Recently, the European Society of Cardiology (ESC) and the European
Atherosclerosis Society (EAS) published a consensus paper giving guidance on the definition and management of
statin-associated muscle symptoms (
SAMS), as well as the use of
proprotein convertase subtilisin kexin 9 (
PCSK9) inhibitors in very high-risk patients. The occurrence of
SAMS can have a major negative impact on treatment adherence and, consequently, on the prognosis of
cardiovascular diseases. In addition, both the ESC guidelines on the prevention of
cardiovascular disease (CVD) in clinical practice with sections addressing global strategies to minimise the burden of CVD at population and individual levels, and the 2016 ESC/EAS guideline for the management of dyslipidaemias, focus on evaluation and treatment of
SAMS. The release of these guidelines was a source of great interest to clinicians, as new emergent
therapies, such as the
PCSK9 inhibitors, have been approved for the treatment of dyslipidaemias: recently, both the US Food and Drugs Administration (FDA) and the European Medicines Agency (EMA) approved the use of
PCSK9 inhibitors as add-ons for the treatment of hypercholesterolaemia in cases where
low-density lipoprotein cholesterol (
LDL-C) target levels could not be reached with maximum tolerated
statin doses alone, or instead of
statins in the event of
SAMS. Because of the relatively high cost of these new
therapies, physicians need to justify the use of
PCSK9 inhibitors by demonstrating that their high-risk patients'
LDL-C levels have remained high (1) despite a well-conducted, but insufficiently effective high-intensity
statin therapy (e.g.
rosuvastatin 10-20 mg or
atorvastatin 40-80 mg), or (2) in the event of the patient developing side effects, in particular severe
SAMS, during treatment with at least three
statins. In addition to
SAMS, the use of
PCSK9 inhibitors may be considered in patients with documented atherosclerotic
cardiovascular disease or in patients with familial hypercholesterolaemia and poorly controlled
LDL-C under the combination of maximum tolerated
stain and
ezetimibe.