Efficacy and Safety of Alirocumab as Add-on Therapy in High-Cardiovascular-Risk Patients With Hypercholesterolemia Not Adequately Controlled With Atorvastatin (20 or 40 mg) or Rosuvastatin (10 or 20 mg): Design and Rationale of the ODYSSEY OPTIONS Studies

被引:38
|
作者
Robinson, Jennifer G. [1 ,2 ]
Colhoun, Helen M. [3 ]
Bays, Harold E. [4 ]
Jones, Peter H. [5 ]
Du, Yunling [6 ]
Hanotin, Corinne [8 ]
Donahue, Stephen [7 ]
机构
[1] Univ Iowa, Coll Publ Hlth, Dept Epidemiol, Iowa City, IA 52242 USA
[2] Univ Iowa, Coll Publ Hlth, Dept Med, Iowa City, IA 52242 USA
[3] Univ Dundee, Sch Med, Div Populat Hlth Sci, Dundee, Scotland
[4] Louisville Metab & Atherosclerosis Res Ctr, Louisville, KY USA
[5] Baylor Coll Med, Clin Studies Unit, Houston, TX 77030 USA
[6] Regeneron Pharmaceut Inc, Dept Biostat, Tarrytown, NY 10591 USA
[7] Regeneron Pharmaceut Inc, Dept Clin Sci, Tarrytown, NY 10591 USA
[8] Sanofi, Dept Clin Res, Paris, France
关键词
DENSITY-LIPOPROTEIN CHOLESTEROL; FAMILIAL HYPERCHOLESTEROLEMIA; MONOCLONAL-ANTIBODY; LOWERING TREATMENT; STATIN THERAPY; LDL-C; PREVENTION; DISEASE; GUIDELINES; METAANALYSIS;
D O I
10.1002/clc.22327
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
The phase 3 ODYSSEY OPTIONS studies (OPTIONS I, NCT01730040; OPTIONS II, NCT01730053) are multicenter, multinational, randomized, double-blind, active-comparator, 24-week studies evaluating the efficacy and safety of alirocumab, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, as add-on therapy in approximate to 650 high-cardiovascular (CV)-risk patients whose low-density lipoprotein cholesterol (LDL-C) levels are 100 mg/dL or 70 mg/dL according to the CV-risk category, high and very high CV risk, respectively, with atorvastatin (20-40 mg/d) or rosuvastatin (10-20 mg/d). Patients are randomized to receive alirocumab 75 mg via a single, subcutaneous, 1-mL injection by prefilled pen every 2 weeks (Q2W) as add-on therapy to atorvastatin (20-40 mg) or rosuvastatin (10-20 mg); or to receive ezetimibe 10 mg/d as add-on therapy to statin; or to receive statin up-titration; or to switch from atorvastatin to rosuvastatin (OPTIONS I only). At week 12, based on week 8 LDL-C levels, the alirocumab dose may be increased from 75 mg to 150 mg Q2W if LDL-C levels remain 100 mg/dL or 70 mg/dL in patients with high or very high CV risk, respectively. The primary efficacy endpoint in both studies is difference in percent change in calculated LDL-C from baseline to week 24 in the alirocumab vs control arms. The studies may provide guidance to inform clinical decision-making when patients with CV risk require additional lipid-lowering therapy to further reduce LDL-C levels. The flexibility of the alirocumab dosing regimen allows for individualized therapy based on the degree of LDL-C reduction required to achieve the desired LDL-C level.
引用
收藏
页码:597 / 604
页数:8
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