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.

At the time of publication (July 2016), neither pioglitazone nor vitamin E had a UK marketing authorisation for the treatment of non-alcoholic fatty liver disease (NAFLD). The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.

1.1 Assessment for NAFLD

Identifying NAFLD in higher-risk groups

1.1.1

Be aware that non-alcoholic fatty liver disease (NAFLD) is more common in people who have:

  • type 2 diabetes or

  • metabolic syndrome.

1.1.3

Do not use routine liver blood tests to rule out NAFLD.

Diagnosing NAFLD in children and young people

1.1.4

Offer a liver ultrasound to test children and young people for NAFLD if they:

  • have type 2 diabetes or metabolic syndrome and

  • do not misuse alcohol.

1.1.5

Refer children with suspected NAFLD to a relevant paediatric specialist in hepatology in tertiary care.

1.1.6

Diagnose children and young people with NAFLD if:

  • ultrasound shows they have fatty liver and

  • other suspected causes of fatty liver have been ruled out.

1.1.7

Offer liver ultrasound to retest children and young people for NAFLD every 3 years if they:

  • have a normal ultrasound and

  • have type 2 diabetes or metabolic syndrome and

  • do not misuse alcohol.

1.2 Assessment for advanced liver fibrosis in people with NAFLD

Identifying people with advanced liver fibrosis

1.2.1

Offer testing for advanced liver fibrosis to people with NAFLD.

1.2.2

Consider using the enhanced liver fibrosis (ELF) test in people who have been diagnosed with NAFLD to test for advanced liver fibrosis.

1.2.3

Do not use routine liver blood tests to assess for advanced liver fibrosis in people with NAFLD.

1.2.4

Diagnose people with advanced liver fibrosis if they have:

  • an ELF score of 10.51 or above and

  • NAFLD.

1.2.5

Refer adults and young people diagnosed with advanced liver fibrosis to a relevant specialist in hepatology.

1.2.6

Explain to people with an ELF score below 10.51 that:

  • they are unlikely to have advanced liver fibrosis and

  • reassessment for advanced liver fibrosis every 3 years for adults and every 2 years for children and young people is sufficient for regular monitoring and

  • no interim tests are needed.

    Give the person advice about lifestyle modifications they may be able to make (see section 1.2).

1.2.7

Offer retesting for advanced liver fibrosis for people with an ELF score below 10.51:

  • every 3 years to adults

  • every 2 years to children and young people.

1.2.8

Consider using ELF for retesting people with advanced liver fibrosis.

Monitoring adults and young people over 16 for cirrhosis

Extra-hepatic conditions

1.2.10

Be aware that NAFLD is a risk factor for type 2 diabetes, hypertension and chronic kidney disease.

1.2.11

Be aware that in people with type 2 diabetes, NAFLD is a risk factor for atrial fibrillation, myocardial infarction, ischaemic stroke and death from cardiovascular causes.

Lifestyle modifications for NAFLD

1.2.13

Explain to people with NAFLD that there is some evidence that exercise reduces liver fat content.

1.2.15

Do not offer omega-3 fatty acids to adults with NAFLD because there is not enough evidence to recommend their use.

1.2.16

Explain to people with NAFLD who drink alcohol the importance of staying within the national recommended limits for alcohol consumption.

1.3 People with NAFLD who are taking statins

1.3.1

Be aware that people with NAFLD who are taking statins should keep taking them.

1.3.2

Only consider stopping statins if liver enzyme levels double within 3 months of starting statins, including in people with abnormal baseline liver blood results.

1.4 Pharmacological treatment

In July 2016, the use of pioglitazone and vitamin E in recommendations 1.4.1 to 1.4.5 was off label.

See NICE's information on prescribing medicines.

1.4.1

In secondary or tertiary care settings only, consider pioglitazone or vitamin E for adults with advanced liver fibrosis, whether they have diabetes or not.

1.4.2

Before prescribing pioglitazoneor vitamin E to adults, take into account any comorbidities that they have and the risk of adverse events associated with these conditions.

1.4.3

When prescribing pioglitazone, exercise particular caution if the person is at high risk of the adverse effects of the drug. Be aware that:

  • pioglitazone is contraindicated in people with a history of heart failure, previous or active bladder cancer and uninvestigated macroscopic haematuria (visible red blood cells in the urine)

  • known risk factors for these conditions, including increased age, should be carefully evaluated before treatment: see the manufacturers' summaries of product characteristics for details.

1.4.4

In tertiary care settings only, consider vitamin E for children with advanced liver fibrosis, whether they have diabetes or not.

1.4.5

In secondary or tertiary care settings only, consider vitamin E for young people with advanced liver fibrosis, whether they have diabetes or not.

1.4.6

Offer to retest people with advanced liver fibrosis 2 years after they start a new pharmacological therapy to assess whether treatment is effective.

1.4.7

Consider using the ELF test to assess whether pharmacological therapy is effective.

1.4.8

If an adult's ELF test score has risen, stop either vitamin E or pioglitazone and consider switching to the other pharmacological therapy.

1.4.9

If a child or young person's ELF test score has risen, stop vitamin E.

Terms used in this guideline

Advanced liver fibrosis

A grade of F3 or above using the Kleiner (NASH-CRN) or the steatosis, activity and fibrosis (SAF) score. This is referred to as bridging fibrosis (the presence of fibrosis linking hepatic veins to portal tracts).

Adults, children and young people

These are defined as:

  • Children: over 1 year to under 16 years.

  • Young people: 16 to under 18.

  • Adults: 18 or older.

Metabolic syndrome

A group of chronic conditions that indicates increased cardiovascular risk. It includes central obesity (excessive abdominal fat), insulin resistance or type 2 diabetes, hypertension and dyslipidaemia.