Despite current standard-of-care, many patients at high cardiovascular disease ( CVD ) risk still have elevated low-density lipoprotein cholesterol ( LDL-C ).
Alirocumab ( Praluent ) is a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 ( PCSK9 ).
The aim of ODYSSEY OPTIONS I trial was to compare LDL-C-lowering efficacy of adding Alirocumab vs other common lipid-lowering strategies.
Patients ( n=355 ) with cardiovascular disease and LDL cholesterol levels greater than or equal to 70 mg/dL, or cardiovascular disease risk factors and LDL cholesterol gretaer than or equal to 100 mg/dL, on baseline Atorvastatin ( Lipitor ) 20 or 40 mg, were randomized to: (1) add-on Alirocumab 75 mg every 2 weeks ( Q2W ) subcutaneously; (2) add-on Ezetimibe ( Zetia ) 10 mg/day; (3) double Atorvastatin dose; (4) for Atorvastatin 40 mg regimen only, switch to Rosuvastatin ( Crestor ) 40 mg.
For patients not achieving protocol-defined LDL cholesterol goals, Alirocumab dose was increased ( blinded ) at week 12 to 150 mg Q2W.
Primary endpoint was % change in calculated LDL cholesterol from baseline to 24 weeks ( intent-to-treat ).
Among Atorvastatin 20 and 40 mg regimens respectively, add-on Alirocumab reduced LDL-C levels by 44.1% and 54.0% ( p less than 0.001 vs all comparators ); add-on Ezetimibe, 20.5% and 22.6%; doubling of Atorvastatin dose, 5.0% and 4.8%; and switching Atorvastatin 40 mg to Rosuvastatin 40 mg, 21.4%.
Most Alirocumab-treated patients ( 87.2% and 84.6% ) achieved their LDL cholesterol goals.
Most Alirocumab-treated patients ( 86% ) maintained their 75 mg Q2W regimen.
Treatment-emergent adverse events occurred in 65.4% of Alirocumab patients, vs 64.4% Ezetimibe and 63.8% double Atorvastatin / switch to Rosuvastatin ( data pooled ).
In conclusion, adding Alirocumab to Atorvastatin provided significantly greater LDL cholesterol reductions versus adding Ezetimibe, doubling Atorvastatin dose, or switching to Rosuvastatin, and enabled greater LDL cholesterol goal achievement. ( Xagena )
Bays H, J Clin Endocrinol Metab 2015; Epub ahead of print