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Towards companion diagnostics for the management of statin therapy.

BACKGROUND
Statins are the most commonly prescribed drugs in the world and are established first-line therapy for cardiovascular disease. Statin toxicity is related to dose, age, gender, ethnicity, body mass, renal and endocrine function and also to concomitant medications - particularly those that inhibit cytochrome P450 3A4.


OBJECTIVE/METHOD
This review describes the tests used before initiation of statin therapy, to establish their efficacy and to monitor their principal side effects. Lipids and apolipoproteins are used to measure efficacy and compliance, whereas transaminases and creatine kinase are used to measure toxicity. Guidelines agree in general, but differ in the details of measurement of baseline levels, action limits and management strategies for statin toxicity. Genetic factors are relevant to both the efficacy and the toxicity of statin therapy, with efficacy being associated with polymorphisms in lipid-related genes, whereas a function-related polymorphism in the organic anion transporting polypeptide 1B1 (OATP1B1; SLCO1B1) is associated with 60% of the cases of myopathy with high-dose simvastatin.


CONCLUSIONS
Although basic efficacy and safety panels for the initiation and monitoring of statin therapy are well established, controversy remains about the need for ancillary diagnostics in patients and to which patient groups these should be applied.