Cardiovascular outcome trial · N Engl J Med 2012
dal-OUTCOMES trial
Effects of dalcetrapib in patients with a recent acute coronary syndrome.
The bottom line
In patients with a recent acute coronary syndrome, dalcetrapib raised HDL cholesterol but did not reduce cardiovascular events or mortality compared with placebo.
No significant benefitUS status: Not approved
At a glance
- Medicine
- Dalcetrapib 600 mg daily, in addition to best available evidence-based care
- Compared with
- Placebo, in addition to best available evidence-based care
- People
- 15,871
- Who took part
- Patients who had had a recent acute coronary syndrome
- Design
- randomized
- Follow-up
- median of 31 months
- Main question
- Composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, unstable angina, or cardiac arrest with resuscitation
Main result
Cumulative event rate, 8.0% and 8.3%, respectively; hazard ratio with dalcetrapib, 1.04; 95% confidence interval, 0.93 to 1.16; P=0.52
Effect on LDL cholesterol
Dalcetrapib had a minimal effect on LDL cholesterol levels; HDL cholesterol levels increased from baseline by 4 to 11% in the placebo group and by 31 to 40% in the dalcetrapib group
Other results
Did not have a significant effect on any component of the primary end point or total mortality
Safety
The median C-reactive protein level was 0.2 mg per liter higher and the mean systolic blood pressure was 0.6 mm Hg higher with dalcetrapib as compared with placebo (P<0.001 for both comparisons)
In the trial's own words
“As compared with placebo, dalcetrapib did not alter the risk of the primary end point (cumulative event rate, 8.0% and 8.3%, respectively; hazard ratio with dalcetrapib, 1.04; 95% confidence interval, 0.93 to 1.16; P=0.52) and did not have a significant effect on any component of the primary end point or total mortality.”
Quoted from the abstract of N Engl J Med 2012, checked word for word against PubMed. PubMed 23126252 · Full paper (DOI)
Common questions
What did the dal-OUTCOMES trial find?
In patients with a recent acute coronary syndrome, dalcetrapib raised HDL cholesterol but did not reduce cardiovascular events or mortality compared with placebo.
Who was in dal-OUTCOMES?
15,871 people. Patients who had had a recent acute coronary syndrome.
What was dal-OUTCOMES's main result?
Cumulative event rate, 8.0% and 8.3%, respectively; hazard ratio with dalcetrapib, 1.04; 95% confidence interval, 0.93 to 1.16; P=0.52
How much did LDL cholesterol change in dal-OUTCOMES?
Dalcetrapib had a minimal effect on LDL cholesterol levels; HDL cholesterol levels increased from baseline by 4 to 11% in the placebo group and by 31 to 40% in the dalcetrapib group
Related trials
- ILLUMINATE (2007)Adding torcetrapib to atorvastatin raised HDL and lowered LDL but increased cardiovascular events and overall death, so the trial was stopped early and the drug should not be used.
- ACCELERATE (2017)Despite markedly improving LDL and HDL cholesterol levels, evacetrapib did not reduce cardiovascular events compared with placebo in high-risk vascular disease patients, and the trial was stopped early for futility.
- REVEAL (2017)Adding the CETP inhibitor anacetrapib to intensive statin therapy modestly reduced major coronary events in patients with atherosclerotic vascular disease, without significant safety concerns.
- BROADWAY (2025)In high-risk patients already on maximum tolerated lipid-lowering therapy, adding obicetrapib 10 mg daily lowered LDL cholesterol by about 30% more than placebo with a similar rate of adverse events.
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