. [May 2023]

For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on full formal risk assessment.

Full details of the evidence and the committee's discussion are in evidence review A: CVD risk assessment tools: primary prevention.

Communication about risk assessment, lifestyle changes and treatment

1.1.13

Set aside adequate time during the consultation to provide information on risk assessment and to answer any questions. Arrange for further consultation if needed. [2008, amended May 2023]

1.1.14

Document the discussion relating to the consultation on risk assessment and the person's decision. [2008]

1.1.15

Offer people information about their absolute risk of CVD and the absolute benefits and harms of any intervention over a 10‑year period. [2008]

1.1.16

Consider using a lifetime risk tool such as QRISK3-lifetime to inform discussions on CVD risk and to motivate lifestyle changes, particularly for people with a 10‑year QRISK3 score less than 10%, and people under 40 who have CVD risk factors. [May 2023]

1.1.17

To encourage the person to participate in reducing their CVD risk:

  • find out what, if anything, the person has already been told about their CVD risk and how they feel about it

  • explore the person's beliefs about what determines future health (this may affect their attitude to changing risk)

  • assess their readiness to make changes to their lifestyle (diet, physical activity, smoking and alcohol consumption), to undergo investigations and to take long-term medication

  • assess their confidence to make changes to their lifestyle, undergo investigations and take medication

  • inform them of potential future management options based on current evidence and best practice

  • involve them in developing a shared management plan

  • check that they have understood what has been discussed. [2008, amended 2014]

1.1.18

If the person's CVD risk is at a level where treatment is recommended but they decline the offer of treatment, advise them that their CVD risk should be reassessed in the future. Record their choice in their medical records. [2008, amended 2014]

For a short explanation of why the committee made the 2023 recommendation and how it might affect practice, see the rationale and impact section on communication about risk assessment, lifestyle changes and treatment.

Full details of the evidence and the committee's discussion are in evidence review A: CVD risk assessment tools: primary prevention.

1.2 Aspirin for primary prevention of cardiovascular disease

NICE's surveillance team reviewed the evidence about aspirin for the primary prevention of CVD. Based on the review, NICE decided to add a do not routinely offer recommendation about this. For full details, see the January 2023 exceptional surveillance report.

1.3 Lifestyle changes for the primary and secondary prevention of cardiovascular disease

Behaviour change

Healthy eating

For advice on healthy eating, see the NHS eat well guide.

Cardioprotective diet

1.3.2

Advise people at high risk of or with CVD to eat a diet in which total fat intake is 30% or less of total energy intake, saturated fats are 7% or less of total energy intake, and where possible saturated fats are replaced by mono‑unsaturated and polyunsaturated fats. [May 2023]

1.3.3

Advise people at high risk of or with CVD to:

  • reduce their saturated fat intake

  • increase their mono-unsaturated fat intake with olive oil, rapeseed oil or spreads based on these oils and to use them in food preparation. [2014]

1.3.4

Take account of a person's individual circumstances, for example, drug treatment, comorbidities and other lifestyle changes, when giving dietary advice. [2014]

For a short explanation of why the committee made the 2023 recommendation and how it might affect practice, see the rationale and impact section on cardioprotective diet.

Full details of the evidence and the committee's discussion are in evidence review B: dietary cholesterol strategies.

Physical activity

1.3.6

Encourage people who are unable to perform moderate intensity physical activity because of comorbidity, medical conditions or personal circumstances to exercise at their maximum safe capacity. [2008, amended 2014]

Weight management

Alcohol consumption

Smoking cessation

Plant stanols and sterols

1.3.12

Do not advise any of the following to take plant stanols or sterols to prevent CVD:

  • people being treated for primary prevention

  • people being treated for secondary prevention

  • people with CKD

  • people with type 1 diabetes

  • people with type 2 diabetes. [2014]

1.4 Initial lipid measurement and referral for specialist review

1.4.1

Measure both total blood cholesterol and high-density lipoprotein (HDL) cholesterol to achieve the best estimate of CVD risk. [2008]

1.4.2

Use clinical findings, a full lipid profile and family history to judge the likelihood of a familial lipid disorder, rather than using strict lipid cut-off values alone. [2014, amended December 2023]

