Cardiovascular outcome trial · N Engl J Med 2018
ODYSSEY OUTCOMES trial
Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome.
The bottom line
In post-ACS patients already on high-intensity statins, adding alirocumab reduced recurrent cardiovascular events and all-cause death compared with placebo.
BenefitUS status: US-approved
At a glance
- Medicine
- Alirocumab 75 mg subcutaneously every 2 weeks (dose adjusted under blinded conditions to target LDL cholesterol 25 to 50 mg/deciliter), 9462 patients
- Compared with
- Matching placebo, 9462 patients
- People
- 18,924
- Who took part
- Patients who had an acute coronary syndrome 1 to 12 months earlier, with LDL cholesterol ≥70 mg/dl (1.8 mmol/liter), non-HDL cholesterol ≥100 mg/dl (2.6 mmol/liter), or apolipoprotein B ≥80 mg/dl, receiving statin therapy at a high-intensity dose or at the maximum tolerated dose
- Design
- multicenter, randomized, double-blind, placebo-controlled trial
- Follow-up
- median duration of follow-up was 2.8 years
- Main question
- Composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization
Main result
A composite primary end-point event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (hazard ratio, 0.85; 95% confidence interval [CI], 0.78 to 0.93; P<0.001)
Effect on LDL cholesterol
The dose of alirocumab was adjusted under blinded conditions to target an LDL cholesterol level of 25 to 50 mg per deciliter (0.6 to 1.3 mmol per liter)
Other results
A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died (hazard ratio, 0.85; 95% CI, 0.73 to 0.98)
Safety
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)
In the trial's own words
“A composite primary end-point event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (hazard ratio, 0.85; 95% confidence interval [CI], 0.78 to 0.93; P<0.001).”
Quoted from the abstract of N Engl J Med 2018, checked word for word against PubMed. PubMed 30403574 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Evolocumab (Repatha) and alirocumab (Praluent)
Common questions
What did the ODYSSEY OUTCOMES trial find?
In post-ACS patients already on high-intensity statins, adding alirocumab reduced recurrent cardiovascular events and all-cause death compared with placebo.
Who was in ODYSSEY OUTCOMES?
18,924 people. Patients who had an acute coronary syndrome 1 to 12 months earlier, with LDL cholesterol ≥70 mg/dl (1.8 mmol/liter), non-HDL cholesterol ≥100 mg/dl (2.6 mmol/liter), or apolipoprotein B ≥80 mg/dl, receiving statin therapy at a high-intensity dose or at the maximum tolerated dose.
What was ODYSSEY OUTCOMES's main result?
A composite primary end-point event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (hazard ratio, 0.85; 95% confidence interval [CI], 0.78 to 0.93; P<0.001)
How much did LDL cholesterol change in ODYSSEY OUTCOMES?
The dose of alirocumab was adjusted under blinded conditions to target an LDL cholesterol level of 25 to 50 mg per deciliter (0.6 to 1.3 mmol per liter)
Related trials
- EBBINGHAUS (2017)Adding evolocumab to statin therapy did not worsen cognitive function compared with placebo over a median follow-up of 19 months.
- FOURIER (2017)Adding evolocumab to statin therapy substantially lowers LDL cholesterol and reduces cardiovascular events in patients with atherosclerotic cardiovascular disease, with injection-site reactions being the main added safety concern.
- ORION-1 (2017)In this phase 2 trial, inclisiran produced substantial, dose-dependent, and durable reductions in LDL cholesterol and PCSK9 levels in high cardiovascular risk patients, with an acceptable safety profile, but the trial was not designed to assess cardiovascular outcomes.
- SPIRE-1/2 (2017)Bococizumab substantially lowered LDL cholesterol but showed no significant reduction in major cardiovascular events overall, with benefit seen only in the higher-risk trial, and the drug's development was discontinued due to high rates of antidrug antibodies and injection-site reactions.
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