Abstract
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.
Highlights
Statins are one of the most widely prescribed medications and the recommended first-line pharmacological therapy for the treatment of hypercholesterolaemia [1]
The occurrence of statin-associated muscle symptoms (SAMS) can have a major negative impact on treatment adherence and, on the prognosis of cardiovascular diseases. Both the European Society of Cardiology (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/European Atherosclerosis Society (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 proprotein convertase subtilisin kexin 9 (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
The US Food and Drugs Administration (FDA) and European Medicines Agency (EMA) have approved the use of PCSK9 inhibitors in the treatment of hypercholesterolaemia if target LDL-C levels could not be reached despite a maximum tolerated statin dose or in the case of intolerance to statins [34]. This decision was based on two trials showing that PCSK9 inhibitors added to maximum tolerated statin doses can further decrease LDL-C by up to 60%; in both trials, the impact of LDL-C reduction appeared to have a statistical impact on clinical events, neither of these trials was designed to measure this [35, 36]
Summary
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, on the prognosis of cardiovascular diseases 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. 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 LDLC under the combination of maximum tolerated stain and ezetimibe
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