A study has compared the efficacy [ low-density lipoprotein cholesterol ( LDL-C ) lowering ] and safety of Alirocumab ( Praluent ), a fully human monoclonal antibody to proprotein convertase subtilisin/kexin 9 [ PCSK9 ], compared with Ezetimibe [ Ezetrol, Zetia ] , as add-on therapy to maximally tolerated statin therapy in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia.
COMBO II is a double-blind, double-dummy, active-controlled, parallel-group, 104-week study of Alirocumab versus Ezetimibe.
Patients ( n=720 ) with high cardiovascular risk and elevated LDL-C despite maximal doses of statins were enrolled ( 2012-2013 ).
This pre-specified analysis was conducted after the last patient completed 52 weeks.
Patients were randomized to subcutaneous Alirocumab 75 mg every 2 weeks ( plus oral placebo ) or oral Ezetimibe 10 mg daily ( plus subcutaneous placebo ) on a background of statin therapy.
At Week 24, mean reductions in LDL-C from baseline were 50.6% for Alirocumab versus 20.7% for Ezetimibe ( difference 29.8%; P less than 0.0001 ).
77.0% of Alirocumab and 45.6% of Ezetimibe patients achieved LDL-C less than 1.8 mmol/L ( P less than 0.0001 ). Mean achieved LDL-C at Week 24 was 1.3 mmol/L with Alirocumab and 2.1 mmol/L with Ezetimibe, and were maintained to Week 52.
Alirocumab was generally well tolerated, with no evidence of an excess of treatment-emergent adverse events.
In patients at high cardiovascular risk with inadequately controlled LDL-C, Alirocumab has achieved significantly greater reductions in LDL-C compared with Ezetimibe, with a similar safety profile. ( Xagena )
Cannon CP et al, Eur Heart J 2015; Epub ahead of print