1. Expert consensus on the rational clinical use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
- Author
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Evangelos Liberopoulos, George Ntaios, Emanouel Ganotakis, Christos Pitsavos, Apostolos Achimastos, Ioannis Lekakis, Panagiotis Vardas, Loukianos S. Rallidis, Dimitrios Vlahakos, Charalabos Vlachopoulos, Stavros Pappas, Moses Elisaf, Vasilios G. Athyros, Ioannis Ioannidis, Nicolaos Tentolouris, E. Bilianou, Dimitrios Tousoulis, Theodoras Alexandrides, Dimitrios J. Richter, Christina Chrysochoou, Vasilios Nikolaou, Nikolaos Papanas, Ioannis Skoumas, Genovefa Kolovou, Evridiki Drogari, Ioannis Goudevenos, Dimitrios Alexopoulos, Andreas Melidonis, Dimitrios Tziakas, Vasilios Kotsis, Konstantinos Tsioufis, A.D. Tselepis, Alexandra Bargiota, and Konstantinos Tziomalos
- Subjects
Statin ,medicine.drug_class ,Endocrinology, Diabetes and Metabolism ,Hypercholesterolemia ,Familial hypercholesterolemia ,030204 cardiovascular system & hematology ,Pharmacology ,03 medical and health sciences ,0302 clinical medicine ,Ezetimibe ,Diabetes mellitus ,medicine ,Humans ,030212 general & internal medicine ,Hypolipidemic Agents ,Alirocumab ,business.industry ,PCSK9 ,PCSK9 Inhibitors ,General Medicine ,medicine.disease ,Evolocumab ,lipids (amino acids, peptides, and proteins) ,business ,medicine.drug - Abstract
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.
- Published
- 2016
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