Safety of the PCSK9 inhibitor alirocumab: insights from 47 296 patient-years of observation
European Heart Journal - Cardiovascular Pharmacotherapy
Abstract
The ODYSSEY OUTCOMES trial, comprising over 47 000 patient-years of placebo-controlled observation, demonstrated important reductions in the risk of recurrent ischaemic cardiovascular events with the monoclonal antibody to proprotein convertase subtilisin/kexin type 9 alirocumab, as well as lower all-cause death. These benefits were observed in the context of substantial and persistent lowering of low-density lipoprotein cholesterol with alirocumab compared with that achieved with placebo. The safety profile of alirocumab was indistinguishable from matching placebo except for a ∼1.7% absolute increase in local injection site reactions. Further, the safety of alirocumab compared with placebo was evident in vulnerable groups identified before randomization, such as the elderly and those with diabetes mellitus, previous ischaemic stroke, or chronic kidney disease. The frequency of adverse events and laboratory-based abnormalities was generally similar to that in placebo-treated patients. Thus, alirocumab appears to be a safe and effective lipid-modifying treatment over a duration of at least 5 years.
Contributors
Naresh K Goyal
Author
Philippe Gabriel Steg
Author
Rituparna Shinde
Author
Gajendra V Manakshe
Author
Michael Szarek
Author
Nitin Patki
Author
Brack Hattler
Author
Rose Do
Author
Chad Link
Author
Sumeet Sethi
Author
Anna Bortnick
Author
George Kinzfogl
Author
Arnold Ghitis
Author
Deepak L Bhatt
Author
Icahn School of Medicine at Mount Sinai New York City , United States of America
Vengatesh Munusamy
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Sunil Karnaand Sunil Thanvi
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Srilakshmi Adhyapak
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Chandrakant Patil
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Ulhas Pandurangi
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Rishabh Mathur
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Jugal Gupta
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Suhas Kalashetti
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Ajit Bhagwat
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John Larry
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Vera A Bittner
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Edward Teufel
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Peter Kuhlman
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Bagirath Raghuraman
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Brent Mclaurin
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Rafael Diaz
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Wenwu Zhang
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Robert A Harrington
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Stephen Thew
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Jalal Abbas
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Matthew White
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Harvey D White
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Shiv Kumar Yerra
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Andreas M Zeiher
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Othman Islam
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Prasant Bhansali
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Sumeet Subherwal
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Nandkishore Ranadive
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Garen Manvelian
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Rohidas Borse
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Robert Pordy
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Yann Poulouin
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Babak Vakili
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Patil Rahul
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Wanda Stipek
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Christian Gring
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David Henderson
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Srihari Das
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Genevieve Garon
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Gregory G Schwartz
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Gregory G Schwartz
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Vinay Kumar
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Timothy Schuchard
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Ph Gabriel Steg
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Jabir Abdullakutty
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Shireesh Saathe
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Naim Farhat
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Priya Palimkar
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Geoffrey Kline
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Deepak L Bhatt
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Sharan Mahal
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Jack Whitaker
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