Lipid-efficacy RCT · N Engl J Med 2015
ODYSSEY LONG TERM trial
Efficacy and safety of alirocumab in reducing lipids and cardiovascular events.
The bottom line
Adding alirocumab to maximally tolerated statin therapy markedly lowered LDL cholesterol and was associated with a post hoc reduction in cardiovascular events, though with somewhat higher rates of injection-site reactions, myalgia, neurocognitive, and ophthalmologic events.
Primary lipid endpoint metUS status: US-approved
At a glance
- Medicine
- Alirocumab 150 mg as a 1-ml subcutaneous injection every 2 weeks
- Compared with
- Placebo
- People
- 2,341
- Who took part
- Patients at high risk for cardiovascular events with LDL cholesterol levels of 70 mg/dL (1.8 mmol/L) or more, receiving statins at the maximum tolerated dose, with or without other lipid-lowering therapy
- Design
- randomized, 2:1 allocation, placebo-controlled (double-blind not specified)
- Follow-up
- 78 weeks
- Main question
- Percentage change in calculated LDL cholesterol level from baseline to week 24
Main result
At week 24, the difference between the alirocumab and placebo groups in the mean percentage change from baseline in calculated LDL cholesterol level was -62 percentage points (P<0.001); the treatment effect remained consistent over a period of 78 weeks.
Effect on LDL cholesterol
-62 percentage points difference vs placebo at week 24 (P<0.001), consistent over 78 weeks
Other results
In a post hoc analysis, the rate of major adverse cardiovascular events (death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization) was lower with alirocumab than with placebo (1.7% vs. 3.3%; hazard ratio, 0.52; 95% confidence interval, 0.31 to 0.90; nominal P=0.02).
Safety
The alirocumab group, as compared with the placebo group, had higher rates of injection-site reactions (5.9% vs. 4.2%), myalgia (5.4% vs. 2.9%), neurocognitive events (1.2% vs. 0.5%), and ophthalmologic events (2.9% vs. 1.9%).
In the trial's own words
“At week 24, the difference between the alirocumab and placebo groups in the mean percentage change from baseline in calculated LDL cholesterol level was -62 percentage points (P<0.001); the treatment effect remained consistent over a period of 78 weeks.”
Quoted from the abstract of N Engl J Med 2015, checked word for word against PubMed. PubMed 25773378 · 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 LONG TERM trial find?
Adding alirocumab to maximally tolerated statin therapy markedly lowered LDL cholesterol and was associated with a post hoc reduction in cardiovascular events, though with somewhat higher rates of injection-site reactions, myalgia, neurocognitive, and ophthalmologic events.
Who was in ODYSSEY LONG TERM?
2,341 people. Patients at high risk for cardiovascular events with LDL cholesterol levels of 70 mg/dL (1.8 mmol/L) or more, receiving statins at the maximum tolerated dose, with or without other lipid-lowering therapy.
What was ODYSSEY LONG TERM's main result?
At week 24, the difference between the alirocumab and placebo groups in the mean percentage change from baseline in calculated LDL cholesterol level was -62 percentage points (P<0.001); the treatment effect remained consistent over a period of 78 weeks.
How much did LDL cholesterol change in ODYSSEY LONG TERM?
-62 percentage points difference vs placebo at week 24 (P<0.001), consistent over 78 weeks
Related trials
- ODYSSEY ALTERNATIVE (2015)In statin-intolerant patients, alirocumab lowered LDL-C far more than ezetimibe and caused fewer muscle-related adverse events than statin rechallenge with atorvastatin.
- ODYSSEY FH I and II (2015)In patients with heterozygous familial hypercholesterolemia inadequately controlled on maximally tolerated lipid-lowering therapy, adding alirocumab produced large, durable LDL-C reductions through 78 weeks and was generally well tolerated.
- RUTHERFORD-2 (2015)In patients with heterozygous familial hypercholesterolaemia on stable lipid-lowering therapy, adding evolocumab produced rapid, large LDL cholesterol reductions of about 60% compared with placebo with a tolerability profile similar to placebo.
- TESLA Part B (2015)In patients with homozygous familial hypercholesterolaemia on stable background therapy, adding evolocumab 420 mg every 4 weeks significantly lowered LDL cholesterol compared with placebo and was well tolerated over 12 weeks.
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