1.4.3

Exclude possible common secondary causes of dyslipidaemia (such as excess alcohol intake, uncontrolled diabetes, hypothyroidism, liver disease and nephrotic syndrome) before referring for specialist review. [2014]

1.4.5

Arrange for specialist assessment of people with a total blood cholesterol level of more than 9.0 mmol per litre or a non-HDL cholesterol level of more than 7.5 mmol per litre even in the absence of a first-degree family history of premature coronary heart disease. [2014]

1.4.6

Refer for urgent specialist review if a person has a triglyceride level of more than 20 mmol per litre that is not a result of excess alcohol intake or poor glycaemic control. [2014]

1.4.7

In people with a triglyceride level between 10 mmol and 20 mmol per litre:

  • repeat the triglyceride measurement with a fasting test (after an interval of 5 days, but within 2 weeks) and

  • review for potential secondary causes of hyperlipidaemia and

  • seek specialist advice if the triglyceride level remains at more than 10 mmol per litre. [2014]

1.4.8

In people with a triglyceride level between 4.5 mmol and 9.9 mmol per litre:

  • be aware that the CVD risk may be underestimated by risk assessment tools and

  • optimise the management of other CVD risk factors present and

  • seek specialist advice if non-HDL cholesterol level is more than 7.5 mmol per litre. [2014]

1.5 Discussions and assessment before starting statins

Discuss risks and benefits of statins

1.5.1

Make decisions about starting statin treatment after an informed discussion between the clinician and the person about the risks and benefits of statins. [May 2023, amended December 2023]

1.5.2

Take into account potential benefits from lifestyle changes, the person's preferences, the presence of any comorbidities, whether they are on multiple medications, whether they are frail and their life expectancy. (See also NICE's guideline on multimorbidity.) [May 2023, amended December 2023]

1.5.3

Advise people who are being offered a statin that the risk of muscle pain, tenderness or weakness associated with statin use is small and the rate of severe muscle adverse effects (rhabdomyolysis) because of statins is extremely low. [May 2023]

Discuss possible interactions between statins and other substances

1.5.4

Advise people who are being treated with a statin:

  • that other drugs, some foods (for example, grapefruit juice) and some supplements may interfere with statins and

  • to always consult the patient information leaflet, a pharmacist or prescriber for advice when starting other drugs or thinking about taking supplements. [May 2023]

Perform baseline blood tests and clinical assessment

1.5.5

Before starting statins perform baseline blood tests and clinical assessment. Include all of the following in the assessment:

1.5.6

Do not routinely exclude from statin treatment people who have liver transaminase levels that are raised but are less than 3 times the upper limit of normal. [May 2023]

1.5.7

Before offering a statin, ask the person if they have had persistent generalised unexplained muscle symptoms (pain, tenderness or weakness), whether associated or not with previous lipid-lowering treatment. If they have, measure creatine kinase levels. If creatine kinase levels are:

  • more than 5 times the upper limit of normal, re-measure creatine kinase after 7 days; if creatine kinase levels are still 5 times the upper limit of normal, do not start statin treatment (see the section on when statins are contraindicated or not tolerated)

  • raised but less than 5 times the upper limit of normal, start statin treatment at a lower dose. [May 2023]

For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on discussions and assessment before starting statins.

Full details of the evidence and the committee's discussion are in evidence review C: statins: efficacy and adverse effects.

Choice of drug based on clinical trials

1.5.8

Be aware that when deciding on lipid-lowering treatment to prevent CVD, drugs are preferred for which there is evidence in clinical trials of a beneficial effect on CVD morbidity and mortality. [2008]

Statins and pregnancy

1.5.9

Be aware that statins are contraindicated in pregnancy because of the risk to the unborn child of exposure to statins. [2014, amended May 2023]

1.5.10

Explain that:

  • statins should be stopped if pregnancy is a possibility

  • statins should be stopped 3 months before attempting to conceive

  • statins should not be restarted until breastfeeding is finished. [2014, amended May 2023]

1.6 Statins for primary prevention of cardiovascular disease

There is a NICE patient decision aid to support discussions about statin treatment to reduce the risk of heart disease and stroke for people without CVD.

