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Lipid modification - primary and secondary CVD prevention - Management
What monitoring is recommended when prescribing a statin?

  • Before initiating a statin:
    • Measure baseline liver enzymes (transaminases):
      • Do not initiate a statin if transaminase levels are three or more times the upper limit of normal:
      • People with liver enzymes (transaminases) that are elevated but are less than three times the upper limit of normal should not be routinely excluded from statin therapy.
    • Check creatine kinase if the person is at high risk of muscle toxicity. This is not routinely necessary in other people.
  • After initiating a statin:
    • Repeat liver function tests (LFTs) within 3 months of starting treatment, again at 12 months, and after each dose increase, but not again unless clinically indicated (e.g. signs or symptoms of hepatotoxicity):
    • Check creatine kinase as soon as possible if the person reports muscular symptoms (rhabdomyolysis and myopathy are rare but serious adverse effects of statins):
Clarification / Additional information
  • Pretreatment baseline creatine kinase:
    • The Scottish Intercollegiate Guidelines Network recommends pretreatment baseline creatine kinase measurement for people at high risk of muscle toxicity (e.g. older individuals or when combining a statin with a drug known to increase myotoxicity) [SIGN, 2007].
    • The manufacturer of simvastatin recommends that this should be checked in people with predisposing factors for rhabdomyolysis [ABPI Medicines Compendium, 2009]:
      • Elderly (more than 70 years of age).
      • Renal impairment.
      • Uncontrolled hypothyroidism.
      • Personal or familial history of hereditary muscular disorders.
      • History of muscular toxicity with a statin or fibrate.
      • Alcohol abuse.
Basis for recommendation
  • These recommendations are based on guidance issued by the National Institute for Health and Clinical Excellence (NICE), the Scottish Intercollegiate Guidelines Network (SIGN), and expert opinion [Smellie et al, 2005; Smellie, 2006; SIGN, 2007; NICE, 2008a].
  • Pretreatment baseline creatine kinase (CK) only for people at high risk of experiencing muscle toxicity:
    • NICE does not make any recommendation regarding the need for pretreatment, baseline CK measurement [NICE, 2008a].
    • This recommendation is based on that from SIGN [SIGN, 2007], following the consensus recommendations issued by the National Lipid Association Statin Safety Task Force [McKenney et al, 2006; SIGN, 2007]. This US group reviewed evidence from the US Food and Drug Administration (FDA), cohort and clinical trials, and administrative claims database information. Four of its expert panels assessed statin safety with regard to liver, muscle, renal, and neurological systems.
    • This recommendation is consistent with the manufacturer of simvastatin which recommends that CK should be measured in people with predisposing factors for rhabdomyolysis [ABPI Medicines Compendium, 2009].
  • Repeat liver function tests (LFTs):
    • The recommendation to repeat LFTs within 3 months of starting statin treatment and again at 12 months is based on the expert consensus of the NICE Guidance Development Group [NICE, 2008a]. Evidence for the monitoring of LFTs is sparse.
    • CKS did not find any evidence to support the need for long-term monitoring of liver function in people taking statins (for more than 12 months).
    • The recommendation to repeat LFTs after a dose increase is also based on expert opinion [Smellie et al, 2005; Smellie, 2006].

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