Quality standard

Quality statement 6: Drug treatment in adults

Quality statement

Adults with familial hypercholesterolaemia (FH) receive lipid‑modifying drug treatment to reduce LDL‑C concentration by more than 50% from baseline.

Rationale

Lipid‑modifying drug treatment reduces LDL‑C levels and prevents the development of cardiovascular disease. Studies indicate that treatment that lowers LDL‑C levels by more than 50% from baseline offers greater benefit for plaque stabilisation than treatment that is less effective at reducing LDL‑C.

Quality measures

The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.

Structure

Evidence of local arrangements to ensure that adults with FH receive lipid‑modifying drug treatment to reduce LDL‑C concentration by more than 50% from baseline.

Data source: Local data collection.

Process

Proportion of adults with FH who receive appropriate lipid‑modifying drug treatment.

Numerator – The number of people in the denominator receiving appropriate lipid‑modifying drug treatment.

Denominator – The number of adults with FH.

Data source: Local data collection.

Outcome

Number of adults with FH whose LDL‑C concentration is reduced by more than 50% from baseline within 1 year.

Data source: Local data collection using a dedicated database.

What the quality statement means for different audiences

Service providers ensure that systems are in place for adults with FH to receive lipid‑modifying drug treatment to reduce LDL‑C concentration by more than 50% from baseline.

Healthcare practitioners offer adults with FH lipid‑modifying drug treatment to reduce LDL‑C concentration by more than 50% from baseline.

Commissioners ensure that they commission services that offer adults with FH lipid‑modifying drug treatment to reduce LDL‑C concentration by more than 50% from baseline.

Adults with FH are offered drugs to reduce the low‑density cholesterol (bad cholesterol) in their blood to less than a half of the level before treatment.

Source guidance

Familial hypercholesterolaemia: identification and management. NICE guideline CG71 (2008, updated 2019), recommendations 1.3.1.2 to 1.3.1.4, 1.3.1.6 to 1.3.1.8 and 1.3.1.14

Definitions of terms used in this quality statement

Familial hypercholesterolaemia (FH)

FH relates to heterozygous FH only.

Adults with FH

Adults (aged 16 and older) should have a diagnosis of FH made by a specialist with expertise in FH.

Baseline LDL‑C

The concentration before treatment.

Lipid-modifying drug treatment

Lipid-modifying drug treatment should be given in accordance with the following:

  • to achieve the recommended reduction:

    • offer a high‑intensity statin with the lowest acquisition cost as the initial treatment

    • increase dose of statin to maximum licensed or tolerated dose

  • ezetimibe monotherapy is recommended if the person is intolerant to statin therapy or there are contraindications to initial statin therapy

  • co-administer ezetimibe with initial statin therapy when serum total or LDL‑C concentration is not appropriately controlled and a change from initial statin therapy to an alternative statin is being considered.

Statins are classified as high intensity if they produce greater LDL-C reductions than simvastatin 40 mg (for example, simvastatin 80 mg and appropriate doses of atorvastatin and rosuvastatin).

Treatment for FH is usually provided by either a specialist with expertise in FH or a GP through a shared care arrangement.

[Adapted from NICE's guideline on familial hypercholesterolaemia, recommendations 1.3.1.2 to 1.3.1.6, 1.3.1.11, and terms used in this guideline]

Equality and diversity considerations

The statement has been restricted to adults only because there is currently no evidence on which to base any specific target for lowering LDL‑C in children and young people under 16 years. However, lipid‑modifying drug treatment should be considered by the age of 10 years in line with NICE's guideline on familial hypercholesterolaemia.

Women with FH should be advised that lipid‑modifying drug treatment should not be taken if they are planning to conceive or during pregnancy because of the risk of fetal abnormality. Women should be advised that lipid‑modifying drug treatment should be stopped 3 months before they attempt to conceive. Women with FH should be advised about the potential risks and benefits of re-starting lipid‑modifying drug treatment for the mother and breastfed infant. Resins are the only lipid‑modifying drug treatment that should be considered during breastfeeding.