COMBO II Flashcards
Who was the main author in COMBO II ?
Cannon C P et al.
Where and when was its published ?
European Heart Journal 2015
What was the objective of COMBO II
Efficacy & Safety of Alirocumab in cardiovascular in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on max tolerated dose of statins.
How many pts were included in the study ?
720 patients
What was the Inclusion criteria of COMBO II ?
Pts over 18yrs old at high CV risk not adequately controlled hypercholesterolaemia.
What were the end points in COMBO II?
Primary: % change in LDL-C level from baseline at week 24.
2nd Endpoint: other lipoproteins at week 24
Safety endpoint: AE reports and lab analyses
What were the baseline characteristics?
CHD: 90%
Type 2 Diabetes 30%
ON statins: All but one
High dose statin: 67%
What was the baseline LDL-C ?
2.8 mmol/l
What was the LDL-C reduction at week 24 ?
50.6% vs 20.7% for Ezetimibe
At week 24 what % of Praluent treated pts. achieved their LDL-C target of less than 1.8 mmol/l ?
77% vs 45% in the Ezetimibe group.
What was the dose of Ezetimibe given ?
10 mg daily plus SC placebo every 2 weeks.
At week 8 what % of Praluent treated pts. achieved their LDL-C target of less than 1.8 mmol/l ?
80% achieved pre-specified target LDL-C of less than 1.8 mmol/l
The overall % of pts. who experienced one treatment TEAE ?
Praluent: 72%
Ezetimibe: 67%
TEAE leading to death ?
Praluent: 0.4%( N=2)
Ezetimibe: 1.7% (N=4)