Lipid target for people taking statins

1.6.1

For primary prevention of CVD aim for a greater than 40% reduction in non-HDL cholesterol. [May 2023]

Optimising lifestyle changes

1.6.2

Before offering statin treatment for primary prevention, discuss the benefits of lifestyle changes and optimise the management of all other modifiable CVD risk factors if possible. [May 2023]

1.6.4

Offer people the opportunity to have their risk of CVD assessed again after they have tried to change their lifestyle. [May 2023]

1.6.5

If lifestyle change is ineffective or inappropriate offer statin treatment. [May 2023]

Treating comorbidities and secondary causes of dyslipidaemia

1.6.6

Before starting statins, treat comorbidities and secondary causes of dyslipidaemia. [May 2023]

People with and without type 2 diabetes

1.6.7

Offer atorvastatin 20 mg for the primary prevention of CVD to people who have a 10‑year QRISK3 score of 10% or more. [May 2023]

1.6.8

Do not rule out treatment with atorvastatin 20 mg for the primary prevention of CVD just because the person's 10‑year QRISK3 score is less than 10% if they have an informed preference for taking a statin or there is concern that risk may be underestimated. [May 2023]

1.6.9

For people aged 85 and older consider treatment with atorvastatin 20 mg. Be aware of factors that may make treatment inappropriate (see recommendations 1.5.1 and 1.5.2). [May 2023]

People with type 1 diabetes

1.6.10

Offer statin treatment for the primary prevention of CVD to adults with type 1 diabetes who:

  • are older than 40 years or

  • have had diabetes for more than 10 years or

  • have established nephropathy or

  • have other CVD risk factors. [May 2023]

1.6.11

Consider statin treatment for the primary prevention of CVD for people aged 18 to 40 with type 1 diabetes, including those who have had diabetes for 10 years or less. [May 2023, amended December 2023]

1.6.12

When starting treatment with a statin for adults with type 1 diabetes, use atorvastatin 20 mg. [May 2023]

For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on statins for primary prevention of CVD.

Full details of the evidence and the committee's discussion are in evidence review C: statins: efficacy and adverse effects.

Optimising treatment for people on statins

Assessing response to treatment

1.7 Lipid-lowering treatment for secondary prevention of cardiovascular disease

These recommendations apply to people with and without type 1 and 2 diabetes.

Lipid target for people taking lipid-lowering treatments

1.7.1

For secondary prevention of CVD, aim for low-density lipoprotein (LDL) cholesterol levels of 2.0 mmol per litre or less, or non-HDL cholesterol levels of 2.6 mmol per litre or less. [December 2023]

For a short explanation of why the committee made this recommendation and how it might affect practice, see the rationale and impact section on lipid target for secondary prevention of CVD.

Full details of the evidence and the committee's discussion are in evidence review D: escalation of lipid-lowering treatment for secondary prevention of CVD.

As part of the December 2023 update, a new NICE indicator was developed to support quality improvement in managing cholesterol levels for people with CVD. This NICE indicator is suitable for inclusion in local and national general practice measurement frameworks, including those underpinned with financial incentives:

NM252: The percentage of patients with CVD in whom the last recorded LDL cholesterol level (measured in the preceding 12 months) is 2.0 mmol per litre or less, or last recorded non-HDL cholesterol level (measured in the preceding 12 months) is 2.6 mmol per litre or less, if LDL cholesterol is not recorded.

Initial treatment

1.7.2

Offer atorvastatin 80 mg to people with CVD, whatever their cholesterol level, unless the person meets the criteria in recommendation 1.7.3. [May 2023, amended December 2023]

1.7.3

Offer a lower dose of atorvastatin if any of the following apply:

  • it could react with other drugs

  • there is a high risk of adverse effects

  • the person would prefer to take a lower dose. [May 2023, amended December 2023]

    In December 2023, this was an off-label use of atorvastatin. See NICE's information on prescribing medicines.

