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Lipid modification - primary and secondary CVD prevention - Management
What follow up is recommended after initiation of statin therapy?

  • Repeat lipid measurement is unnecessary.
    • However, clinical judgement and patient preference should guide the review of drug therapy and whether to review the lipid profile (e.g. to assess compliance).
  • For people taking statins, recheck liver function tests (LFTs) within 3 months of starting treatment, and again at 12 months. Further monitoring is not necessary unless clinically indicated (e.g. symptoms or signs of hepatotoxicity).
  • Monitor for adverse effects of lipid modification therapy:
    • If they develop unexplained muscle symptoms (pain, tenderness, weakness):
      • Check creatine kinase (CK).
      • Stop the lipid-modifying drug immediately if muscle symptoms are severe or if CK is five times or more the upper limit of normal.
      • For further information on managing abnormal CK results with statins, see Raised creatine kinase.
      • Note: people should be advised to seek medical advice and to stop the lipid-modifying drug if they develop unexplained muscle symptoms.
    • For people on a statin:
      • Discontinue the statin and seek specialist advice if they develop unexplained peripheral neuropathy.
      • Advise them to seek medical advice if they develop presenting features of interstitial lung disease such as dyspnoea, non-productive cough, and deterioration in general health (e.g. fatigue, weight loss, and fever).
      • For further information, see Adverse effects.
Clarification / Additional information
  • Statins and other lipid-modifying drugs can rarely cause myopathy and rhabdomyolysis. The exact mechanism is uncertain, but risk factors include [CSM, 2004]:
    • Underlying muscle disorders.
    • Renal impairment.
    • Untreated hypothyroidism.
    • Alcohol abuse.
    • Older age (more than 70 years of age).
    • Concomitant use of other lipid modification therapy (i.e. fibrates, nicotinic acid).
    • A history of myopathy with any lipid modification therapy.
    • Drug interactions (e.g. with drugs inhibiting cytochrome P450 enzymes).
Basis for recommendation
  • These recommendations are based on those issued by the National Institute for Health and Clinical Excellence (NICE) [NICE, 2008a].
  • Repeat lipid measurement:
    • Repeat lipid measurement is unnecessary after initiating a statin or other lipid-modifying drug, because NICE does not recommend a target for total or low-density lipoprotein (LDL) cholesterol for people who are treated with a statin for primary prevention of cardiovascular disease (CVD). For further information, see Lipid targets.
    • However, NICE does not exclude repeat lipid measurement, adding that clinical judgement and patient preference should guide the review of drug therapy and whether to review the lipid profile [NICE, 2008a].
  • Muscular events (rhabdomyolysis and myopathy):
    • These are rare but serious adverse effects of lipid-modifying drugs.
    • The Commission on Human Medicines and NICE advise that people receiving a statin should be asked to report muscle pain, weakness, or cramps immediately and to stop treatment until this has been investigated [CSM, 2004; NICE, 2008a].
    • CKS advises that the same warning should be used for other lipid-modifying drugs (except bile acid sequestrants) because rhabdomyolysis and myopathy have been reported for these drugs and the manufacturers advise similar warnings.
  • Repeat liver function tests:
    • The recommendation to repeat liver function tests within 3 months of starting statin treatment and again at 12 months is based on expert consensus of the NICE Guidance Development Group [NICE, 2008a].
    • Evidence for the monitoring of liver function tests is sparse.
    • Repeat liver function testing is also recommended by other experts [Smellie, 2006; Bhatnagar et al, 2008].
    • CKS did not find any evidence to support the need for long-term monitoring of liver function in people taking a statin (e.g. for more than 12 months).

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