|Therapeutic Area||Formulary Choices||Cost for 28|
(unless otherwise stated)
|Rationale for decision / comments|
|2.12 Lipid-regulating drugs||Related guidance: Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease
Peripheral arterial disease: diagnosis and management
|Monitoring of statin treatment for primary and secondary prevention:
• People on a statin should be advised to seek medical advice if they develop muscle symptoms (pain, tenderness or weakness). If this occurs, creatine kinase should be measured.
•Creatine kinase should not be routinely monitored in asymptomatic people who are being treated with a statin.
• Baseline liver enzymes should be measured before starting a statin. Liver function (transaminases) should be measured within 3 months of starting treatment and at 12 months, but not again unless clinically indicated.
• People who have liver enzymes (transaminases) that are raised but are less than 3 times the upper limit of normal should not be routinely excluded from statin therapy.
• If a person develops an unexplained peripheral neuropathy, statins should be discontinued and specialist advice sought.
It is recommended that attempts should always be made to get patients to national cholesterol levels with statin monotherapy, using all formulary statins, before consideration is given to adding in or changing to another agent.
A summary of drug–statins interactions is included in this chapter.
|First line:||Atorvastatin||10mg tablets: £0.89|
20mg tablets: £1.04
40mg tablets: £1.24
80mg tablets: £2.03
|Atorvastatin is first line statin for all new patients unless contra-indicated. It is included in the formulary for:
• Primary prevention of cardiovascular events (where 10 year CVD risk ≥ 10%)
• Secondary prevention of CV events (give 80mg)
|10mg tablets: £0.67|
20mg tablets: £0.76
40mg tablets: £0.84
80mg tablets: £1.68
10mg tablets: £0.60
20mg tablets: £0.69
40mg tablets: £0.77
80mg tablets: £1.82
• Simvastatin should be prescribed at night to optimise effect.
• Simvastatin 10mg should only be prescribed for patients who cannot tolerate a higher evidence-based dose of statin therapy
• See BNF or SPC for further information on interactions
• There is an increased risk of myopathy associated with high-dose (80mg) simvastatin. The 80mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who have not achieved their treatment goals on lower doses, when the benefits are expected to outweigh the potential risks. (see MHRA Drug Safety Update May 2010; 3 (10))
|Second line:||Pravastatin||10mg tablets: £0.91|
20mg tablets: £1.10
40mg tablets: £1.37
|It should be noted that the maximum reduction in total cholesterol which can be expected from Pravastatin is 24%. However, pravastatin is not liver metabolised like the others, which may explain why it is generally better tolerated.|
|Third line:||Rosuvastatin||5mg tablets: £18.03|
10mg tablets: £18.03
20mg tablets: £26.02
40mg tablets: £29.69
|Higher intensity statins should not routinely be offered to people for the primary prevention of CVD. A target for total or LDL cholesterol is not recommended for people who are treated with a statin for primary prevention of CVD.
Rosuvastatin is contra-indicated in patients with severe renal impairment (creatinine clearance <30 ml/min. The 40mg dose is contra-indicated in moderate renal impairment (creatinine clearance < 60 ml/min).
Pravastatin and Rosuvastatin have a different metabolic pathway so may be tolerated when Simvastatin or Atorvastatin are not.
|Other lipid lowering drugs||In general, the evidence for an effect on outcomes is less robust than for statin therapy. Additional monitoring may be required, particularly when Fibrates or Nicotinic Acid are used in combination with statins, due to increased risk of myopathy.|
|Ezetimibe||10mg tablets: £26.31||Ezetimibe monotherapy is recommended as an option for treating primary (heterozygous‑familial or non‑familial) hypercholesterolaemia in adults in whom initial statin therapy is contraindicated.
Ezetimibe monotherapy is recommended as an option for treating primary (heterozygous‑familial or non‑familial) hypercholesterolaemia in adults who cannot tolerate statin therapy, defined as the presence ofclinically significant adverse effects that represent an unacceptable risk to the patient or that may reduce compliance with therapy.
Ezetimibe, co‑administered with initial statin therapy, is recommended as an option for treating primary (heterozygous‑familial or non‑familial) hypercholesterolaemia in adults who have started statin therapy when:
1. serum total or low‑density lipoprotein (LDL) cholesterol concentration is not appropriately controlled (defined as based on individual risk assessment according to national guidance on managing CV disease in the relevant populations) either after appropriate dose titration of initial statin therapy or because dose titration is limited by intolerance to the initial statin therapy and
2. a change from initial statin therapy to an alternative statin is being considered.
Healthcare professionals should offer adults with FH a referral to a specialist with expertise in FH if treatment with the maximum tolerated dose of a high-intensity statin and ezetimibe does not achieve a recommended reduction in LDL-C concentration of greater than 50% from baseline (that is, LDL-C concentration before treatment).
Local specialist advice is to also consider checking triglyceride levels & consider fibrate.
See NICE CG 71 July 2016 for further information
The ENHANCE study showed the addition of Ezetimibe had no effect on primary or secondary endpoints and emerging evidence contributes to lack of positive cardiovascular outcomes with ezetimibe alone.
|Fibrates||Fenofibrate micronized||160mg tablets: £3.54||Consider use only in severe hypertriglyceridaemia. Do not routinely offer fibrates for the prevention of CVD to any of the following:
• people who are being treated for primary prevention
• people who are being treated for secondary prevention
• people with CKD
• people with type 1 diabetes
• people with type 2 diabetes.
|Nicotinic acid||Specialist recommendation ONLY||These lipid lowering drugs are usually initiated in secondary care by clinical biochemists for patients with complex dyslipidaemias.
Nicotinic acid and bile acid sequestrants : do not use as for fibrates above
|Bile acid sequestrants (Anionic exchange resins)||Colestyramine (Questran®)
|Tredaptive (Nicotinic acid + laropiprant) withdrawn from market Jan 2013. HPS2-THRIVE trial failed to show reduced risk of CV events & incidence of serious adverse events in the treatment group was higher.|
|Omega-3-acid ethyl esters (Omacor®) now non-formulary. NICE MI:secondary prevention (CG172) Nov 2013 says not to offer people omega 3 fatty acid capsules or supplemented foods to prevent another MI. Similarly NICE CG 181 Lipid modification July 2014 does not recommend using omega-3 fatty acids to help prevent CVD|