Korean J Intern Med.  2019 Nov;34(6):1252-1262. 10.3904/kjim.2018.133.

Efficacy and safety of alirocumab in Korean patients with hypercholesterolemia and high cardiovascular risk: subanalysis of the ODYSSEY-KT study

• Nam CW
• Kim DS
• Li J
• Baccara-Dinet MT
• Li I
• Kim JH
• Kim CJ

• KMID: 2463483
• DOI: http://doi.org/10.3904/kjim.2018.133

Abstract

BACKGROUND/AIMS
Efficacy and safety data of alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), is not yet well established in the Korean population. We assessed them in ODYSSEY-KT through the pre-specified Korean subanalysis.
METHODS
In the ODYSSEY-KT study, South Korean and Taiwanese patients with hypercholesterolemia and high cardiovascular risks were randomized (1:1) to alirocumab or placebo. Alirocumab was self-administered subcutaneously at 75 mg every 2 weeks with a maximally tolerated statin dose with or without other lipid-modifying therapies. Alirocumab dose was increased to 150 mg every 2 weeks at week 12 if low density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL at week 8. Primary endpoint was percent change in LDL-C from baseline to week 24. Results from Korean cohort (n = 83: 40 for alirocumab and 43 for placebo, respectively) analyses are reported here.
RESULTS
In alirocumab group, the least square of mean change percent in LDL-C levels was -65.7% (placebo: 11.1%; p < 0.0001) and 92.0% of them achieved LDL-C < 70 mg/dL (placebo: 12.7%; p < 0.0001) at week 24. Alirocumab also showed significantly greater improvements in high density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol, lipoprotein(a), and apolipoprotein B than placebo (p < 0.05). Two consecutive calculated LDL-C values < 25 mg/dL were observed in 37.5% of alirocumab-treated patients. Overall, 45.0% alirocumab-treated and 51.2% placebo-treated patients experienced treatment-emergent adverse events (TEAEs) without discontinuation of treatment due to TEAEs.
CONCLUSIONS
Alirocumab has demonstrated to be effective in improvement of LDL-C and related lipid profiles in Korean cohort. Alirocumab was generally well tolerated with no significant safety signals.

Keyword

PCSK9; Cholesterol, LDL; ODYSSEY; Hypercholesterolemia

MeSH Terms

Apolipoproteins
Cholesterol
Cholesterol, HDL
Cholesterol, LDL
Cohort Studies
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypercholesterolemia*
Lipoprotein(a)
Proprotein Convertases
Apolipoproteins
Cholesterol
Cholesterol, HDL
Cholesterol, LDL
Lipoprotein(a)
Proprotein Convertases