Lipid-efficacy RCT · Eur Heart J 2015
ODYSSEY FH I and II trial
ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia.
The bottom line
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.
Primary lipid endpoint metUS status: US-approved
At a glance
- Medicine
- Alirocumab 75 mg Q2W (up-titrated to 150 mg Q2W at Week 12 if Week 8 LDL-C ≥1.8 mmol/L [70 mg/dL])
- Compared with
- Placebo (added to maximally tolerated lipid-lowering therapy), every 2 weeks
- People
- 735
- Who took part
- Patients with heterozygous familial hypercholesterolaemia (HeFH) and inadequate LDL-C control on maximally tolerated lipid-lowering therapy (LLT)
- Design
- Two randomized, double-blind, placebo-controlled studies; 2:1 randomization to alirocumab or placebo
- Follow-up
- 78 weeks
- Main question
- Percentage change in calculated LDL-C from baseline to Week 24
Main result
-57.9% vs. placebo (FH I) and -51.4% vs. placebo (FH II) at Week 24 (P < 0.0001)
Effect on LDL cholesterol
-57.9% vs. placebo (FH I) and -51.4% vs. placebo (FH II) at Week 24, maintained through Week 78
Other results
LDL-C <1.8 mmol/L (regardless of cardiovascular risk) was achieved at Week 24 by 59.8 and 68.2% of alirocumab-treated patients in FH I and FH II, respectively.
Safety
Adverse events resulted in discontinuation in 3.4% of alirocumab-treated patients in FH I (vs. 6.1% placebo) and 3.6% (vs. 1.2%) in FH II. Rate of injection site reactions in alirocumab-treated patients was 12.4% in FH I and 11.4% in FH II (vs. 11.0 and 7.4% with placebo).
In the trial's own words
“Mean LDL-C levels decreased from 3.7 mmol/L (144.7 mg/dL) at baseline to 1.8 mmol/L (71.3 mg/dL; -57.9% vs. placebo) at Week 24 in patients randomized to alirocumab in FH I and from 3.5 mmol/L (134.6 mg/dL) to 1.8 mmol/L (67.7 mg/dL; -51.4% vs. placebo) in FH II (P < 0.0001). These reductions were maintained through Week 78.”
Quoted from the abstract of Eur Heart J 2015, checked word for word against PubMed. PubMed 26330422 · 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 FH I and II trial find?
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.
Who was in ODYSSEY FH I and II?
735 people. Patients with heterozygous familial hypercholesterolaemia (HeFH) and inadequate LDL-C control on maximally tolerated lipid-lowering therapy (LLT).
What was ODYSSEY FH I and II's main result?
-57.9% vs. placebo (FH I) and -51.4% vs. placebo (FH II) at Week 24 (P < 0.0001)
How much did LDL cholesterol change in ODYSSEY FH I and II?
-57.9% vs. placebo (FH I) and -51.4% vs. placebo (FH II) at Week 24, maintained through Week 78
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 LONG TERM (2015)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.
- 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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