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Table 1 Ongoing clinical outcome trials of PCSK9 inhibitors

From: PCSK9 inhibition: the way forward in the treatment of dyslipidemia

Trial name Study drug Patient population Primary outcome measure Follow-up
FOURIER NCT01764633 Evolocumab n = 27,000; history of CVD – at high risk of recurrent event; LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL; background statin therapy Time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization 5 years
ODYSSEY OUTCOMES NCT01663402 Alirocumab n = 18,000; acute coronary syndrome <52 weeks earlier; LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL; background statin therapy Time to cardiovascular death, non-fatal myocardial infarction, hospitalization for unstable angina, or stroke 64 months
SPIRE-1 NCT01975376 Bococizumab n = 17,000; high risk of CVD event, primary and secondary prevention; background lipid-lowering treatment; LDL-C 70–100 mg/dL or non-HDL-C 100–130 mg/dL Time to composite major cardiovascular event (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina) 60 months
SPIRE-2 NCT01975389 Bococizumab n = 9000; high risk of CVD event; background lipid-lowering treatment; LDL-C ≥100 mg/dL or non-HDL-C ≥130 mg/dL Time to composite major cardiovascular event (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina) 60 months
  1. CVD Cardiovascular disease, HDL-C High-density lipoprotein cholesterol, LDL-C Low-density lipoprotein cholesterol