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Pooled safety analysis of evolocumab in over 6000 patients from double-blind and open-label extension studies

Abstract:
Background—Evolocumab, a fully human monoclonal antibody to PCSK9, markedly reduces LDL-C across diverse patient populations. The objective of this study was to assess the safety and tolerability of evolocumab in a pooled safety analysis from phase 2 or 3 randomized and placebo or comparator-controlled trials (integrated parent trials) and the first year of open-label extension (OLE) trials that included a standard-of-care control group. Methods—This analysi... Expand abstract
Publication status:
Published
Peer review status:
Peer reviewed
Version:
Accepted Manuscript

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Publisher copy:
10.1161/CIRCULATIONAHA.116.025233

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Department:
Oxford, MSD, Nuffield Department of Population Health, Clinical Trial Service Unit
Role:
Author
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Publisher:
American Heart Association Publisher's website
Journal:
Circulation Journal website
Volume:
135
Issue:
19
Pages:
1819-1831
Publication date:
2017-03-01
Acceptance date:
2017-02-16
DOI:
EISSN:
1524-4539
ISSN:
0009-7322
Pubs id:
pubs:684028
URN:
uri:48714894-7e6f-45cb-9bbc-cece787bf865
UUID:
uuid:48714894-7e6f-45cb-9bbc-cece787bf865
Local pid:
pubs:684028
Paper number:
19

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