PMID- 29511875 OWN - NLM STAT- MEDLINE DCOM- 20190403 LR - 20211204 IS - 1534-6242 (Electronic) IS - 1523-3804 (Linking) VI - 20 IP - 4 DP - 2018 Mar 6 TI - Evolocumab: Considerations for the Management of Hyperlipidemia. PG - 17 LID - 10.1007/s11883-018-0720-3 [doi] AB - PURPOSE OF REVIEW: To review the efficacy, safety, pharmacology, and pharmacokinetics of evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. RECENT FINDINGS: PCSK9 inhibitors are a class of lipid-lowering agents that significantly reduce low-density lipoprotein cholesterol (LDL-C) levels in patients with atherosclerotic cardiovascular disease and hyperlipidemia. Evolocumab is a monoclonal antibody that inhibits PCSK9 and has been evaluated in phase II and III studies as monotherapy, in combination with statins and other lipid-lowering therapies, in patients who are statin intolerant, and in patients with heterozygous and homozygous familial hypercholesterolemia. Data from these studies show that evolocumab significantly reduces LDL-C levels. Treatment with evolocumab also significantly improves levels of other lipid parameters (e.g., apolipoproteins A1 and B, lipoprotein(a), non-high-density lipoprotein cholesterol, and triglycerides). Recent results indicate that LDL-C reduction with evolocumab significantly reduces the risk of cardiovascular events and is also associated with atherosclerotic plaque regression. From a safety standpoint, rates of adverse events (AEs), serious AEs, and AEs leading to discontinuation were similar between evolocumab and controls in clinical trials, and no increase in AEs was observed when evolocumab was used in combination with statins. Patients with elevated LDL-C benefit from evolocumab treatment, suggesting that evolocumab could help meet an unmet medical need in high-risk patient populations with atherosclerotic cardiovascular disease and hyperlipidemia that are unable to reduce LDL-C levels sufficiently with statin therapy alone. FAU - Wiggins, Barbara S AU - Wiggins BS AD - Department of Pharmaceutical Sciences, Pharmacy Clinical Specialist-Cardiology, Medical University of South Carolina, Charleston, SC, USA. wiggib@musc.edu. FAU - Senfield, Jeffrey AU - Senfield J AD - Clinical Cardiac Electrophysiologist, Novant Health Heart and Vascular Institute, 1718 East 4th Street, Suite 607, Charlotte, NC, 28204, US. FAU - Kassahun, Helina AU - Kassahun H AD - Clinical Research Medical Director, Amgen Inc., Thousand Oaks, CA, USA. FAU - Lira, Armando AU - Lira A AD - Clinical Research Medical Director, Amgen Inc., Thousand Oaks, CA, USA. FAU - Somaratne, Ransi AU - Somaratne R AD - Global Development Executive Medical Director, Amgen Inc., Thousand Oaks, CA, USA. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20180306 PL - United States TA - Curr Atheroscler Rep JT - Current atherosclerosis reports JID - 100897685 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Anticholesteremic Agents) RN - 0 (PCSK9 Inhibitors) RN - EC 3.4.21.- (PCSK9 protein, human) RN - LKC0U3A8NJ (evolocumab) SB - IM MH - Antibodies, Monoclonal/pharmacokinetics/pharmacology/*therapeutic use MH - Antibodies, Monoclonal, Humanized MH - Anticholesteremic Agents/pharmacokinetics/pharmacology/*therapeutic use MH - Humans MH - Hypercholesterolemia/*drug therapy MH - Hyperlipidemias/drug therapy MH - PCSK9 Inhibitors MH - Risk Factors OTO - NOTNLM OT - Evolocumab OT - Low-density lipoprotein cholesterol OT - PCSK9 OT - Statins EDAT- 2018/03/08 06:00 MHDA- 2019/04/04 06:00 CRDT- 2018/03/08 06:00 PHST- 2018/03/08 06:00 [entrez] PHST- 2018/03/08 06:00 [pubmed] PHST- 2019/04/04 06:00 [medline] AID - 10.1007/s11883-018-0720-3 [pii] AID - 10.1007/s11883-018-0720-3 [doi] PST - epublish SO - Curr Atheroscler Rep. 2018 Mar 6;20(4):17. doi: 10.1007/s11883-018-0720-3.