1.7.4

Do not delay statin treatment for secondary prevention of CVD but discuss lifestyle changes at the same time if appropriate. [May 2023, amended December 2023]

1.7.5

If a person has acute coronary syndrome, do not delay statin treatment. Measure full lipid profile on admission and at 2 to 3 months after starting treatment. [May 2023, amended December 2023]

For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on statins for secondary prevention of CVD.

Full details of the evidence and the committee's discussion are in evidence review C: statins: efficacy and adverse effects.

Treating comorbidities and secondary causes of dyslipidaemia

1.7.6

Treat comorbidities and secondary causes of dyslipidaemia at the same time as starting statin treatment. [December 2023]

Optimising treatment for people on statins

Escalating treatment for people on statins

1.7.8

Make decisions about escalating lipid-lowering treatment after an informed discussion between the clinician and the person about the risks and benefits of additional lipid-lowering treatments. [December 2023]

1.7.9

Take into account the person's preferences, the presence of any comorbidities, whether they are on multiple medications, whether they are frail and their life expectancy. (See also NICE's guideline on multimorbidity.) [December 2023]

1.7.11

Consider ezetimibe in addition to the maximum tolerated intensity and dose of statin to reduce CVD risk further, even if the lipid target for secondary prevention of CVD is met (see recommendation 1.7.1). [December 2023]

For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on lipid target for secondary prevention of CVD.

Full details of the evidence and the committee's discussion are in evidence review D: escalation of lipid-lowering treatment for secondary prevention of CVD.

Assessing response to treatment

1.8 Statins for primary and secondary prevention of cardiovascular disease in people with chronic kidney disease

See NICE's guideline on chronic kidney disease for CKD classification. People on renal replacement therapy are outside the scope of this guideline.

1.8.1

Offer atorvastatin 20 mg for the primary or secondary prevention of CVD to people with CKD. [May 2023]

1.8.2

If the lipid target for primary or secondary prevention of CVD (see recommendation 1.6.1 and recommendation 1.7.1) is not met and eGFR is 30 ml per minute per 1.73 m2 or more, increase the dose of atorvastatin. [May 2023, amended December 2023]

1.8.3

Agree the use of higher doses with a renal specialist if eGFR is less than 30 ml per minute per 1.73 m2. [May 2023]

Optimising treatment for people on statins

Assessing response to treatment

1.9 Optimising treatment for people on statins

1.9.1

If the lipid target for primary or secondary prevention of CVD (see recommendation 1.6.1 and recommendation 1.7.1) is not met:

  • discuss adherence and timing of statin dose with the person

  • encourage them to continue improvements to their diet and lifestyle, and to make further changes if appropriate

  • consider increasing the statin intensity/dose if the person is not currently taking a high-intensity statin at the maximum tolerated dose. [May 2023, amended December 2023]

1.9.2

If the person reports adverse effects when taking a high-intensity statin, discuss the following strategies with them:

  • stopping the statin and trying again when the symptoms have resolved to check if the symptoms are related to the statin

  • changing to a different statin in the same intensity group (rosuvastatin if already receiving atorvastatin)

  • reducing the dose

  • changing to a lower-intensity statin. [2014, amended May 2023 and December 2023]

1.9.3

If a person is not able to tolerate a high-intensity statin, aim to treat with the maximum tolerated intensity and dose of statin. [2014, amended December 2023]

1.9.4

Advise the person that any statin at any dose reduces CVD risk. [2014, amended May 2023 and December 2023]

For a short explanation of why the committee made the 2023 recommendation and how it might affect practice, see the rationale and impact section on optimising treatment for people on statins.

Full details of the evidence and the committee's discussion are in evidence review C: statins: efficacy and adverse effects.

1.10 Statins are contraindicated or not tolerated

Secondary prevention of cardiovascular disease

For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on lipid target for secondary prevention of CVD.

Full details of the evidence and the committee's discussion are in evidence review D: escalation of lipid-lowering treatment for secondary prevention of CVD.

