Is there enough evidence with evolocumab and alirocumab (antibodies to proprotein convertase substilisin-kexin type, PCSK9) on cardiovascular outcomes to use them widely?

Doggrell, Sheila Anne & Lynch, Kaileen Anne (2015) Is there enough evidence with evolocumab and alirocumab (antibodies to proprotein convertase substilisin-kexin type, PCSK9) on cardiovascular outcomes to use them widely? Expert Opinion on Biological Therapy, 15(12), pp. 1671-1675.

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Introduction: Statins alone often do not reduce LDL cholesterol levels sufficiently to given maximum cardiovascular benefit. Thus, additional drugs are required to reduce the levels of LDL cholesterol. Monoclonal antibodies to PCSK9 have recently been shown to decrease LDL cholesterol, but it is not known whether they improve cardiovascular outcomes.

Areas covered: Evaluation of two clinical trials reporting cardiovascular outcomes with antibodies to PCSK9; the OSLER extension with evolocumab and the ODYSSEY LONG TERM trial with alirocumab.

Expert opinion: In OSLER and ODYSSEY LONG TERM, there were very few cardiovascular outcomes, but the trials do suggest that evolocumab and alirocumab may reduce these outcomes. However, there are also some safety concerns with both of these antibodies. Large clinical outcome trials are underway with both evolocumab and alirocumab, which will probably clarify both the safety concerns and any cardiovascular benefits with these antibodies. In our opinion, these antibodies may be suitable for use in subjects with familial hypercholesterolemia, who are uncontrolled with their present medications, provided intensive safety and cardiovascular monitoring is being undertaken. However, evolocumab and alirocumab should be used with caution in other subjects, until outcome studies in higher numbers of subjects, have shown acceptable safety and cardiovascular profiles.

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ID Code: 91560
Item Type: Journal Article
Refereed: Yes
Keywords: LDL cholesterol, alirocumab, cardiovascular events, evolocumab, PCSK9 antibodies
DOI: 10.1517/14712598.2015.1093109
ISSN: 1744-7682
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PHARMACOLOGY AND PHARMACEUTICAL SCIENCES (111500)
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Copyright Owner: Copyright 2015 Taylor & Francis
Copyright Statement: The Version of Record of this manuscript has been published and is available in Expert Opinion on Biological Therapy, 28 September 2015,
Deposited On: 03 Jan 2016 23:04
Last Modified: 07 Jan 2016 05:58

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