TY - JOUR
TI - Expert consensus on the rational clinical use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
AU - Achimastos, A.
AU - Alexandrides, T.
AU - Alexopoulos, D.
AU - Athyros, V.
AU - Bargiota, A.
AU - Bilianou, E.
AU - Chrysochoou, C.
AU - Drogari, E.
AU - Elisaf, M.
AU - Ganotakis, E.
AU - Goudevenos, I.
AU - Ioannidis, I.
AU - Kolovou, G.
AU - Kotsis, V.
AU - Lekakis, I.
AU - Liberopoulos, E.
AU - Melidonis, A.
AU - Nikolaou, V.
AU - Ntaios, G.
AU - Papanas, N.
AU - Pappas, S.
AU - Pitsavos, C.
AU - Rallidis, L.
AU - Richter, D.
AU - Skoumas, I.
AU - Tentolouris, N.
AU - Tousoulis, D.
AU - Tselepis, A.
AU - Tsioufis, K.
AU - Tziakas, D.
AU - Tziomalos, K.
AU - Vardas, P.
AU - Vlachopoulo, C.
AU - Vlahakos, D.
JO - Vitamins and Hormones
PY - 2016
VL - 15
TODO - 1
SP - 8-14
PB - Hellenic Endocrine Society
SN - null
TODO - 10.14310/horm.2002.1659
TODO - alirocumab;  creatine kinase;  evolocumab;  ezetimibe;  hydroxymethylglutaryl coenzyme A reductase inhibitor;  low density lipoprotein cholesterol;  low density lipoprotein receptor;  proprotein convertase subtilisin kexin type 9 inhibitor;  serine proteinase inhibitor;  unclassified drug;  antilipemic agent;  PCSK9 protein, human;  proprotein convertase 9;  alirocumab;  atorvastatin;  evolocumab;  fluindostatin;  mevinolin;  pitavastatin;  pravastatin;  rosuvastatin;  simvastatin, cardiovascular disease;  cardiovascular risk;  cholesterol blood level;  chronic kidney disease;  consensus;  creatine kinase blood level;  diabetes mellitus;  drug contraindication;  drug dose titration;  drug hypersensitivity;  drug indication;  drug tolerance;  drug use;  dyslipidemia;  Editorial;  familial hypercholesterolemia;  high risk patient;  human;  hypercholesterolemia;  lifestyle modification;  low drug dose;  maximum tolerated dose;  monotherapy;  practice guideline;  prescription;  randomized controlled trial (topic);  treatment duration;  antagonists and inhibitors;  Article;  chronic kidney failure;  disease association;  drug industry;  drug tolerability;  familial hypercholesterolemia;  morbidity;  mortality;  practice guideline;  risk factor;  scoring system, Humans;  Hypercholesterolemia;  Hypolipidemic Agents;  Proprotein Convertase 9
TODO - Two proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, evolocumab and alirocumab, have recently been approved by both the Food and Drug Administration (FDA) 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. © 2016, Hellenic Endocrine Society. All rights reserved.
ER -