Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events

Simple item page
dc.contributor.authorSabatine, Marc S
dc.contributor.authorGiugliano, Robert P
dc.contributor.authorWiviott, Stephen D
dc.contributor.authorRaal, Frederick J
dc.contributor.authorBlom, Dirk J
dc.contributor.authorRobinson, Jennifer
dc.contributor.authorBallantyne, Christie M
dc.contributor.authorSomaratne, Ransi
dc.contributor.authorLegg, Jason
dc.contributor.authorWasserman, Scott M
dc.contributor.authorScott, Robert
dc.contributor.authorKoren, Michael J
dc.contributor.authorStein, Evan A
dc.date.accessioned2021-10-08T07:22:54Z
dc.date.available2021-10-08T07:22:54Z
dc.date.issued2015
dc.description.abstractBACKGROUND: 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. METHODS: 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. RESULTS: 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 neurocognitive events were reported more frequently in the evolocumab group. The risk of adverse events, including neurocognitive events, did not vary significantly according to the achieved level of LDL cholesterol. The rate of cardiovascular events at 1 year was reduced from 2.18% in the standard-therapy group to 0.95% in the evolocumab group (hazard ratio in the evolocumab group, 0.47; 95% confidence interval, 0.28 to 0.78; P=0.003). CONCLUSIONS: During approximately 1 year of therapy, the use of evolocumab plus standard therapy, as compared with standard therapy alone, significantly reduced LDL cholesterol levels and reduced the incidence of cardiovascular events in a prespecified but exploratory analysis. (Funded by Amgen; OSLER-1 and OSLER-2 ClinicalTrials.gov numbers, NCT01439880 and NCT01854918.).
dc.identifier.apacitationSabatine, M. S., Giugliano, R. P., Wiviott, S. D., Raal, F. J., Blom, D. J., Robinson, J., ... Stein, E. A. (2015). Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events. <i>The New England Journal of Medicine</i>, 372(16), 1500 - 1509. http://hdl.handle.net/11427/35022en_ZA
dc.identifier.chicagocitationSabatine, Marc S, Robert P Giugliano, Stephen D Wiviott, Frederick J Raal, Dirk J Blom, Jennifer Robinson, Christie M Ballantyne, et al "Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events." <i>The New England Journal of Medicine</i> 372, 16. (2015): 1500 - 1509. http://hdl.handle.net/11427/35022en_ZA
dc.identifier.citationSabatine, M.S., Giugliano, R.P., Wiviott, S.D., Raal, F.J., Blom, D.J., Robinson, J., Ballantyne, C.M. & Somaratne, R. et al. 2015. Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events. <i>The New England Journal of Medicine.</i> 372(16):1500 - 1509. http://hdl.handle.net/11427/35022en_ZA
dc.identifier.issn0028-4793
dc.identifier.issn1533-4406
dc.identifier.ris TY - Journal Article AU - Sabatine, Marc S AU - Giugliano, Robert P AU - Wiviott, Stephen D AU - Raal, Frederick J AU - Blom, Dirk J AU - Robinson, Jennifer AU - Ballantyne, Christie M AU - Somaratne, Ransi AU - Legg, Jason AU - Wasserman, Scott M AU - Scott, Robert AU - Koren, Michael J AU - Stein, Evan A AB - BACKGROUND: 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. METHODS: 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. RESULTS: 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 neurocognitive events were reported more frequently in the evolocumab group. The risk of adverse events, including neurocognitive events, did not vary significantly according to the achieved level of LDL cholesterol. The rate of cardiovascular events at 1 year was reduced from 2.18% in the standard-therapy group to 0.95% in the evolocumab group (hazard ratio in the evolocumab group, 0.47; 95% confidence interval, 0.28 to 0.78; P=0.003). CONCLUSIONS: During approximately 1 year of therapy, the use of evolocumab plus standard therapy, as compared with standard therapy alone, significantly reduced LDL cholesterol levels and reduced the incidence of cardiovascular events in a prespecified but exploratory analysis. (Funded by Amgen; OSLER-1 and OSLER-2 ClinicalTrials.gov numbers, NCT01439880 and NCT01854918.). DA - 2015 DB - OpenUCT DP - University of Cape Town IS - 16 J1 - The New England Journal of Medicine LK - https://open.uct.ac.za PY - 2015 SM - 0028-4793 SM - 1533-4406 T1 - Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events TI - Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events UR - http://hdl.handle.net/11427/35022 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/35022
dc.identifier.vancouvercitationSabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, et al. Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events. The New England Journal of Medicine. 2015;372(16):1500 - 1509. http://hdl.handle.net/11427/35022.en_ZA
dc.language.isoeng
dc.publisher.departmentDepartment of Medicine
dc.publisher.facultyFaculty of Health Sciences
dc.sourceThe New England Journal of Medicine
dc.source.journalissue16
dc.source.journalvolume372
dc.source.pagination1500 - 1509
dc.source.urihttps://dx.doi.org/10.1056/NEJMoa1500858
dc.subject.otherAged
dc.subject.otherAntibodies, Monoclonal
dc.subject.otherAnticholesteremic Agents
dc.subject.otherCardiovascular Diseases
dc.subject.otherCholesterol, LDL
dc.subject.otherDrug Therapy, Combination
dc.subject.otherFemale
dc.subject.otherHumans
dc.subject.otherHydroxymethylglutaryl-CoA Reductase Inhibitors
dc.subject.otherHypercholesterolemia
dc.subject.otherMale
dc.subject.otherMiddle Aged
dc.subject.otherAntibodies, Monoclonal
dc.subject.otherAnticholesteremic Agents
dc.titleEfficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events
dc.typeJournal Article
uct.type.publicationResearch
uct.type.resourceJournal Article
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
SabatineMarcS_EfficacySafetyE_2015.pdf
Size:
524.13 KB
Format:
Adobe Portable Document Format
Description:
Download
Collections
Journal Articles