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. Author manuscript; available in PMC: 2016 Apr 1.
Published in final edited form as: Curr Opin Endocrinol Diabetes Obes. 2015 Apr;22(2):126–132. doi: 10.1097/MED.0000000000000137

Table 1.

Ongoing phase 3 clinical trials using monoclonal antibodies against proprotein convertase subtilisin/kexin 9

Monoclonal antibody used Evolocumab by Amgen Alirocumab by Sanofi/Regeneron Bococizumab by Pfizer
Phase 3 trial FOURIER ODYSSEY outcome SPIRE I/II
Enrollment (n) 22 500 18 000 17 000/9000
Inclusion criteria Age 40–85, History of CVD with high risk of recurrent event, LDL-c >70 mg/dl, triglycerides <400 mg/dl Age >40, hospitalized of Acute Coronary Syndrome in the last 52 weeks before enrollment, LDL-c >70 mg/dl I – Age >18, background of lipid-lowering treatment, at high risk of a cardiovascular event, LDL 70–100 mg/dl
II – Age >18, background of lipid lowering treatment, at high risk of a cardiovascular event, LDL >100 mg/dl
Subcutaneous injection intervals Once every 2 weeks Once every 2 weeks
End date 02.2018 03.2018 06.2018/03.2018

FOURIER, Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk; LDL, low-density lipoprotein; ODYSSEY; SPIRE, The Evaluation Of PF-04950615 (RN316), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects.