Efficacy and safety of evolocumab in reducing lipids and cardiovascular events

The New England Journal of Medicine
Marc S SabatineOpen-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators

Abstract

Evolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in short-term studies. We conducted two extension studies to obtain longer-term data. In two open-label, randomized trials, we enrolled 4465 patients who had completed 1 of 12 phase 2 or 3 studies ("parent trials") of evolocumab. Regardless of study-group assignments in the parent trials, eligible patients were randomly assigned in a 2:1 ratio to receive either evolocumab (140 mg every 2 weeks or 420 mg monthly) plus standard therapy or standard therapy alone. Patients were followed for a median of 11.1 months with assessment of lipid levels, safety, and (as a prespecified exploratory analysis) adjudicated cardiovascular events including death, myocardial infarction, unstable angina, coronary revascularization, stroke, transient ischemic attack, and heart failure. Data from the two trials were combined. As compared with standard therapy alone, evolocumab reduced the level of LDL cholesterol by 61%, from a median of 120 mg per deciliter to 48 mg per deciliter (P<0.001). Most adverse events occurred with similar frequency in the two groups, although neurocogn...Continue Reading

References

Mar 24, 2006·The New England Journal of Medicine·Jonathan C CohenHelen H Hobbs
Nov 7, 2007·The New England Journal of Medicine·Philip J BarterUNKNOWN ILLUMINATE Investigators
Jun 30, 2011·European Heart Journal·UNKNOWN European Association for Cardiovascular Prevention & RehabilitationUNKNOWN ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees
Nov 17, 2011·The New England Journal of Medicine·William E BodenWilliam Weintraub
Nov 7, 2012·The New England Journal of Medicine·Gregory G SchwartzUNKNOWN dal-OUTCOMES Investigators
Apr 1, 2014·The New England Journal of Medicine·Dirk J BlomUNKNOWN DESCARTES Investigators
Apr 3, 2014·Journal of the American College of Cardiology·Michael J KorenUNKNOWN MENDEL-2 Investigators
Jul 12, 2014·The New England Journal of Medicine·Martin J LandrayJane Armitage
Nov 30, 2014·Endocrinology and Metabolism Clinics of North America·Evan A Stein, Frederick J Raal

❮ Previous
Next ❯

Citations

Feb 18, 2016·Naunyn-Schmiedeberg's Archives of Pharmacology·Aimo Kannt, Thomas Wieland
Apr 5, 2016·Indian Journal of Endocrinology and Metabolism·Ambika Gopalakrishnan UnnikrishnanAmbrish Mithal
Jan 30, 2016·Expert Opinion on Biological Therapy·Marcos G ValerioWilbert S Aronow
Aug 18, 2016·European Heart Journal. Cardiovascular Pharmacotherapy·Eliano P NavareseMarco Matteo Ciccone
Nov 14, 2015·Expert Review of Cardiovascular Therapy·Michel Farnier
Nov 13, 2015·Expert Opinion on Pharmacotherapy·Maria-Corina SerbanDimitri P Mikhailidis
Aug 22, 2015·Expert Opinion on Drug Metabolism & Toxicology·Michael M Page, Gerald F Watts
Sep 4, 2015·Expert Opinion on Drug Metabolism & Toxicology·Željko Reiner
Nov 14, 2015·Current Medical Research and Opinion·Laurence S Sperling, John R Nelson
Feb 11, 2016·Cardiovascular Drugs and Therapy·Evan A Stein, Frederick Raal
Feb 21, 2016·Cardiovascular Drugs and Therapy·Florian Kronenberg
Dec 15, 2015·European Heart Journal·Baris GencerFrançois Mach
Nov 6, 2015·European Heart Journal·Maarten L Simoons, Jaap W Deckers
Jan 5, 2016·European Heart Journal·M John ChapmanUlf Landmesser
Feb 6, 2016·Cardiovascular Drugs and Therapy·Yanhong GuoY Eugene Chen
Dec 9, 2015·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Gillian M Keating
Jan 6, 2016·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Alan J GarberUNKNOWN American College of Endocrinology (ACE)
Dec 30, 2015·Current Atherosclerosis Reports·Anish Bhatt, Anand Rohatgi
Jan 15, 2016·Nature Reviews. Cardiology·Scott M Grundy
Jan 1, 2016·Lipids in Health and Disease·Maciej BanachAdrian Covic
Dec 23, 2015·PharmacoEconomics·William S Weintraub, Samuel S Gidding
Mar 8, 2016·Journal of Atherosclerosis and Thrombosis·Sang-Hak Lee
Jan 2, 2016·Atherosclerosis·Christina Reith, Jane Armitage
May 12, 2015·Circulation Journal : Official Journal of the Japanese Circulation Society·Toyoaki Murohara
Sep 18, 2015·American Journal of Respiratory Cell and Molecular Biology·Yoshito TakedaIsao Tachibana
Oct 28, 2015·Nature Reviews. Genetics·Andrew R HarperEric J Topol
Mar 18, 2016·Pharmacological Reviews·Philip J Barter, Kerry-Anne Rye
Sep 16, 2015·Current Diabetes Reports·Leah E CahillMajken K Jensen
Mar 24, 2016·Current Cardiology Reports·D P HughesA S Wierzbicki
Oct 13, 2015·BMC Medicine·Robert M StoekenbroekRoeland Huijgen
Mar 31, 2016·European Heart Journal·Jennifer G Robinson
Nov 26, 2015·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Thomas F Whayne
Aug 21, 2015·European Heart Journal·Muh Geot WongVlado Perkovic
Sep 24, 2015·Tidsskrift for den Norske lægeforening : tidsskrift for praktisk medicin, ny række
Sep 2, 2015·Netherlands Heart Journal : Monthly Journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation·E E van der Wall
May 16, 2015·European Heart Journal·William S WeintraubStuart Pocock
Sep 24, 2015·European Heart Journal·Thomas F Lüscher

❮ Previous
Next ❯

Related Concepts

Related Feeds

ApoE, Lipids & Cholesterol

Serum cholesterol, triglycerides, apolipoprotein B (APOB)-containing lipoproteins (very low-density lipoprotein (VLDL), immediate-density lipoprotein (IDL), and low-density lipoprotein (LDL), lipoprotein A (LPA)) and the total cholesterol/high-density lipoprotein (HDL) cholesterol ratio are all connected in diseases. Here is the latest research.