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 .
Efficacy and safety of alirocumab in insulin‐treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM‐INSULIN randomized trial
Aims To investigate the efficacy and safety of alirocumab in participants with type 2 ( T2D ) or type 1 diabetes ( T1D ) treated with insulin who have elevated LDL cholesterol levels despite maximally tolerated statin therapy . Methods Participants at high cardiovascular risk with T2D ( n = 441 ) or T1D ( n = 76 ) and LDL cholesterol levels ≥1.8 mmol/L ( ≥70 mg/dL ) were r and omized 2:1  to alirocumab : placebo administered subcutaneously every 2 weeks , for 24 weeks ' double‐blind treatment . Alirocumab‐treated participants received 75 mg every 2 weeks , with blinded dose increase to 150 mg every 2 weeks at week 12 if week 8 LDL cholesterol levels were ≥1.8 mmol/L. Primary endpoints were percentage change in calculated LDL cholesterol from baseline to week 24 , and safety assessment s. Results Alirocumab  reduced LDL cholesterol from baseline to week 24 by a mean ± st and ard error of 49.0 % ± 2.7 % and 47.8 % ± 6.5 % vs placebo ( both P < .0001 ) in participants with T2D and T1D , respectively . Significant reductions were observed in non‐HDL cholesterol ( P < .0001 ) , apolipoprotein B ( P < .0001 ) and lipoprotein ( a ) ( P ≤ .0039 ) . At week 24 , 76.4 % and 70.2 % of the alirocumab group achieved LDL cholesterol < 1.8 mmol/L in the T2D and T1D population s ( P < .0001 ) , respectively . Glycated haemoglobin and fasting plasma glucose levels remained stable for the study duration . Treatment‐emergent adverse events were observed in 64.5 % of alirocumab‐ vs 64.1 % of placebo‐treated individuals ( overall population ) . Conclusions Alirocumab  produced significant LDL cholesterol reductions in participants with insulin‐treated diabetes regardless of diabetes type , and was generally well tolerated . Concomitant administration of alirocumab and insulin did not raise any safety concerns ( NCT02585778 )
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 .