1. ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand.
- Author
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Han, Yaling, Chen, Jiyan, Chopra, Vijay Kumar, Zhang, Shuyang, Su, Guohai, Ma, Changsheng, Huang, Zhouqing, Ma, Yingyan, Yao, Zhuhua, Yuan, Zuyi, Zhao, Qiang, Kuanprasert, Srun, Baccara-Dinet, Marie T., Manvelian, Garen, Li, Jianyong, and Chen, Rui
- Subjects
HYPERCHOLESTEREMIA prevention ,CARDIOVASCULAR diseases risk factors ,COMPARATIVE studies ,DRUG tolerance ,DRUG side effects ,LOW density lipoproteins ,MONOCLONAL antibodies ,PATIENT safety ,PROTEOLYTIC enzymes ,RESPIRATORY infections ,STATISTICAL sampling ,TIME ,STATINS (Cardiovascular agents) ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,PRE-tests & post-tests ,EZETIMIBE ,DESCRIPTIVE statistics ,CHEMICAL inhibitors ,PHARMACODYNAMICS ,EVALUATION - Abstract
The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab significantly reduces low-density lipoprotein cholesterol (LDL-C). This study (ODYSSEY EAST) assessed the efficacy and safety of alirocumab vs ezetimibe in high cardiovascular risk patients from Asia. Patients (n = 615) from China, India, and Thailand with hypercholesterolemia at high cardiovascular risk on maximally tolerated statin were randomized (2:1) to alirocumab (75 mg every 2 weeks [Q2W]; with dose increase to 150 mg Q2W at week 12 if week 8 LDL-C was >1.81 mmol/L [>70 mg/dL]) or ezetimibe (10 mg daily) for 24 weeks. The primary efficacy endpoint was percentage change in calculated LDL-C from baseline to week 24. Safety was assessed throughout. Baseline data were similar in both groups. LDL-C levels were reduced from baseline to week 24 by 56.0% and 20.3% in the alirocumab and ezetimibe groups, respectively (P <.0001 vs ezetimibe). Overall, 18.8% of alirocumab-treated patients received a dose increase to 150 mg Q2W. At week 24, 85.1% of alirocumab-treated and 40.5% of ezetimibe-treated patients reached LDL-C <1.81 mmol/L (<70 mg/dL, P <.0001 vs ezetimibe). Treatment-emergent adverse events occurred in 68.5% of alirocumab-treated and 63.1% of ezetimibe-treated patients, with upper respiratory tract infection the most common (alirocumab: 13.3%; ezetimibe: 14.1%). Injection-site reactions occurred more frequently in alirocumab-treated patients (2.7%) than in ezetimibe-treated patients (1.0%). Alirocumab significantly reduced LDL-C vs ezetimibe in high cardiovascular risk patients from Asia and was generally well tolerated. These findings are consistent with previous ODYSSEY studies. • This study evaluated alirocumab in high cardiovascular risk patients from Asia. • Low-density lipoprotein cholesterol (LDL-C) was reduced by 56.0% with alirocumab (P <.0001 vs ezetimibe). • LDL-C <1.81 mmol/L (<70 mg/dL) was reached by 85.1% of alirocumab-treated patients. • Alirocumab was generally well tolerated. • These results are consistent with previous ODYSSEY studies. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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