SLIDE 15 PCSK9 Outcome Trials
Alirocumab Evolocumab Bococizumab
Trial
ODYSSEY Outcomes (secondary prevention) FOURIER (secondary prevention) SPIRE1 (secondary prevention) SPIRE2 (primary prevention)
No of patients
18000 22500 12000 6300
Dosage
s/c, Q2W s/c, Q2W or Q4W s/c, Q2W s/c, Q2W
Start date
Oct 2012 Jan 2013 Oct 2013 Oct 2013
Expected End date
Mar 2018 Feb 2018 Aug 2017 Aug 2017
Primary endpoint
CHD death
non-fatal MI
fatal and non-fatal ischemic stroke
high risk UA requiring hospitalization
CV death
MI
Stroke
hospitalization for UA
coronary revascularization
CV death
non-fatal MI
non-fatal stroke
hospitalization for UA needing urgent revascularization
CV death
non-fatal MI
non fatal stroke
hospitalization for UA needing urgent revascularization
Duration
Up to Month 64 Up to 5 years Up to Month 60 Up to Month 60
Population
Patients 4 to 52 wks post ACS
LDL-C ≥70 (1.8) History of clinically evident CVD: MI, stroke
and ≥1 major RF or ≥ 2 minor RFs
LDL-C ≥70 (1.8) or High risk patients
LDL-C ≥70 (1.8) and <100 (2.6) or High risk subjects
LDL-C ≥100 (2.6) or