| Title: |
Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular-risk patients: The ODYSSEY OPTIONS II randomized trial |
| Authors: |
Farnier, M.; Jones, P.; Severance, R.; AVERNA, Maurizio; Steinhagen Thiessen, E.; Colhoun, H.; Du, Y.; Hanotin, C.; Donahue, S. |
| Contributors: |
Farnier, M.; Jones, P.; Severance, R.; Averna, M.; Steinhagen-Thiessen, E.; Colhoun, H.; Du, Y.; Hanotin, C.; Donahue, S. |
| Publisher Information: |
Elsevier Ireland Ltd |
| Publication Year: |
2016 |
| Collection: |
IRIS Università degli Studi di Palermo |
| Subject Terms: |
Alirocumab; Ezetimibe; Low-density lipoprotein cholesterol; Monoclonal antibody; PCSK9; Rosuvastatin; Cardiology and Cardiovascular Medicine; Settore MED/09 - Medicina Interna |
| Description: |
Objective: To compare lipid-lowering efficacy of adding alirocumab to rosuvastatin versus other treatment strategies (NCT01730053). Methods: Patients receiving baseline rosuvastatin regimens (10 or 20 mg) were randomized to: add-on alirocumab 75 mg every-2-weeks (Q2W) (1-mL subcutaneous injection via pre-filled pen); add-on ezetimibe 10 mg/day; or double-dose rosuvastatin. Patients had cardiovascular disease (CVD) and low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL (1.8 mmol/L) or CVD risk factors and LDL-C ≥100 mg/dL (2.6 mmol/L). In the alirocumab group, dose was blindly increased at Week 12 to 150 mg Q2W (also 1-mL volume) in patients not achieving their LDL-C target. Primary endpoint was percent change in calculated LDL-C from baseline to 24 weeks (intent-to-treat). Results: 305 patients were randomized. In the baseline rosuvastatin 10 mg group, significantly greater LDL-C reductions were observed with add-on alirocumab (-50.6%) versus ezetimibe (-14.4%; p < 0.0001) and double-dose rosuvastatin (-16.3%; p < 0.0001). In the baseline rosuvastatin 20 mg group, LDL-C reduction with add-on alirocumab was -36.3% compared with -11.0% with ezetimibe and -15.9% with double-dose rosuvastatin (p = 0.0136 and 0.0453, respectively; pre-specified threshold for significance p < 0.0125). Overall, ~80% alirocumab patients were maintained on 75 mg Q2W. Of alirocumab-treated patients, 84.9% and 66.7% in the baseline rosuvastatin 10 and 20 mg groups, respectively, achieved risk-based LDL-C targets. Treatment-emergent adverse events occurred in 56.3% of alirocumab patients versus 53.5% ezetimibe and 67.3% double-dose rosuvastatin (pooled data). Conclusions: The addition of alirocumab to rosuvastatin provided incremental LDL-C lowering versus adding ezetimibe or doubling the rosuvastatin dose. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/26638010; info:eu-repo/semantics/altIdentifier/wos/WOS:000367375100058; volume:244; firstpage:138; lastpage:146; numberofpages:9; journal:ATHEROSCLEROSIS; http://hdl.handle.net/10447/183606 |
| DOI: |
10.1016/j.atherosclerosis.2015.11.010 |
| Availability: |
http://hdl.handle.net/10447/183606; https://doi.org/10.1016/j.atherosclerosis.2015.11.010 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.D82F24C7 |
| Database: |
BASE |