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2.12 Lipid regulating drugs

2.12 Lipid regulating drugs

2.12 Lipid regulating drugs


        Useful documents:  
             > Summary of National Guidance for Lipid Management for Primary and Secondary Prevention of Cardiovascular Disease    
             > Stain Intolerance Pathway  
             > NICE CG181 Cardiovascular disease: risk assessment and reduction, including lipid modification  
   

      2.12 Lipid regulating drugs

         Drug therapy should be combined with dietary control. Statins should be prescribed in line with NICE guidance CG181.
         This guideline updates and replaces the previous NICE guideline on lipid modification (CG67) . It offers 
         evidence-based advice on the care and treatment of people at risk of cardiovascular disease and people who have had
         previous cardiovascular disease.
 
         A summary flow chart for cardiovascular risk assessment and the modification of blood lipids for the primary
        and secondary prevention of cardiovascular disease in East Lancashire is available here [under review]
 
        Atorvastatin is now the first line agent – see lipid modification guidelines before prescribing
        Statins
        First line  
        GREEN      Generic Atorvastatin tablets 10mg, 20mg, 40mg, 80mg
        GREEN      Simvastatin tablets 20mg, 40mg  
        GREEN      Pravastatin tablets 20mg, 40mg  
        GREEN      Rosuvastatin 5mg, 10mg, 20mg
 
        Simvastatin and Atorvastatin are associated with some significant drug-drug interactions
        The table below provides information and advice on managing these interactions.

Interacting drug or food  

Simvastatin prescribing  advice      

Atorvastatin prescribing advice  

Potent CYP3A4 inhibitors, including:  itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, and HIV protease inhibitors. 

All are contraindicated with simvastatin. 

Avoid if possible: consider temporary suspension of atorvastatin if interacting drug is taken for short period.                       Itraconazole: do not exceed 40mg atorvastatin daily.                               Clarithromycin: do not exceed 20mg atorvastatin daily.                  HIV protease inhibitors: monitor lipid levels to ensure lowest necessary dose of atorvastatin is used. 

Ciclosporin* 

Contraindicated with simvastatin. 

Do not exceed 10mg generic atorvastatin daily. 

Danazol 

Contra-indicated with simvastatin.  

No restriction in Summary of Product Characteristics. 

Verapamil, amiodarone. 

Do not exceed 20mg simvastatin daily.  

Monitor lipid levels to ensure lowest necessary dose of atorvastatin is used. 

Diltiazem 

Do not exceed 20mg simvastatin daily.  

Monitor lipid levels to ensure lowest necessary dose of atorvastatin is used.  

Amlodipine Do not exceed 20mg simvastatin daily Monitor lipid levels to ensure lowest necessary dose of generic atorvastatin is used.  

Grapefruit juice 

Avoid grapefruit juice. 

Limit intake of grapefruit juice to very small quantities (or avoid altogether). 

Warfarin/courmarins† 

Monitor INR before starting treatment and regularly during treatment, especially with dose changes. 

Monitor INR before starting treatment and regularly during treatment, especially with dose changes.  

Fibrates† 

Increased risk of myopathy when used with fibrates; do not exceed 10mg simvastatin daily (except with fenofibrate); gemfibrozil increases systemic exposure to simvastatin. 

Increased risk of myopathy when used with fibrates; gemfibrozil increases systemic exposure to atorvastatin. 

Ezetimibe† 

Additive risk of myopathy cannot be ruled out. 

Additive risk of myopathy cannot be ruled out.  


        *Ciclosporin interacts with all statins and is contraindicated with rosuvastatin. 
         †Warfarin/courmarins, fibrates and ezetimibe are important potential interactions to consider for all statins.
 
        Intolerance of statins   
         Please see Statin Intolerance Pathway 
         If a person is not able to tolerate a high‑intensity statin aim to treat with the maximum tolerated dose. Tell the person that  
         any statin at any dose reduces CVD risk. If someone reports adverse effects when taking high‑intensity statins discuss the 
         following possible strategies with them:   
               >     stopping the statin and trying again when the symptoms have resolved to check if the symptoms are related to the
                      statin
               >     reducing the dose within the same intensity group.
               >     changing the statin to a lower intensity group.
               >     Seek specialist advice about options for treating people at high risk of CVD such as those with CKD, type 1 diabetes,  
                      type 2 diabetes or genetic dyslipidaemias, and those with CVD, who are intolerant to 3 different statins.
 
