- The dose of Alirocumab was adjusted under blinded conditions to target an LDLc 25-50 mg/dL.
Primary endpoint was a composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.
RESULTS
The median duration of follow-up was 2.8 years.
- A composite primary endpoint event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (HR 0.85, p<0.001).
- A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died (HR, 0.85, p<0.05).
- The absolute benefit of Alirocumab with respect to the composite primary endpoint was greater among patients who had a baseline LDLc ≥100 mg/dL than among patients who had a lower baseline level.
The incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the alirocumab group vs. 2.1% in the placebo group).
CONCLUSIONS
Among patients who had a previous ACS and who were receiving high-intensity statin therapy, the risk of recurrent ischemic CVEs was lower among those who received alirocumab than among those who received placebo.
- High-intensity dose or
- Maximum tolerated dose.
Patients were randomly assigned to receive Alirocumab subQ at a dose of 75 mg (9462 patients) or matching placebo (9462 patients) every 2 weeks.
- The dose of Alirocumab was adjusted under blinded conditions to target an LDLc 25-50 mg/dL.
Primary endpoint was a composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.
RESULTS
The median duration of follow-up was 2.8 years.
- A composite primary endpoint event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (HR 0.85, p<0.001).
- A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died (HR, 0.85, p<0.05).
- The absolute benefit of Alirocumab with respect to the composite primary endpoint was greater among patients who had a baseline LDLc ≥100 mg/dL than among patients who had a lower baseline level.
The incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the alirocumab group vs. 2.1% in the placebo group).
CONCLUSIONS
Among patients who had a previous ACS and who were receiving high-intensity statin therapy, the risk of recurrent ischemic CVEs was lower among those who received alirocumab than among those who received placebo.
In ODYSSEY trial, the addition of PCSK9 inhibitor, Alirocumab to high-intensity statin further reduced cardiovascular events by 15% in patients with very-high baseline CVD risk (prior ACS) and elevated atherogenic cholesterol particles. Atherogenicity was defined by LDLc ≥70 mg/dL, non-HDLc ≥100 mg/dL, or Apo B ≥80 mg/dL.
About 19,000 patients with acute coronary syndrome 1-12 months prior to study initiation were followed for 3 years. The study target was final LDLc between 25-50 mg/dL. Similar to FOURIER 2017 results, ODYSSEY 2018 adds more evidence to the notion “the lower the LDLc, the lower ASCVD events”
GT
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N E J M
Odyssey
November 2018
BACKGROUND
Patients who have had an acute coronary syndrome (ACS) are at high risk for recurrent ischemic cardiovascular events. We sought to determine whether alirocumab, a human monoclonal antibody to proprotein convertase subtilisin–kexin type 9 (PCSK9), would improve cardiovascular outcomes after an ACS in patients receiving high-intensity statin therapy.
METHODS
We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 18,924 patients who had:
- ACS 1-12 months earlier
- LDLc ≥70 mg/dL
- non-HDLc ≥100 mg/d, or
- Apo B ≥80 mg/dL
- Were receiving statin therapy at
- High-intensity dose or
- Maximum tolerated dose.
Patients were randomly assigned to receive Alirocumab subQ at a dose of 75 mg (9462 patients) or matching placebo (9462 patients) every 2 weeks.
- The dose of Alirocumab was adjusted under blinded conditions to target an LDLc 25-50 mg/dL.
Primary endpoint was a composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.
RESULTS
The median duration of follow-up was 2.8 years.
- A composite primary endpoint event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (HR 0.85, p<0.001).
- A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died (HR, 0.85, p<0.05).
- The absolute benefit of Alirocumab with respect to the composite primary endpoint was greater among patients who had a baseline LDLc ≥100 mg/dL than among patients who had a lower baseline level.
The incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the alirocumab group vs. 2.1% in the placebo group).
CONCLUSIONS
Among patients who had a previous ACS and who were receiving high-intensity statin therapy, the risk of recurrent ischemic CVEs was lower among those who received alirocumab than among those who received placebo.