The reduction in MACEs was observed in White but not in Asian subjects .
Both alirocumab and evolocumab are well tolerated and can greatly improve lipid profiles for patients at high cardiovascular risk .
Both PCSK9 monoclonal antibodies significantly reduce the risk of nonfatal MACEs in patients with previous cardiovascular events , but the effect on all-cause mortality remains uncertain
Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) monoclonal antibodies are powerful lipid-lowering drugs which have been shown to improve clinical endpoints in patients with hypercholesterolemia .
However , it is not clear how effective PCSK9 monoclonal antibodies are for patients at high cardiovascular risk .
Also , whether the effectiveness of PCSK9 monoclonal antibodies varies between different drug types , dosages , race , and indications for PCSK9 monoclonal antibodies remains unclear .
Therefore , we used recently published studies to systematic ally evaluate the efficacy and safety of PCSK9 monoclonal antibodies by analyzing the lipid profiles , adverse events , and clinical endpoints in patients at high cardiovascular risk .
A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT).
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 r and omized ( 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
The reduction in MACEs was observed in White but not in Asian subjects .
Both alirocumab and evolocumab are well tolerated and can greatly improve lipid profiles for patients at high cardiovascular risk .
Both PCSK9 monoclonal antibodies significantly reduce the risk of nonfatal MACEs in patients with previous cardiovascular events , but the effect on all-cause mortality remains uncertain
Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) monoclonal antibodies are powerful lipid-lowering drugs which have been shown to improve clinical endpoints in patients with hypercholesterolemia .
However , it is not clear how effective PCSK9 monoclonal antibodies are for patients at high cardiovascular risk .
Also , whether the effectiveness of PCSK9 monoclonal antibodies varies between different drug types , dosages , race , and indications for PCSK9 monoclonal antibodies remains unclear .
Therefore , we used recently published studies to systematic ally evaluate the efficacy and safety of PCSK9 monoclonal antibodies by analyzing the lipid profiles , adverse events , and clinical endpoints in patients at high cardiovascular risk .