         Fibrates in CVD -updated in line with NICE CG181  
         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 

        GREEN       Fenofibrate (Supralip®) tablets 160mg 

     
  Ezetimibe             
        People with primary hypercholesterolaemia should be considered for exetimibe treatment in line with Ezetimibe        
        for treating primary heterozygous-familial and non-familial hypercholesterolaemia as per NICE TA358 (replaces NICE           
        TAG132)  
        GREEN      Ezetimibe tablets 10mg


AMBER      Bempedoic acid with ezetimibe [Nustendi®, Nilemdo®]
        This recommendation does not apply to bempedoic acid when used without ezetimibe.
        NICE TA694 Recommended as an option for treating primary hypercholesterolaemia (heterozygous familial and non-familial)
                            or mixed dyslipidaemia as an adjunct to diet in adults. It is recommended only if:
                                > statins are contraindicated or not tolerated.
                                > ezetimibe alone does not control low-density lipoprotein cholesterol well enough, and
                                > the company provides bempedoic acid and bempedoic acid with ezetimibe according to the 
                                   commercial arrangement
                             Bempedoic acid with ezetimibe can be used as separate tablets or a fixed-dose combination.
                             Suitable for GP prescribing following recommendation/initiation by specialist.                          CCG commissioned


Alirocumab (NICE TAG393) and Evolocumab (NICE TAG394) are recommended as options  for treating primary
        hypercholesterolaemia or mixed dyslipidaemia
 
        RED          Alirocumab (Praluent®)   Solution for injection 75mg/mL, 150mg/ml                                          (CCG commissioned)  
        RED          Evolocumab (Repatha®)  


GREEN RESTRICTED     Inclisiran    - see position statement                                                                    CCG commissioned
To be used in accordance with the 'Summary of National Guidance for Lipid Management for Primary and Secondary Prevention of CVD'
       NICE TA733 Inclisiran is recommended as an option for treating primary hypercholesterolaemia (heterozygous familial and 
                           non-familial) or mixed dyslipidaemia as an adjunct to diet in adults. It is recommended only if:
                                   > there is a history of any of the following cardiovascular events:
                                          º acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation)
                                          º coronary or other arterial revascularisation procedures
                                          º coronary heart disease
                                          º ischaemic stroke or
                                          º peripheral arterial disease, and 
                                  > low-density lipoprotein cholesterol (LDL-C) concentrations are persistently 2.6 mmol/l or more, despite 
                                     maximum tolerated lipid-lowering therapy, that is:
                                          º maximum tolerated statins with or without other lipid-lowering therapies or,
                                          º other lipid-lowering therapies when statins are not tolerated or are contraindicated, and
                                  > the company provides inclisiran according to the commercial arrangement.
 

GREEN   Icosapent ethyl [Vazkepa]
NICE TA805   Icosapent ethyl is recommended as an option for reducing the risk of cardiovascular events in adults.
                       It is recommended if they have a high risk of cardiovascular events and raised fasting triglycerides (1.7 mmol/litre or 
                       above) and are taking statins, but only if they have:
                           > established cardiovascular disease (secondary prevention), defined as a history of any of the following:
                                  - acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation)
                                  - coronary or other arterial revascularisation procedures 
                                  - coronary heart disease
                                  - ischaemic stroke
                                  - peripheral arterial disease, and
                           > low-density lipoprotein cholesterol (LDL‑C) levels above 1.04 mmol/litre and below or equal to 2.60 mmol/litre.
See full NICE guidance                                                                                                                 ICB Commissioned   
 
       
Nicotinic acid group  
        Do not offer nicotinic acid (niacin) for the prevention of CVD to any of the following:  
 
        Omega-3-acid ethyl esters   
        BLACK        Omega-3-acid ethyl esters - Post Myocardial Infarction.  
        NHS England has identified this product as an item that should not be routinely prescribed in primary care. Available to 
        purchase over the counter. Click herefor the  Position Statement for Omega-3-acid ethyl ester prescribing in CVD  
        BLACK        Omega-3 fatty acid compounds for preventing CVD   
        NHS England has identified this product as an item that should not be routinely prescribed in primary care. Available to 
        purchase over the counter.
 
        Recommendations in this section update and replace recommendations 1.10.4.1 and 1.10.4.2 from Type 2 diabetes 
        (NICE clinical guideline 87).  
        Do not offer omega‑3 fatty acid compounds 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
         There is no evidence that omega‑3 fatty acid compounds help to prevent CVD
 
        Omega-3-acid ethyl esters - Hypertriglyceridaemia   
        NHS England has identified this product as an item that should not be routinely prescribed in primary care. Available to 
        purchase  over the counter.
        BLACK      Omega-3-acid ethyl ester capsules 1g.   
 
        Anion-exchange resins  
        Do not offer a bile acid sequestrant (anion exchange resin) 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
 
        Combination therapy for preventing CVD 
        Do not offer the combination of a bile acid sequestrant (anion exchange resin), fibrate, nicotinic acid or omega-3 fatty acid 
        compound with a statin for the primary or secondary prevention of CVD. 
 
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