Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the open-label study of long-term evaluation against LDL-C (OSLER) randomized trial
Circulation, Volume 129, No. 2, Year 2014
Notification
URL copied to clipboard!
Description
BACKGROUND-: Evolocumab (AMG 145), a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein cholesterol (LDL-C) in phase 2 studies of 12 weeks' duration. The longer-term efficacy and safety of PCSK9 inhibition remain undefined. METHODS AND RESULTS-: Of 1359 randomized and dosed patients in the 4 evolocumab phase 2 parent studies, 1104 (81%) elected to enroll into the Open-Label Study of Long-term Evaluation Against LDL-C (OSLER) study. Regardless of their treatment assignment in the parent study, patients were randomized 2:1 to receive either open-label subcutaneous evolocumab 420 mg every 4 weeks with standard of care (SOC) (evolocumab+SOC, n=736) or SOC alone (n=368). Ninety-two percent of patients in the evolocumab+SOC group and 89% of patients in the SOC group completed 52 weeks of follow-up. Patients who first received evolocumab in OSLER experienced a mean 52.3% [SE, 1.8%] reduction in LDL-C at week 52 (P<0.0001). Patients who received 1 of 6 dosing regimens of evolocumab in the parent studies and received evolocumab+SOC in OSLER had persistent LDL-C reductions (mean reduction, 50.4% [SE, 0.8%] at the end of the parent study versus 52.1% [SE, 1.0%] at 52 weeks; P=0.31). In patients who discontinued evolocumab on entry into OSLER, LDL-C levels returned to near baseline levels. Adverse events and serious adverse events occurred in 81.4% and 7.1% of the evolocumab+SOC group patients and 73.1% and 6.3% of the SOC group patients, respectively. CONCLUSION-: Evolocumab dosed every 4 weeks demonstrated continued efficacy and encouraging safety and tolerability over 1 year of treatment in the largest and longest evaluation of a PCSK9 inhibitor in hypercholesterolemic patients to date. CLINICAL TRIAL REGISTRATION-: URL: http://clinicaltrials.gov. Unique identifier: NCT01439880. © 2013 American Heart Association, Inc.
Authors & Co-Authors
Koreň, Michael J.
United States, Jacksonville
University Blvd s
Giugliano, Robert P.
United States, Boston
Harvard Medical School
Raal, Frederick Johan
South Africa, Johannesburg
University of the Witwatersrand Faculty of Health Sciences
Sullivan, David R.
Australia, Sydney
Royal Prince Alfred Hospital
Bolognese, Michael A.
United States, Bethesda
Bethesda Health Research Center
Langslet, Gisle
Norway, Oslo
Oslo Universitetssykehus
Civeira, Fernando
Spain, Zaragoza
Hospital Miguel Servet
Somaratne, Ransi M.
United States, Thousand Oaks
Amgen Incorporated
Nelson, Patric
United States, Thousand Oaks
Amgen Incorporated
Liu, Thomas
United States, Thousand Oaks
Amgen Incorporated
Scott, Robert A.
United States, Thousand Oaks
Amgen Incorporated
Wasserman, Scott M.
United States, Thousand Oaks
Amgen Incorporated
Sabatine, Marc S.
United States, Boston
Harvard Medical School
Statistics
Citations: 213
Authors: 13
Affiliations: 8
Identifiers
Doi:
10.1161/CIRCULATIONAHA.113.007012
ISSN:
00097322
e-ISSN:
15244539
Study Design
Cohort Study