Περίληψη:
Two proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors,
evolocumab and alirocumab, have recently been approved by both the Food
and Drug Administration (FD A) and the European Medicines Agency (EMA)
for the treatment of hypercholesterolemia. These fully human monoclonal
antibodies selectively block PCSK9, thus permitting the low-density
lipoprotein (LDL) receptor to effectively recycle to the surface of
liver cells. The administration of these antibodies leads to robust LDL
cholesterol (LDL-C) lowering by 50-60% on top of maximum hypolipidemic
treatment. At least 4 randomized, placebo-controlled studies are under
way and will address the question of whether the administration of these
PCSK9 inhibitors is associated with a significant reduction of
cardiovascular events. Because of the high cost associated with the use
of these medications it is very important to consider which patients may
gain the most benefit, at least until the results of outcome studies are
available. In this Consensus paper, 34 clinicians/scientists define 3
groups of patients that should be currently considered as candidates for
the use of these novel drugs. These include: 1a. Adults with established
cardiovascular disease and LDL-C >= 100 mg/dL while on lifestyle
modifications and maximally tolerated hypolipidemic treatment, i.e.
high-intensity statin + ezetimibe, 1b. Adults with diabetes and
established cardiovascular disease or chronic kidney disease or target
organ damage and LDL-C >= 100 mg/dL while on lifestyle modifications and
maximally tolerated hypolipidemic treatment, i.e. high-intensity statin
+ ezetimibe, 2. Adults with familial hypercholesterolemia (FH) without
established cardiovascular disease and LDL-C >= 130 mg/dL while on
lifestyle modifications and maximally tolerated hypolipidemic treatment,
i.e. high-intensity statin + ezetimibe (evolocumab is also indicated in
children above 12 years with homozygous FH), and 3. Adults at high or
very high cardiovascular risk who are statin intolerant and have an
LDL-C >= 100 and >= 130 mg/dL, respectively, while on any tolerated
hypolipidemic treatment.
Συγγραφείς:
Achimastos, Apostolos
Alexandrides, Theodoros
Alexopoulos,
Dimitrios
Athyros, Vasilios
Bargiota, Alexandra
Bilianou,
Eleni
Chrysochoou, Christina
Drogari, Evridiki
Elisaf, Moses
and Ganotakis, Emanouel
Goudevenos, Ioannis
Ioannidis, Ioannis
and Kolovou, Genovefa
Kotsis, Vasilios
Lekakis, Ioannis and
Liberopoulos, Evangelos
Melidonis, Andreas
Nikolaou, Vasilios
and Ntaios, George
Papanas, Nikolaos
Pappas, Stavros and
Pitsavos, Christos
Rallidis, Loukianos
Richter, Dimitrios and
Skoumas, Ioannis
Tentolouris, Nicolaos
Tousoulis, Dimitrios and
Tselepis, Alexandros
Tsioufis, Konstantinos
Tziakas, Dimitrios
and Tziomalos, Konstantinos
Vardas, Panagiotis
Vlachopoulos,
Charalabos
Vlahakos, Dimitrios