Lipid-efficacy RCT · J Am Coll Cardiol 2014
MENDEL-2 trial
Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab.
The bottom line
In people with moderate hypercholesterolemia and low cardiovascular risk, evolocumab monotherapy (biweekly or monthly) lowered LDL-C far more than placebo or ezetimibe and had a similar rate of side effects as placebo/ezetimibe.
Primary lipid endpoint metUS status: US-approved
At a glance
- Medicine
- Evolocumab 140 mg SC biweekly or 420 mg SC monthly (with oral placebo)
- Compared with
- Oral placebo and SC placebo (biweekly/monthly); ezetimibe and SC placebo (biweekly/monthly)
- People
- 614
- Who took part
- Patients 18 to 80 years of age with fasting LDL-C ≥100 and <190 mg/dl and Framingham risk scores ≤10% with hypercholesterolemia
- Design
- Randomized, controlled phase III trial (1:1:1:1:2:2 allocation)
- Follow-up
- ''
- Main question
- LDL-C reduction from baseline compared with placebo and ezetimibe
Main result
Evolocumab treatment reduced LDL-C from baseline, on average, by 55% to 57% more than placebo and 38% to 40% more than ezetimibe (p < 0.001 for all comparisons).
Effect on LDL cholesterol
Evolocumab treatment reduced LDL-C from baseline, on average, by 55% to 57% more than placebo and 38% to 40% more than ezetimibe (p < 0.001 for all comparisons).
Other results
Evolocumab treatment also favorably altered other lipoprotein levels.
Safety
Treatment-emergent adverse events (AEs), muscle-related AEs, and laboratory abnormalities were comparable across treatment groups.
In the trial's own words
“Evolocumab treatment reduced LDL-C from baseline, on average, by 55% to 57% more than placebo and 38% to 40% more than ezetimibe (p < 0.001 for all comparisons).”
Quoted from the abstract of J Am Coll Cardiol 2014, checked word for word against PubMed. PubMed 24691094 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Evolocumab (Repatha) and alirocumab (Praluent)
Common questions
What did the MENDEL-2 trial find?
In people with moderate hypercholesterolemia and low cardiovascular risk, evolocumab monotherapy (biweekly or monthly) lowered LDL-C far more than placebo or ezetimibe and had a similar rate of side effects as placebo/ezetimibe.
Who was in MENDEL-2?
614 people. Patients 18 to 80 years of age with fasting LDL-C ≥100 and <190 mg/dl and Framingham risk scores ≤10% with hypercholesterolemia.
What was MENDEL-2's main result?
Evolocumab treatment reduced LDL-C from baseline, on average, by 55% to 57% more than placebo and 38% to 40% more than ezetimibe (p < 0.001 for all comparisons).
How much did LDL cholesterol change in MENDEL-2?
Evolocumab treatment reduced LDL-C from baseline, on average, by 55% to 57% more than placebo and 38% to 40% more than ezetimibe (p < 0.001 for all comparisons).
Related trials
- DESCARTES (2014)In patients with hyperlipidemia across a range of background lipid therapies, adding evolocumab for 52 weeks substantially lowered LDL cholesterol compared with placebo.
- 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.
- 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.
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