|
Table 2: Main clinical studies that evaluated therapy with PCSK9i. |
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|
Study |
FOURIER (2017) |
ODYSSEY outcomes (2018) |
|
Intervention and design |
Evolocumab (either 140 mg every 2 weeks or 420 mg monthly) vs placebo |
Alirocumab subcutaneously 75 mg every 2 weeks vs placebo |
|
|
1:1 randomization with 69% px in high-intensity therapy, 31% moderate or low-intensity, and 5% ezetimibe |
1:1 randomization with 89% px in high-intensity therapy, 8% moderate or low-intensity, and 3% ezetimibe |
|
Patient population |
27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg/dL or higher who were receiving statin therapy |
18,924 patients who had an acute coronary syndrome 1 to 12 months earlier, who were previously under optimal tolerated treatment with high-intensity statins, but with serum levels of non-HDL cholesterol of at least 100 mg/dL, apolipoprotein B of at least 80 mg/dL, or LDL cholesterol of at least 70 mg/dL |
|
Duration |
2.2 years |
2.8 years |
|
Median cholesterol baseline value |
92 mg/dL |
92 ± 31 mg per deciliter |
|
Primary endpoint |
Composite of cardiovascular death, myocardial infarction, stroke, unstable angina that requires hospitalization, or coronary revascularization |
Composite of cardiovascular death, non-fatal myocardial infarction, fatal or nonfatal ischemic stroke, angina that requires hospitalization |
|
Results |
Evolocumab treatment significantly reduced the risk of the primary end point from 11.3% to 9.8% (hazard ratio 0.85; 95% CI; p < 0.001) |
Alirocumab treatment reduced the risk of composite primary end-point event from 11.1% to 9.5% (HR 0.85; 95% CI, 0.78 to 0.93; p < 0.001) |