Effect of Alirocumab on Lipoprotein(a) Over ≥1.5 Years (from the Phase 3 ODYSSEY Program)

Daniel Gaudet; Gerald F Watts; Jennifer G Robinson; Pascal Minini; William J Sasiela; Jay Edelberg; Michael J Louie; Frederick J Raal

doi:10.1016/j.amjcard.2016.09.010

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Effect of Alirocumab on Lipoprotein(a) Over ≥1.5 Years (from the Phase 3 ODYSSEY Program)

Journal article

Open access

Peer reviewed

Effect of Alirocumab on Lipoprotein(a) Over ≥1.5 Years (from the Phase 3 ODYSSEY Program)

Daniel Gaudet, Gerald F Watts, Jennifer G Robinson, Pascal Minini, William J Sasiela, Jay Edelberg, Michael J Louie and Frederick J Raal

The American journal of cardiology, Vol.119(1), pp.40-46

01/01/2017

DOI: 10.1016/j.amjcard.2016.09.010

PMID: 27793396

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Abstract

Elevated lipoprotein(a) [Lp(a)] is independently associated with increased cardiovascular risk. However, treatment options for elevated Lp(a) are limited. Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9, reduced low-density lipoprotein cholesterol (LDL-C) by up to 62% from baseline in phase 3 studies, with adverse event rates similar between alirocumab and controls. We evaluated the effect of alirocumab on serum Lp(a) using pooled data from the phase 3 ODYSSEY program: 4,915 patients with hypercholesterolemia from 10 phase 3 studies were included. Eight studies evaluated alirocumab 75 mg every 2 weeks (Q2W), with possible increase to 150 mg Q2W at week 12 depending on LDL-C at week 8 (75/150 mg Q2W); the other 2 studies evaluated alirocumab 150-mg Q2W from the outset. Comparators were placebo or ezetimibe. Eight studies were conducted on a background of statins, and 2 studies were carried out with no statins. Alirocumab was associated with significant reductions in Lp(a), regardless of starting dose and use of concomitant statins. At week 24, reductions from baseline were 23% to 27% with alirocumab 75/150-mg Q2W and 29% with alirocumab 150-mg Q2W (all comparisons p <0.0001 vs controls). Reductions were sustained over 78 to 104 weeks. Lp(a) reductions with alirocumab were independent of race, gender, presence of familial hypercholesterolemia, baseline Lp(a), and LDL-C concentrations, or use of statins. In conclusion, in addition to marked reduction in LDL-C, alirocumab leads to a significant and sustained lowering of Lp(a).

Double-Blind Method

Humans

Middle Aged

Ezetimibe

Antibodies, Monoclonal - therapeutic use

Male

Treatment Outcome

Hypercholesterolemia - drug therapy

Lipoprotein(a) - drug effects

Anticholesteremic Agents - therapeutic use

Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use

Endpoint Determination

Female

Drug Therapy, Combination

Details

Title: Subtitle: Effect of Alirocumab on Lipoprotein(a) Over ≥1.5 Years (from the Phase 3 ODYSSEY Program)
Creators: Daniel Gaudet - Department of Medicine, ECOGENE-21 Clinical and Translational Research Center and Lipidology Unit, Université de Montréal, Chicoutimi, Quebec, Canada. Electronic address: daniel.gaudet@umontreal.ca
Gerald F Watts - Lipid Disorders Clinic, Centre for Cardiovascular Medicine, Royal Perth Hospital, School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia
Jennifer G Robinson - University of Iowa, Iowa City, Iowa
Pascal Minini - Biostatistics and Programming, Sanofi, Chilly-Mazarin, France
William J Sasiela - Regeneron Pharmaceuticals, Inc., Tarrytown, New York
Jay Edelberg - Sanofi, Bridgewater, New Jersey
Michael J Louie - Regeneron Pharmaceuticals, Inc., Tarrytown, New York
Frederick J Raal - Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa
Resource Type: Journal article
Publication Details: The American journal of cardiology, Vol.119(1), pp.40-46
DOI: 10.1016/j.amjcard.2016.09.010
PMID: 27793396
NLM abbreviation: Am J Cardiol
ISSN: 0002-9149
eISSN: 1879-1913
Publisher: United States
Language: English
Date published: 01/01/2017
Academic Unit: Epidemiology; Internal Medicine
Record Identifier: 9983995163302771

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