Assessing response to treatment

1.11 Assessing response to treatment

When to repeat blood tests

1.11.1

Measure liver transaminase and full lipid profile at 2 to 3 months after starting or changing lipid-lowering treatment. [May 2023, amended December 2023]

1.11.2

Measure liver transaminase at 12 months, but not again unless clinically indicated. [May 2023, amended December 2023]

When to measure creatine kinase

1.11.3

Advise people who are being treated with a statin to seek medical advice if they develop unexplained muscle symptoms (pain, tenderness or weakness). If this occurs, measure creatine kinase. [May 2023]

1.11.4

If people report muscle pain, tenderness or weakness while taking a statin and have a creatine kinase level less than 5 times the upper limit of normal, reassure them that their symptoms are unlikely to be due to the statin and explore other possible causes. [May 2023]

1.11.5

Do not measure creatine kinase levels in asymptomatic people who are being treated with a statin. [May 2023]

Increase in blood glucose or HbA1c

Restarting statins

1.11.7

Remind the person to restart the statin if they stopped taking it because of drug interactions or to treat intercurrent illnesses. [May 2023]

Annual medication review

1.11.8

Provide annual medication reviews for people on lipid-lowering treatment. [May 2023, amended December 2023]

1.11.9

Offer an annual full lipid profile to inform discussions about secondary prevention of CVD. [May 2023, amended December 2023]

1.11.10

Consider an annual full lipid profile to inform discussions about primary prevention of CVD. [May 2023, amended December 2023]

1.11.11

During the annual medication review:

  • discuss and encourage medicines adherence, if the shared decision is to continue with lipid-lowering treatment

  • discuss and encourage dietary and lifestyle changes if appropriate

  • address CVD risk factors. [May 2023, amended December 2023]

For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on assessing response to treatment.

Full details of the evidence and the committee's discussion are in evidence review C: statins: efficacy and adverse effects.

1.12 Lipid-lowering treatments that should not be used or not used routinely

These recommendations apply to primary and secondary prevention of CVD, including people with diabetes and CKD.

They do not apply to people with familial hypercholesterolaemia. For guidance on using fibrates, bile acid sequestrants and combination treatment for this population group, follow the recommendations on drug treatment in NICE's guideline on familial hypercholesterolaemia.

Adherence to statin treatment

1.12.1

Do not offer coenzyme Q10 or vitamin D to increase adherence to statin treatment. [2014]

Fibrates

1.12.2

Do not routinely offer fibrates to prevent CVD. [2014, amended December 2023]

Nicotinic acid

1.12.3

Do not offer nicotinic acid (niacin) to prevent CVD. [2014, amended December 2023]

Bile acid sequestrants (anion exchange resins)

1.12.4

Do not offer a bile acid sequestrant (anion exchange resin) to prevent CVD. [2014, amended December 2023]

Omega 3 fatty acid compounds

1.12.6

Tell people that there is no evidence that omega 3 fatty acid compounds help to prevent CVD, except use of icosapent ethyl as described in NICE's technology appraisal guidance on icosapent ethyl with statin therapy. [2014]

Combination treatment

Terms used in this guideline

This section defines terms that have been used in a particular way for this guideline.

Full lipid profile

This involves taking a blood sample to measure total cholesterol, HDL cholesterol and triglyceride levels and then calculating non-HDL cholesterol and LDL cholesterol (a fasting sample is not mandated). LDL cholesterol results may not be reported in participants with triglyceride levels more than 4.5 mmol per litre or 9 mmol per litre depending on the formula used by local laboratories.

High-intensity statin

The following doses for statins are high intensity, based on the percentage reduction in LDL cholesterol they can produce:

  • atorvastatin: 20 mg to 80 mg

  • rosuvastatin: 10 mg to 40 mg.

Medium-intensity statin

The following doses for statins are medium intensity, based on the percentage reduction in LDL cholesterol they can produce:

  • atorvastatin: 10 mg

  • fluvastatin: 80 mg

  • rosuvastatin: 5 mg

  • simvastatin: 20 mg to 40 mg.

Low-intensity statin

The following doses for statins are low intensity, based on the percentage reduction in LDL cholesterol they can produce:

  • fluvastatin: 20 mg to 40 mg

  • pravastatin: 5 mg to 40 mg

  • simvastatin: 10 mg.

Severe mental illness

A diagnosis of schizophrenia, bipolar disorder or other psychoses. (In line with the criteria for severe mental health conditions used in the NHS annual health check for people with severe mental health conditions.)