Universität zu Köln

Bays, Harold, Gaudet, Daniel, Weiss, Robert, Ruiz, Juan Lima, Watts, Gerald F., Gouni-Berthold, Ioanna, Robinson, Jennifer, Zhao, Jian, Hanotin, Corinne and Donahue, Stephen (2015). Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial. J. Clin. Endocrinol. Metab., 100 (8). S. 3140 - 3149. WASHINGTON: ENDOCRINE SOC. ISSN 1945-7197

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Abstract

Context: Despite current standard of care, many patients at high risk of cardiovascular disease (CVD) still have elevated low-density lipoprotein cholesterol (LDL-C) levels. Alirocumab is a fully human monoclonal antibody inhibitor of proprotein convertase subtilisin/kexin type 9. Objective: The objective of the study was to compare the LDL-C-lowering efficacy of adding alirocumab vs other common lipid-lowering strategies. Design, Patients, and Interventions: Patients (n = 355) with very high CVD risk and LDL-C levels of 70 mg/dL or greater or high CVD risk and LDL-C of 100 mg/dL or greater on baseline atorvastatin 20 or 40 mg were randomized to one of the following: 1) add-on alirocumab 75 mg every 2 weeks (Q2W) sc; 2) add-on ezetimibe 10 mg/d; 3) double atorvastatin dose; or 4) for atorvastatin 40 mg regimen only, switch to rosuvastatin 40 mg. For patients not achieving protocol-defined LDL-C goals, the alirocumab dose was increased (blinded) at week 12 to 150 mg Q2W. Main Outcome Measure: The primary end point was percentage change in calculated LDL-C from baseline to 24 weeks (intent to treat). Results: Among atorvastatin 20 and 40 mg regimens, respectively, add-on alirocumab reduced LDL-C levels by 44.1% and 54.0% (P < .001 vs all comparators); add-on ezetimibe, 20.5% and 22.6%; doubling of atorvastatin dose, 5.0% and 4.8%; and switching atorvastatin 40 mg to rosuvastatin 40 mg, 21.4%. Most alirocumab-treated patients (87.2% and 84.6%) achieved their LDL-C goals. Most alirocumab-treated patients (86%) maintained their 75-mg Q2W regimen. Treatment-emergent adverse events occurred in 65.4% of alirocumab patients vs 64.4% ezetimibe and 63.8% double atorvastatin/switch to rosuvastatin (data were pooled). Conclusions: Adding alirocumab to atorvastatin provided significantly greater LDL-C reductions vs adding ezetimibe, doubling atorvastatin dose, or switching to rosuvastatin and enabled greater LDL-C goal achievement.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Bays, Harold UNSPECIFIED UNSPECIFIED UNSPECIFIED Gaudet, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Weiss, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruiz, Juan Lima UNSPECIFIED UNSPECIFIED UNSPECIFIED Watts, Gerald F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gouni-Berthold, Ioanna UNSPECIFIED UNSPECIFIED UNSPECIFIED Robinson, Jennifer UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhao, Jian UNSPECIFIED UNSPECIFIED UNSPECIFIED Hanotin, Corinne UNSPECIFIED UNSPECIFIED UNSPECIFIED Donahue, Stephen UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-398137
DOI:	10.1210/jc.2015-1520
Journal or Publication Title:	J. Clin. Endocrinol. Metab.
Volume:	100
Number:	8
Page Range:	S. 3140 - 3149
Date:	2015
Publisher:	ENDOCRINE SOC
Place of Publication:	WASHINGTON
ISSN:	1945-7197
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DENSITY-LIPOPROTEIN CHOLESTEROL; MONOCLONAL-ANTIBODY; EFFICACY; HYPERCHOLESTEROLEMIA; EZETIMIBE; SAFETY; ROSUVASTATIN; PCSK9; THERAPY; METAANALYSIS Multiple languages Endocrinology & Metabolism Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/39813