Safety of the PCSK9 inhibitor alirocumab: insights from 47 296 patient-years of observation

European Heart Journal - Cardiovascular Pharmacotherapy

20 April 2024
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ESC Journals Acute Cardiac Care Acute Coronary Syndromes

Abstract

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

Shaun G Goodman
Shaun G Goodman

Author

St. Michael's Hospital Toronto , Canada

Deepak L Bhatt
Deepak L Bhatt

Author

Icahn School of Medicine at Mount Sinai New York City , United States of America

J Wouter Jukema
J Wouter Jukema

Author

Leiden University Medical Center Leiden , Netherlands (The)

Rose Do
Rose Do

Author

Huo Yong
Huo Yong

Author

Wade May
Wade May

Author

Alan Chu
Alan Chu

Author

Kwan Lee
Kwan Lee

Author

Xiang Li
Xiang Li

Author

Lan Cui
Lan Cui

Author

Hong Zhu
Hong Zhu

Author

Biao Xu
Biao Xu

Author

Xi Su
Xi Su

Author

Yi Feng
Yi Feng

Author

Yi Zhong
Yi Zhong

Author

Ying Li
Ying Li

Author

Meng Wei
Meng Wei

Author

Yihua Yu
Yihua Yu

Author

Ying Guo
Ying Guo

Author

Xubo Shi
Xubo Shi

Author

Junbo Ge
Junbo Ge

Author

Feng Bai
Feng Bai

Author

Chun Wu
Chun Wu

Author

Ole May
Ole May

Author

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