Cardiovascular outcome trial · N Engl J Med 2007
ILLUMINATE trial
Effects of torcetrapib in patients at high risk for coronary events.
The bottom line
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.
HarmUS status: Discontinued
At a glance
- Medicine
- Torcetrapib plus atorvastatin
- Compared with
- Atorvastatin alone
- People
- 15,067
- Who took part
- Patients at high risk for coronary events
- Design
- Randomized, double-blind study (terminated prematurely)
- Follow-up
- 12 months (lipid/safety measures reported at 12 months; trial terminated prematurely)
- Main question
- Time to first major cardiovascular event, defined as death from coronary heart disease, nonfatal myocardial infarction, stroke, or hospitalization for unstable angina
Main result
Increased risk of cardiovascular events (hazard ratio, 1.25; 95% confidence interval [CI], 1.09 to 1.44; P=0.001)
Effect on LDL cholesterol
Decrease of 24.9% in LDL cholesterol compared with baseline (P<0.001)
Other results
Death from any cause: hazard ratio, 1.58; 95% CI, 1.14 to 2.19; P=0.006
Safety
5.4 mm Hg increase in systolic blood pressure, decrease in serum potassium, increases in serum sodium, bicarbonate, and aldosterone (P<0.001 for all comparisons); post hoc analyses showed increased risk of death in patients whose reduction in potassium or increase in bicarbonate was greater than the median change.
In the trial's own words
“There was also an increased risk of cardiovascular events (hazard ratio, 1.25; 95% confidence interval [CI], 1.09 to 1.44; P=0.001) and death from any cause (hazard ratio, 1.58; 95% CI, 1.14 to 2.19; P=0.006).”
Quoted from the abstract of N Engl J Med 2007, checked word for word against PubMed. PubMed 17984165 · Full paper (DOI)
Common questions
What did the ILLUMINATE trial find?
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.
Who was in ILLUMINATE?
15,067 people. Patients at high risk for coronary events.
What was ILLUMINATE's main result?
Increased risk of cardiovascular events (hazard ratio, 1.25; 95% confidence interval [CI], 1.09 to 1.44; P=0.001)
How much did LDL cholesterol change in ILLUMINATE?
Decrease of 24.9% in LDL cholesterol compared with baseline (P<0.001)
Related trials
- dal-OUTCOMES (2012)In patients with a recent acute coronary syndrome, dalcetrapib raised HDL cholesterol but did not reduce cardiovascular events or mortality compared with placebo.
- 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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