Nice | Lipid modification in cardiovascular disease – primary and secondary prevention

This is a summary of the somewhat controversial updated guideline from NICE on lipids. You could probably only have failed to notice the uproar surrounding this is you'd been living on Mars for the last few months. I am just summarising the guideline here, but please comment if you feel strongly about it!

I have listed some 'Take Home Messages', then a more comprehensive summary below.

Take home messages

Measure lipids on a non-fasting sample. Take note of the 'Total Cholesterol' (TC) and the 'Non-HDL' levels (ie TC - HDL).

Use QRISK2 as the standard risk scoring tool UNLESS the patient has:

  • CKD with GFR < 60 and / or albuminuria
  • Type 1 diabetes (NB you can use QRISK2 for T2DM and manage people as you otherwise would)
  • Age 85 or over (assume they are high risk)
  • Familial Hypercholesterolaemia (beware TC > 7.5 AND a FHx of premature CVD.

Primary Prevention - if the risk is 10% per 10 years or more, offer lifestyle advice initially, then atorvastatin 20mg

Type 1 Diabetes - consider using atorvastatin at any age, but especially if over 40 or other risk factors (see the full summary below).

CKD - use atorvastatin 20mg

Secondary Prevention - use atorvastatin 80mg (unless they have CKD in which case use 20mg).

Non-statin drugs - only ezetimibe should be routinely used.

Target Cholesterol - aim for a 40% reduction in non-HDL cholesterol after 3m

What tests should we be doing?

Non-fasting sample (which is why they aren't bothering with LDL which requires a fasting sample).

Before starting statins, you also need to have measured:

  • HbA1c (to ensure poor glycaemic control isn't responsible for the poor lipid profile)
  • Renal Function (may alter management, also nephrotic syndrome can alter the lipid profile)
  • LFT (NB don't withold statins if the transaminases are < 3 times the upper limit of normal (ULN))
  • TSH (hypothyroidism can alter the lipid profile)

QRISK2

This should be used for most people up to the age of 84, apart from with the conditions listed in the 'Take Home Messages'. Beware that some conditions are not considered by QRISK2, which may further increase someone's risk:

  • Treated for HIV
  • Serious mental health problems
  • Medications – eg antipsychotics / corticosteroids / immunosuppressant drugs
  • Autoimmune disorders (eg SLE)
  • Already taking antihypertensives / treatment for lipids / recently stopped smoking.
  • BMI > 40
  • TAG 4.5-9.9

Statin classification

NICE have classified statins according to their effectiveness. The following are considered 'high-intensity': Simvastatin 80mg, Atorvastatin 20mg and above, Rosuvastatin 10mg and above.

Lifestyle advice

All patients should be given lifestyle advice. There is a handy summary on the NICE information for patients.

In primary prevention, patients should be given the chance to optimise all other risk factors, before statin therapy is started.

Primary prevention - drug management

Atorvastatin 20mg should be offered first-line if:

  • 10% or more risk over 10 yrs (for those recently back from Mars - this is the controversial bit!)
  • Age 85 or more (ie all patients, though NICE does advice discussing risks, benefits and things like life-expectancy)
  • Type 1 Diabetes - consider for all adult patients, but offer if:
  1. 40 or older
  2. Had diabetes for 10 yrs or more
  3. Established nephropathy
  4. Other risk factors for CVD
  • CKD (NB - if GFR < 30, discuss with specialist before increasing the atorvastatin> 20mg).

Secondary prevention - drug management

Atorvastatin 80mg (but a lower dose if there are potential drug reactions / side-effects etc)

Atorvastatin 20mg if there is CKD

Management of muscle aches

If patients suffer with muscle aching before starting a statin, check CK. If the levels are 5 or more times above the upper limit of normal, remeasure after a week and if there is no drop, start a lower dose of statin.

If they get muscle aches on the statin (or weakness or tenderness) then check CK. If the statin has previously been tolerated for more than 3 months, consider other causes.

Management of side-fffects

Use the maximum tolerated dose.

Try stopping, then re-starting the statin to see if the side-effect is actually due to the statin

Try changing to a lower intensity statin if still not tolerated

If the patient is high risk (ie CKD / Diabetes / familial hypercholesterolaemia or CVD) and is intolerant to 3 different statins, consider referral.

Pregnancy

Warn women of child-bearing age that they should stop statins 3m before trying to conceive and should not restart until breast-feeding has stopped.

Use of non-statin drugs

Do NOT use nicotinic acid, bile acid sequestrants or omega-3 fatty acid compounds.

Fibrates shouldn't routinely be used.

Ezetimibe - there is separate guidance from NICE for this. Basically ezetimibe can be considered if the patient is either not tolerant to statins or if they are contra-indicated. It can also be used in combination with a statin if you can't reach the advised targets for treatment. The guideline doesn't seem to specify whether it can be used for both primary and secondary prevention.

Target cholesterol levels

You should remeasure levels at 3 months and aim for a reduction of 40% or more in non-HDL. If this isn't achieved, discuss concordance with dosing and timing and discuss lifestyle. You should increase the dose if they are on less than 80mg, 'if they are judged to be at higher risk'. This can be based on their risk score, comorbidities or 'clinical judgement'.

When should you refer?

  • High risk patients not tolerant to 3 different statins as above
  • TC > 9
  • Non-HDL > 7.5
  • TAG > 20  - urgent referral (if not due to alcohol / poorly controlled diabetes)
  • TAG 10-20 - rpt with fasting sample between 5-14 days and refer if still over 10 and no obvious secondary causes.
  • TAG 4.5-9.9 – if non-HDL also > 7.5.

How should we be explaining the risk to the patients?

NICE uses the wonderful phrase 'The decision to start statin therapy should be made after an informed discussion between the clinician and the person about the risks and benefits of statin treatment...'. They aren't very good at actually giving us any help with this - and again this is a controversial topic. In the coming months, NICE are meant to be creating a 'Patient Decision Aid', which may make this discussion easier.
NNT. The NICE guideline doesn't list any 'Numbers Needed to Treat (NNT)', which is a shame, as they are a nice easy way to explain benefits to patient. A recent BMJ review quoting the director of NICE gives an NNT at 10% risk over 10 yrs of 77 people treated over 3 years to reduce one death, stroke or non-fatal MI. To put this into perspective, for antihypertensive treatment, the NNT is apparently 104.
The MHRA released an excellent summary of the benefits and the risks of muscle related side-effects.
The JBS website has an excellent risk calculator. It takes a bit of practice to know what to put where, but it gives a lovely, easy to understand visual representation of the patient's risk and how that risk can be affected by different interventions.

Louise Hudman

I'm a freelance GP locum in Winchester & Southampton locum chambers, and Pallant Medical Chambers Clinical Guidelines Lead Partner.

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