Ongoing trials of PCSK9 inhibitors
| Trial | Drug | Primary outcome | No. patients | Expected completion | LDL-C on background therapy (mg/dL) |
|---|---|---|---|---|---|
| FOURIER53 | Evolocumab | Time to CV death, MI, hospitalization for UA, stroke, or coronary revascularization | 27,500 | 2016–2017 | > 70 |
| ODYSSEY54 | Alirocumab | Time to CV death, nonfatal MI, hospitalization for UA, stroke | 18,000 | 2017 | > 70 |
| SPIRE-1,55 SPIRE-256 | Bococizumab | Time to composite major CV event (CV death, nonfatal MI, nonfatal stroke, and hospitalization for UA) | 26,000 | 2017–2018 | 70–99 SPIRE-1 > 100 SPIRE-2 |
CV = cardiovascular; FOURIER = Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk; LDL-C = low-density-lipoprotein cholesterol; MI = myocardial infarction; ODYSSEY OUTCOMES = Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; SPIRE-1, SPIRE-2 = The Evaluation of Bococizumab in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects; UA = unstable angina