Odyssey outcomes

Odyssey Outcomes: Addition of PCSK9i to background Statin therapy further reduces MACE.

Study Design¹

Major Primary endpoints¹

The primary endpoint was a composite of:

• Death from coronary heart disease
• Nonfatal myocardial infarction
• Fatal or nonfatal ischemic stroke
• Unstable angina requiring hospitalization.

Major Secondary efficacy Endpoints²

Tested in the following hierarchical sequence:

• CHD event: CHD death, nonfatal MI, unstable angina requiring hospitalization, or ischaemia-driven coronary revascularization*
• Major CHD event: CHD death or nonfatal MI
• CV event: CV death, nonfatal CHD event, or nonfatal ischaemic stroke
• All-cause death, nonfatal MI, nonfatal ischaemic stroke
• CHD death
• CV death
• All-cause death

*Revascularization performed because of recurrent ACS, new or progressive symptoms of myocardial ischemia or new or progressive abnormalities on functional testing, except revascularization due to restenosis at a prior coronary intervention site.

Odyssey Outcomes: Addition of PCSK9i to background Statin therapy further reduces MACE

Safety: Incidence or adverse events and laboratory abnormalities was similar in the alirocumab group and the placebo group, apart from local injection-site reaction (3.8% in alirocumab group vs 2.1% in the placebo group, p<0.001).

ᵃ Primary efficacy endpoint (a composite of death from CHD, nonfatal MI, fatal or nonfatal ischaemic stroke, or unstable angina requiring hospitalization)

Primary MACE, All-cause death and safety

Safety

Similar incidence of adverse events and laboratory abnormalities in the alirocumab group and the placebo group, except for local injection-site reactions (3 .8% in the alirocumab group vs 2.1% in the placebo group, p<0.001)¹

*Nominal p-value; ᵃBased on cumulative incidence; bp-interaction value for ARR <0.001 in post-hoc analysis

All-cause death⁴

*Nominal p-value

†Based on cumulative incidence

Primary Analysis Conclusions¹

• The primary results show that, compared with placebo in patients with recent ACS, alirocumab 75 or 150 mg SC twice a week targeting LDL-C levels 25-50 mg/dl reduced MACE, MI*, ischemic stroke* and was associated with a lower rate of all-cause death
• Among patients with ACS and baseline LDL-C >100 mg/dl, alirocumab was well tolerated, reduced MACE by 24% (absolute risk reduction [ARR] 3.4%), and was associated with a lower rate of all-cause death compared with placebo

*Nominally significant as per hierarchical testing.

View published article

 

MAT-BH-2100561/v2/Jun 2023