Kwang Kon Koh1, Chang Wook Nam2, Ting-Hsing Chao3, Ming-En Liu4, Chiung-Jen Wu5, Dong-Soo Kim6, Chong-Jin Kim7, Ivy Li8, Jianyong Li9, Marie T Baccara-Dinet10, Pi-Jung Hsiao11, Chern-En Chiang12. 1. Gachon University Gil Medical Center, Incheon, Korea. 2. Keimyung University Dongsan Medical Center, Daegu, South Korea. 3. Department of Internal Medicine, College of Medicine and Hospital, National Cheng Kung University, Tainan City, Taiwan. 4. Division of Cardiology, Department of Internal Medicine, Hsinchu Mackay Memorial Hospital, Hsinchu, Taiwan. 5. Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, Tao-Yuan City, Taiwan. 6. Inje University Busan Paik Hospital, Busan, Korea. 7. Kyung Hee University Hospital at Gangdong, Seoul, Korea. 8. Sanofi R&D, Beijing, China. 9. Sanofi R&D, Shanghai, China. 10. Sanofi R&D, Montpellier, France. 11. Division of Endocrinology and Metabolism, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan. Electronic address: pjhsiao@cc.kmu.edu.tw. 12. General Clinical Research Center, Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.
Abstract
BACKGROUND:Alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, has been shown to provide significant reductions in low-density lipoprotein cholesterol (LDL-C). Data about its efficacy and safety in patients from South Korea and Taiwan are limited. OBJECTIVE: ODYSSEY KT assessed the efficacy and safety of alirocumab in patients from South Korea and Taiwan. METHODS:Patients with hypercholesterolemia at high cardiovascular risk who were on maximally tolerated statin were randomized (1:1) to alirocumab (75 mg every 2 weeks, with dose increase to 150 mg every 2 weeks at week 12 if LDL-C ≥70 mg/dL at week 8) or placebo for 24 weeks. The primary efficacy endpoint was percentage change in LDL-C from baseline to week 24. Safety was assessed throughout. RESULTS: At week 24, alirocumab changed LDL-C levels by -57.1% (placebo: +6.3%). In the alirocumab group, 9 patients (9.5%) received dose increase at week 12. At week 24, 85.8% of patients in the alirocumab group reached LDL-C <70 mg/dL (placebo: 14.2%; P ≤ .0001 vs placebo). Alirocumab significantly improved non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B, total cholesterol, lipoprotein (a), and HDL-C vs placebo (P ≤ .05). Two consecutive calculated LDL-C values <25 mg/dL were recorded in 27.8% of alirocumab-treated patients. Overall, 58.8% (alirocumab) and 61.8% (placebo) of patients experienced treatment-emergent adverse events; 2.1% and 1.0% discontinued treatment due to treatment-emergent adverse events, respectively. CONCLUSION:Alirocumab significantly improved LDL-C, apolipoprotein B, non-HDL-C, lipoprotein (a), HDL-C, and total cholesterol in Asian patients. Alirocumab was generally well tolerated. These findings are consistent with ODYSSEY findings to date.
RCT Entities:
BACKGROUND:Alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, has been shown to provide significant reductions in low-density lipoprotein cholesterol (LDL-C). Data about its efficacy and safety in patients from South Korea and Taiwan are limited. OBJECTIVE: ODYSSEY KT assessed the efficacy and safety of alirocumab in patients from South Korea and Taiwan. METHODS:Patients with hypercholesterolemia at high cardiovascular risk who were on maximally tolerated statin were randomized (1:1) to alirocumab (75 mg every 2 weeks, with dose increase to 150 mg every 2 weeks at week 12 if LDL-C ≥70 mg/dL at week 8) or placebo for 24 weeks. The primary efficacy endpoint was percentage change in LDL-C from baseline to week 24. Safety was assessed throughout. RESULTS: At week 24, alirocumab changed LDL-C levels by -57.1% (placebo: +6.3%). In the alirocumab group, 9 patients (9.5%) received dose increase at week 12. At week 24, 85.8% of patients in the alirocumab group reached LDL-C <70 mg/dL (placebo: 14.2%; P ≤ .0001 vs placebo). Alirocumab significantly improved non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B, total cholesterol, lipoprotein (a), and HDL-C vs placebo (P ≤ .05). Two consecutive calculated LDL-C values <25 mg/dL were recorded in 27.8% of alirocumab-treated patients. Overall, 58.8% (alirocumab) and 61.8% (placebo) of patients experienced treatment-emergent adverse events; 2.1% and 1.0% discontinued treatment due to treatment-emergent adverse events, respectively. CONCLUSION:Alirocumab significantly improved LDL-C, apolipoprotein B, non-HDL-C, lipoprotein (a), HDL-C, and total cholesterol in Asian patients. Alirocumab was generally well tolerated. These findings are consistent with ODYSSEY findings to date.
Authors: Amand F Schmidt; John-Paul L Carter; Lucy S Pearce; John T Wilkins; John P Overington; Aroon D Hingorani; J P Casas Journal: Cochrane Database Syst Rev Date: 2020-10-20
Authors: Yundai Chen; Zuyi Yuan; Juming Lu; Freddy G Eliaschewitz; Alberto J Lorenzatti; Maria Laura Monsalvo; Nan Wang; Andrew W Hamer; Junbo Ge Journal: Diabetes Obes Metab Date: 2019-04-14 Impact factor: 6.577