title: Role of PCSK9 antibodies in cardiovascular disease: Critical considerations of mortality and neurocognitive findings from the current literature.
abstract: Monoclonal antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) are a novel lipid-lowering approach found to improve clinical outcomes in patients with dyslipidemia. With coronary artery disease remaining the most frequent cause of morbidity and mortality worldwide, a drug offering a true mortality reduction should be appropriately regarded as a novel blockbuster in cardiovascular medicine, provided that significant side effects do not emerge. However, a recent study may suggest an increase of neurocognitive adverse events with those drugs. A critical overview of current evidence on neurocognitive outcomes as well as the meta-analytical approach with open-label extension trials evaluating PCSK9 monoclonal antibodies is needed to avoid potential controversy.
authors.affiliation: Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network, Germany; Collegium Medicum in Bydgoszcz, University of Nicolaus Copernicus, Toruń, Poland.
authors.forename: Michalina
authors.initials: M
authors.lastname: Kołodziejczak
authors.affiliation: Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network, Germany; Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Düsseldorf, Germany. Electronic address: elianonavarese@gmail.com.
authors.forename: Eliano P
authors.initials: EP
authors.lastname: Navarese
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D015415:Biomarkers / Q000097:blood; D002318:Cardiovascular Diseases / Q000097:blood / Q000401:mortality / Q000517:prevention & control*; D003071:Cognition / Q000187:drug effects*; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy* / Q000201:enzymology / Q000401:mortality; D019317:Evidence-Based Medicine; D006801:Humans; D000960:Hypolipidemic Agents / Q000009:adverse effects*; D008055:Lipids / Q000097:blood*; D019965:Neurocognitive Disorders / Q000139:chemically induced* / Q000175:diagnosis / Q000401:mortality / Q000523:psychology; D000091362:PCSK9 Inhibitors; D000071449:Proprotein Convertase 9 / Q000276:immunology; D018570:Risk Assessment; D012307:Risk Factors
chemical_list: D000911:Antibodies, Monoclonal; D015415:Biomarkers; D000960:Hypolipidemic Agents; D008055:Lipids; D000091362:PCSK9 Inhibitors; C472125:PCSK9 protein, human; D000071449:Proprotein Convertase 9
keywords: Meta-analysis; Mortality; Neurocognitive effects; PCSK9 antibodies