starting statin therapy

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  • exclude secondary causes of hyperlipidaemia e.g. diabetes, hypothyroidism, liver/renal impairment
  • check baseline lipids, liver and renal function, creatine phosphokinase (CK)
  • advise patient regarding medication e.g. adverse effects of statin treatment
  • start statin treatment - statins should be taken in the evening for maximal effect, and require 4 weeks or more to exert their full effect on lipid concentrations
  • LFT should be carried out before and within 4-6 weeks of starting statin therapy (1). Thereafter at intervals of 6 months to 1 year - earlier if clinical features of hepatotoxicity; also at the first review at 4-6 weeks - enquire about adverse effects such as itching, rash, myalgia, arthralgia, insomnia (1)
    • if satisfactory lipid control and no evidence of adverse effects then review again at 4-6 months, then 6-12 monthly
    • if unsatisfactory lipid control then measurements should be repeated 6 weeks after dosage adjustments are made until the desired lipid concentrations are achieved (2)
    • however NICE state that LFTs only need to be measured on three occasions:
      • 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
  • treatment should be discontinued if serum transaminase concentrations rise to, and persist at, 3x normal range
  • patients must be advised to report any unexpected muscle pain. Statins have been associated with the development of myositis, myopathy and myalgia. Some suggest if there is a marked elevation in creatine kinase concentration (>10 times the upper limit of normal) and a diagnosis of myopathy is suspected then the statin therapy should be stopped; however it has also been suggested that if the creatine kinase level is >5x the upper limit of normal then treatment should be stopped, while the patient is adequately monitored for muscular symptoms and cardiovascular risk (4)

Notes:

  • it has been suggested that rather than starting with the lowest licensed dosage, initial dosages of pravastatin (40mg) and simvastatin (20mg) should be used as in published studies (5)
  • the Joint British guidelines suggest that it is common practice to measure baseline CK and alanine/aspartate transaminases (ALT or AST) before starting treatment with a statin as some people may have high values that are physiological, not pathological (6)
  • after initiating treatment with a statin, CK only needs to be checked again if definite unexplained muscle symptoms are reported (6)
  • NICE (7) note that:
    • both total and HDL cholesterol should be measured to achieve the best estimate of CVD risk with Framingham 1991 risk equations
    • before starting lipid modification therapy for primary prevention, people should have at least one fasting lipid sample taken to measure total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
    • people in whom familial hypercholesterolaemia or other monogenic disorders are suspected because of a combination of clinical findings, lipid profiles and family history of premature CHD should be considered for further investigation and specialist review
    • people with severe hyperlipidaemia should be considered for further investigation and/or specialist review
    • with respect to monitoring:
      • if a person taking a statin starts taking additional drugs, or needs treatment for a concomitant illness that interferes with metabolic pathways or increases the propensity for drug and food interactions, consider reducing the dose of the statin, or temporarily or permanently stopping it
      • people who are being treated with 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 - it was noted in the JBS2 guidance that a baseline CK measurement is common practice
      • if a person develops an unexplained peripheral neuropathy, statins should be discontinued and specialist advice sought

Reference:

Last reviewed 01/2018

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