Lipid-efficacy RCT · N Engl J Med 2014
DESCARTES trial
A 52-week placebo-controlled trial of evolocumab in hyperlipidemia.
The bottom line
In patients with hyperlipidemia across a range of background lipid therapies, adding evolocumab for 52 weeks substantially lowered LDL cholesterol compared with placebo.
Primary lipid endpoint metUS status: US-approved
At a glance
- Medicine
- Evolocumab 420 mg every 4 weeks, added to background therapy (diet alone, atorvastatin 10 mg, atorvastatin 80 mg, or atorvastatin 80 mg plus ezetimibe 10 mg)
- Compared with
- Placebo (added to same background lipid-lowering therapy)
- People
- 901
- Who took part
- Patients with hyperlipidemia stratified by Adult Treatment Panel III risk categories, with LDL cholesterol ≥75 mg/dL (1.9 mmol/L) after a 4- to 12-week run-in on background lipid-lowering therapy
- Design
- Randomized, placebo-controlled, phase 3 trial (2:1 randomization) with background lipid-lowering therapy stratified by risk category
- Follow-up
- 52 weeks
- Main question
- Percent change from baseline in LDL cholesterol (measured by ultracentrifugation) at week 52
Main result
Overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P<0.001)
Effect on LDL cholesterol
Overall LDL-C reduction vs placebo of 57.0±2.1% (P<0.001); by background therapy: 55.7±4.2% (diet alone), 61.6±2.6% (atorvastatin 10 mg), 56.8±5.3% (atorvastatin 80 mg), 48.5±5.2% (atorvastatin 80 mg + ezetimibe 10 mg) (P<0.001 for all comparisons)
Other results
Evolocumab treatment also significantly reduced levels of apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and triglycerides.
Safety
The most common adverse events were nasopharyngitis, upper respiratory tract infection, influenza, and back pain.
In the trial's own words
“Among the 901 patients included in the primary analysis, the overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P<0.001).”
Quoted from the abstract of N Engl J Med 2014, checked word for word against PubMed. PubMed 24678979 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Evolocumab (Repatha) and alirocumab (Praluent)
Common questions
What did the DESCARTES trial find?
In patients with hyperlipidemia across a range of background lipid therapies, adding evolocumab for 52 weeks substantially lowered LDL cholesterol compared with placebo.
Who was in DESCARTES?
901 people. Patients with hyperlipidemia stratified by Adult Treatment Panel III risk categories, with LDL cholesterol ≥75 mg/dL (1.9 mmol/L) after a 4- to 12-week run-in on background lipid-lowering therapy.
What was DESCARTES's main result?
Overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P<0.001)
How much did LDL cholesterol change in DESCARTES?
Overall LDL-C reduction vs placebo of 57.0±2.1% (P<0.001); by background therapy: 55.7±4.2% (diet alone), 61.6±2.6% (atorvastatin 10 mg), 56.8±5.3% (atorvastatin 80 mg), 48.5±5.2% (atorvastatin 80 mg + ezetimibe 10 mg) (P<0.001 for all comparisons)
Related trials
- MENDEL-2 (2014)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.
- 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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