NICE recommends using simvastatin 40 mg as first-choice statin for primary prevention in people at 20% or greater 10-year cardiovascular disease (CVD) risk. In primary prevention, no specific lipid targets are given (i.e. a “fire and forget” approach).
Simvastatin 40 mg is also recommended as first-choice statin for secondary prevention. According to the full guideline (page 190), modelling suggests that titration with simvastatin 80 mg could be considered for secondary prevention patients whose total cholesterol does not decrease to less than 4 mmol/L as long as titration stops at simvastatin 80mg. More than half of patients will not attain these levels and modelling suggests that it is not cost-effective to try to take more patients to a 4mmol/L target using higher cost statins such as atorvastatin.
Patients with acute coronary syndrome (ACS) should be offered high-intensity statins.
Patients need to be given information about their absolute risk of CVD and the likely absolute benefits and harms of treatment in ways meaningful to them – see the decision aids on the lipids section of NPC. The Framingham equation should be used to assess CV risk in people without established disease, within a systematic strategy to identify people aged over 40 at high risk. Lipid management should be only part of the strategy to reduce risk, along with smoking cessation, healthy eating, exercise, etc.
This NICE guidance needs to be read carefully by everyone involved in looking after patients at risk of CVD, and those who advise in this therapeutic area.
Does NICE recommend a lipid target of 4 mmol/L (total cholesterol) and 2 mmol/L (LDL cholesterol)?
No, it does not. In primary prevention no lipid targets are given at all – simvastatin 40 mg is the first-choice drug with the option to use a lower dose “or [an] alternative preparation such as pravastatin” if there are potential drug interactions, or simvastatin 40 mg is contraindicated. No further monitoring is recommended by NICE (although we note that, pragmatically, monitoring may be required for purposes of the QoF).
In secondary prevention, simvastatin 40 mg is also the first-choice drug, with pravastatin as the named alternative. Clinicians are advised to consider increasing to simvastatin 80 mg in secondary prevention patients if a total cholesterol of less than 4 mmol/L or an LDL-cholesterol of less than 2 mmol/L is not attained. However, this should take into account the patient’s informed preference, comorbidities, multiple drug therapy, and the absolute benefit and risks of treatment. The evidence from trials of high-dose statins in stable CVD (TNT and IDEAL) suggest only limited benefits from high-dose treatment, but an increased risk of side effects. NICE also suggests that “a drug of similar efficacy and acquisition cost” to simvastatin 80 mg could be considered. However, only higher-dose atorvastatin has clinical outcome data but its acquisition costs are substantially greater at present.
An ‘audit’ level of total cholesterol of 5 mmol/L is recommended by NICE for assessing progress in populations or groups of people with CVD. This is in recognition that more than half of patients will not achieve a total cholesterol of less than 4 mmol/L or an LDL-cholesterol of less than 2 mmol/L.
NICE recommends that patients with ACS should be offered a high-intensity statin, that is a statin used in doses that produce greater cholesterol lowering than simvastatin 40 mg, for example simvastatin 80 mg. However, lipid targets in ACS are not specifically stated, nor is guidance given on the duration of high-intensity statin treatment if it is used.