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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