Consensus statement of professional associations on prescribing of PCSK9-inhibitors

Česká verzia

Authors: Richard Češka ¹; Miloš Táborský ²; Michal Vrablík ³
Authors place of work: Česká internistická společnost ČLS JEP ¹; Česká kardiologická společnost ²; Česká společnost pro aterosklerózu ³
Published in the journal: AtheroRev 2018; 3(3): 201-207
Category: Guidelines

Summary

A new class of drugs known as PCSK9 inhibitors is designed as biological treatment for hypercholesterolemia. These drugs are administered using a subcutaneous injection once in two or four weeks. PCSK9i ARE NOT a replacement of the existing hypolipidemics, they just expand the therapeutic spectrum for the critically ill and those who cannot use a standard therapy and do not reach satisfactory target values.

Indications are basically two:

hypercholesterolemia and mixed dyslipidemia
secondary prevention of cardiovascular diseases

Statin intolerance is not the only indication for treatment. However as its presence sometimes plays an essential role as to choosing the treatment, it will be also discussed in the paragraph on payment conditions.

Payment conditions: simplified: Treatment will take place at selected centres. A list of the centres forms an annexe to this article. Please find it on the websites www.interna-cz.eu, www.kardio-cz.cz and www.athero.cz.

LDL-C concentration from which prescription of PCSK9i is indicated and covered from public health insurance, is the following:

familial hypercholesterolemia: 4.0 mmol/l
secondary prevention CVD: 3.0 mmol/l

ATTENTION!!!! The presented LDL-C level is one reached under maximum (tolerated) high intensity hypolipidemic therapy. High intensity hypolipidemic therapy is defined as atorvastatin 40–80 mg or rosuvastatin 20–40 mg + ezetimibe.

In the case of demonstrated intolerance of both the mentioned statins the patient has to be treated with a maximum tolerated dose of statins, in combination with another hypolipidemic drug (ezetimibe).

Statin intolerance is defined as intolerance of at least two successive statins, which results in their discontinuation. Statin intolerance alone is not the indication for PCSK9i treatment! The payment criteria must always be complied with.

A medical officer can of course be asked to approve such treatment in exceptional cases.

Key words:

alirocumab, PCSK9 inhibitors centers, center therapy, evolocumab, familial hypercholesterolemia, proprotein konvertase subtilisin/kexin 9 inhibitors (PCSK9i), secondary prevention, statins intolerance

Received: 7. 9. 2018

Zdroje

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