Alirocumab for hyperlipidemia: ODYSSEY Phase III clinical trial results and US FDA approval indications

Future Cardiology
Eli M Roth

Abstract

A new class of lipid-lowering drugs, inhibitors of PCSK9 has been generating impressive clinical trial data over the last several years, and alirocumab (Praluent) has become the first to be approved by the US FDA. Alirocumab has been shown to lower low density lipoprotein cholesterol by 45-62% with a safety profile generally comparable to placebo. Alirocumab is a monoclonal antibody to PCSK9 administered subcutaneously and has been evaluated in 16 Phase III clinical trials, the majority of which have been enrolled or completed. This article will be a review of the available Phase III safety and efficacy data of the ODYSSEY studies including a brief description of each of the 16 studies.

References

Nov 2, 2012·The New England Journal of Medicine·Eli M RothEvan A Stein
Mar 17, 2015·The New England Journal of Medicine·Jennifer G RobinsonUNKNOWN ODYSSEY LONG TERM Investigators
Jun 2, 2015·The Journal of Clinical Endocrinology and Metabolism·Harold BaysStephen Donahue
Jun 4, 2015·The New England Journal of Medicine·Christopher P CannonUNKNOWN IMPROVE-IT Investigators

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Citations

Oct 13, 2016·The American Journal of Cardiology·Peter H JonesJennifer G Robinson
Aug 31, 2016·Annual Review of Pharmacology and Toxicology·Amy C BurkeMurray W Huff
Mar 10, 2017·Expert Opinion on Biological Therapy·Brian TomlinsonZhong-Min Liu
Oct 11, 2017·Expert Opinion on Drug Safety·Eli M Roth
Jul 25, 2019·Circulation. Cardiovascular Quality and Outcomes·Kelly D MyersDaniel J Rader
Aug 11, 2020·Expert Opinion on Pharmacotherapy·Brian TomlinsonChristopher Wai Kei Lam
Jun 14, 2018·Clinical Science·Allison B ReissJoshua DeLeon

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Clinical Trials Mentioned

NCT01617655
NCT01507831
NCT01623115
NCT01709500
NCT01644175
NCT01644188
NCT01730040
NCT01730053
NCT01709513
NCT01644474

Software Mentioned

ODYSSEY

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