Treatment with a PCSK9 inhibitor is well tolerated and improves cardiovascular outcomes .
Although no overall benefit was noted in all-cause or cardiovascular mortality , such benefit may be achievable in patients with higher baseline low-density lipoprotein cholesterol
BACKGROUND We sought to examine the efficacy and safety of 2 PCSK9 ( proprotein convertase subtilisin/kexin type 9 ) inhibitors : alirocumab and evolocumab .
Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular-risk patients: The ODYSSEY OPTIONS II randomized trial.
OBJECTIVE To compare lipid-lowering efficacy of adding alirocumab to rosuvastatin versus other treatment strategies ( NCT01730053 ) . METHODS Patients receiving baseline rosuvastatin regimens ( 10 or 20 mg ) were r and omized to :  add-on alirocumab 75 mg every-2-weeks ( Q2W ) ( 1-mL subcutaneous injection via pre-filled pen ) ; add-on ezetimibe 10 mg/day ; or double-dose rosuvastatin .  Patients had cardiovascular disease ( CVD ) and low-density lipoprotein cholesterol ( LDL-C ) ≥70 mg/dL ( 1.8 mmol/L ) or CVD risk factors and LDL-C ≥100 mg/dL ( 2.6 mmol/L ) . In the alirocumab group , dose was blindly increased at Week 12 to 150 mg Q2W ( also 1-mL volume ) in patients not achieving their LDL-C target . Primary endpoint was percent change in calculated LDL-C from baseline to 24 weeks ( intent-to-treat ) . RESULTS 305 patients were r and omized . In the baseline rosuvastatin 10 mg group , significantly greater LDL-C reductions were observed with add-on alirocumab ( -50.6 % ) versus ezetimibe ( -14.4 % ; p < 0.0001 ) and double-dose rosuvastatin ( -16.3 % ; p < 0.0001 ) . In the baseline rosuvastatin 20 mg group , LDL-C reduction with add-on alirocumab was -36.3 % compared with -11.0 % with ezetimibe and -15.9 % with double-dose rosuvastatin ( p = 0.0136 and 0.0453 , respectively ; pre-specified threshold for significance p < 0.0125 ) . Overall , ∼80 % alirocumab patients were maintained on 75 mg Q2W . Of alirocumab-treated patients , 84.9 % and 66.7 % in the baseline rosuvastatin 10 and 20 mg groups , respectively , achieved risk-based LDL-C targets . Treatment-emergent adverse events occurred in 56.3 % of alirocumab patients versus 53.5 % ezetimibe and 67.3 % double-dose rosuvastatin ( pooled data ) . CONCLUSIONS The addition of alirocumab to rosuvastatin provided incremental LDL-C lowering versus adding ezetimibe or doubling the rosuvastatin dose
Treatment with a PCSK9 inhibitor is well tolerated and improves cardiovascular outcomes .
Although no overall benefit was noted in all-cause or cardiovascular mortality , such benefit may be achievable in patients with higher baseline low-density lipoprotein cholesterol
BACKGROUND We sought to examine the efficacy and safety of 2 PCSK9 ( proprotein convertase subtilisin/kexin type 9 ) inhibitors : alirocumab and evolocumab .