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PCSK9 Inhibitors in cardiovascular prevention for all type of patients, clinical trials results

alirocumab versus ezetimibe (on top statin)
ODYSSEY OPTIONS I,
Alirocumab 75 mg with potential up-titration to 150 mg Q2W
versus
Ezetimibe 10 mg
high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg)
Follow-up duration: 24 wk
ODYSSEY OPTIONS II,
Alirocumab 75 mg with potential up-titration to 150 mg Q2W
versus
Ezetimibe 10 mg
high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg)
Follow-up duration: 24 wk
alirocumab versus ezetimibe alone
ODYSSEY MONO,
NCT01644474
Alirocumab 75 mg Q2W
versus
Ezetimibe 10 mg
hypercholesterolemic patients at moderate cardiovascular risk not receiving statins or other lipid-lowering therapydouble-blind
Follow-up duration: 24 wk
alirocumab versus placebo (on top statins)
ODYSSEY Alternative,
NCT01709513
Alirocumab 75 mg with potential up-titration to 150 mg Q2W
versus
Ezetimibe 10 mg
statin-intolerant patientsdouble-blind
Follow-up duration: 24 wk
ODYSSEY COMBO,
NCT01644175
Alirocumab 75 mg with potential up-titration to 150 mg Q2W
versus
Placebo
high cardiovascular risk patients on maximally tolerated statin therapydouble-blind
Follow-up duration: 52 wk
ODYSSEY COMBO II,
NCT01644188
Alirocumab 75 mg with potential up-titration to 150 mg Q2W
versus
Ezetimibe 10 mg
high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statinsdouble-blind
Follow-up duration: 104 wk
ODYSSEY FH 1,
NCT01623115
Alirocumab 75 mg with potential up-titration to 150 mg Q2W
versus
Placebo
patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapydouble-blind
Follow-up duration: 78 wk
ODYSSEY FH 2,
NCT01709500
Alirocumab 75 mg with potential up-titration to 150 mg Q2W
versus
Placebo
patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapydouble blind
Follow-up duration: 78 wk
ODYSSEY HIGH FH ,
NCT01617655
Alirocumab 150 mg Q2W
versus
Placebo
patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy
Follow-up duration: 52–78 wk
ODYSSEY Long-Term, 2015
NCT01507831
alirocumab 150 mg as a 1-ml subcutaneous injection every 2 weeks for 78 weeks.
versus
placebo
patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or more and were receiving treatment with statins at the maximum tolerated dose (the highest dose associated with an acceptable side-effect profile), with or without other lipid-lowering therapy
Follow-up duration: 78 wk
ODYSSEY OUTCOMES, 2018
NCT01663402
Alirocumab (on top intensive or maximum-tolerated statin therapy)
versus
placebo
Post-ACS patients (1 to 12 months)with elevated levels of atherogenic lipoproteins despite intensive or maximum-tolerated statin therapydouble-blind
Follow-up duration: 2.8 yr (median)
57 countries
evolocumab versus ezetimibe alone
GAUSS 2,
NCT01763905
evolocumab 140 mg every two weeks (Q2W) or evolocumab 420 mg once monthly (QM)
versus
ezetimibe 10 mg
patients with statin intolerance
evolocumab versus placebo
GAUSS 1, 2012
NCT01375764

versus
statin-intolerant patients
evolocumab versus placebo (on top statins)
DESCARTES, 2014
NCT01516879
evolocumab (420 mg) every 4 weeks
versus
placebo

Follow-up duration: 52 weeks
FOURIER, 2017
NCT01764633
evolocumab (either 140 mg every 2 weeks or 420 mg monthly)
versus
placebo
patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapydouble-blind
Follow-up duration: 2.2 years
LAPLACE 2, 2014
NCT01763866
evolucumab + statin
versus
placebo + statin
LAPLACE-TIMI 57,
NCT01380730
subcutaneous injections of AMG 145 70 mg, 105 mg, or 140 mg,
versus
placebo
RUTHERFORD-1,
NCT01375751
AMG 145 350 mg, AMG 145 420 mg
versus
placebo
heterozygous familial hypercholesterolemia patients
RUTHERFORD-2, 2015
NCT01763918
subcutaneous evolocumab 140 mg every 2 weeks, evolocumab 420 mg monthly
versus
placebo
heterozygous familial hypercholesterolaemia

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