Author + information
- Kwang K. Koha,b,
- Chang-Wook Nama,b,
- Ting-Hsing Chaoa,b,
- Ming-En Liua,b,
- Chiung-Jen Wua,b,
- Dong-Soo Kima,b,
- Chong-Jin Kima,b,
- Ivy Lia,b,
- Jianyong Lia,b,
- Marie Baccara-Dineta,b,
- Pi-Jung Hsiaoa,b and
- Chern-En Chianga,b
Background: Alirocumab (ALI), a fully human monoclonal antibody to PCSK9, has been shown to provide significant reductions in LDL-C. Data about its efficacy and safety in patients from South Korea and Taiwan is limited.
Methods: Patients (n=199) with hypercholesterolemia at high cardiovascular risk who were on maximally tolerated statin in South Korea and Taiwan were randomized (1:1) to ALI (75 mg every 2 weeks [Q2W]; with dose increase to 150 mg Q2W at Week 12 if LDL-C ≥70 mg/dL at Week 8) or placebo (PBO) for 24 weeks. The primary efficacy endpoint was percentage change in calculated LDL-C from baseline to Week 24. Safety was assessed throughout.
Results: Baseline data were similar in both treatment groups (Table). At Week 24, ALI changed LDL-C levels by −57.1% (PBO: +6.3%). In the ALI group, 9 patients (9.5%) received dose increase at Week 12. At Week 24, 85.8% of patients in the ALI group reached LDL-C <70 mg/dL (PBO: 14.2%; P<0.0001 vs PBO). Data for secondary lipid parameters are shown in the Table. Two consecutive calculated LDL-C values <25 mg/dL were recorded in 27 (27.8%) ALI-treated patients. Overall, 58.8% (ALI) and 61.8% (PBO) experienced treatment-emergent adverse events (TEAE); 2.1% and 1.0% discontinued the study due to TEAE, respectively.
Conclusions: ALI significantly reduced LDL-C, apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein (a) and total cholesterol in Asian patients. ALI was generally well tolerated. These findings are consistent with ODYSSEY findings to date.
Moderated Poster Contributions
Prevention Moderated Poster Theater, Poster Hall, Hall C
Friday, March 17, 2017, 11:30 a.m.-11:40 a.m.
Session Title: The PCSK9 Revolution: New Insights Into Evaluation and Treatment
Abstract Category: 32. Prevention: Clinical
Presentation Number: 1133M-15
- 2017 American College of Cardiology Foundation