Cardiovascular outcome trial · N Engl J Med 2005
TNT trial
Intensive lipid lowering with atorvastatin in patients with stable coronary disease.
The bottom line
In patients with stable coronary disease, treating to a much lower LDL target with high-dose atorvastatin (80 mg) further reduced major cardiovascular events compared with the standard 10 mg dose, though with more liver enzyme elevations and no difference in overall mortality.
BenefitUS status: US-approved
At a glance
- Medicine
- Atorvastatin 80 mg per day
- Compared with
- Atorvastatin 10 mg per day
- People
- 10,001
- Who took part
- Patients with clinically evident coronary heart disease (CHD) and LDL cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter)
- Design
- Randomized, double-blind
- Follow-up
- median of 4.9 years
- Main question
- First major cardiovascular event, defined as death from CHD, nonfatal non-procedure-related myocardial infarction, resuscitation after cardiac arrest, or fatal or nonfatal stroke
Main result
A primary event occurred in 434 patients (8.7 percent) receiving 80 mg of atorvastatin, as compared with 548 patients (10.9 percent) receiving 10 mg of atorvastatin, representing an absolute reduction in the rate of major cardiovascular events of 2.2 percent and a 22 percent relative reduction in risk (hazard ratio, 0.78; 95 percent confidence interval, 0.69 to 0.89; P<0.001).
Effect on LDL cholesterol
Mean LDL cholesterol levels were 77 mg per deciliter (2.0 mmol per liter) during treatment with 80 mg of atorvastatin and 101 mg per deciliter (2.6 mmol per liter) during treatment with 10 mg of atorvastatin.
Other results
There was no difference between the two treatment groups in overall mortality.
Safety
The incidence of persistent elevations in liver aminotransferase levels was 0.2 percent in the group given 10 mg of atorvastatin and 1.2 percent in the group given 80 mg of atorvastatin (P<0.001).
In the trial's own words
“A primary event occurred in 434 patients (8.7 percent) receiving 80 mg of atorvastatin, as compared with 548 patients (10.9 percent) receiving 10 mg of atorvastatin, representing an absolute reduction in the rate of major cardiovascular events of 2.2 percent and a 22 percent relative reduction in risk (hazard ratio, 0.78; 95 percent confidence interval, 0.69 to 0.89; P<0.001).”
Quoted from the abstract of N Engl J Med 2005, checked word for word against PubMed. PubMed 15755765 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the TNT trial find?
In patients with stable coronary disease, treating to a much lower LDL target with high-dose atorvastatin (80 mg) further reduced major cardiovascular events compared with the standard 10 mg dose, though with more liver enzyme elevations and no difference in overall mortality.
Who was in TNT?
10,001 people. Patients with clinically evident coronary heart disease (CHD) and LDL cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter).
What was TNT's main result?
A primary event occurred in 434 patients (8.7 percent) receiving 80 mg of atorvastatin, as compared with 548 patients (10.9 percent) receiving 10 mg of atorvastatin, representing an absolute reduction in the rate of major cardiovascular events of 2.2 percent and a 22 percent relative reduction in risk (hazard ratio, 0.78; 95 percent confidence interval, 0.69 to 0.89; P<0.001).
How much did LDL cholesterol change in TNT?
Mean LDL cholesterol levels were 77 mg per deciliter (2.0 mmol per liter) during treatment with 80 mg of atorvastatin and 101 mg per deciliter (2.6 mmol per liter) during treatment with 10 mg of atorvastatin.
Related trials
- IDEAL (2005)High-dose atorvastatin lowered LDL-C more than usual-dose simvastatin and reduced some secondary cardiovascular endpoints and nonfatal MI, but did not significantly reduce the primary composite of major coronary events or all-cause mortality after prior MI.
- CARDS (2004)In people with type 2 diabetes but no prior cardiovascular disease and no high LDL-cholesterol, taking atorvastatin 10 mg daily substantially lowered the risk of heart attacks, revascularization, and stroke, with no increase in adverse events.
- PROVE IT-TIMI 22 (2004)In patients recently hospitalized for acute coronary syndrome, intensive lipid lowering with high-dose atorvastatin (80 mg) reduced death and major cardiovascular events more than standard-dose pravastatin (40 mg).
- SPARCL (2006)In patients with a recent stroke or TIA but no known coronary disease, high-dose atorvastatin modestly reduced recurrent stroke and cardiovascular events, though it slightly increased hemorrhagic stroke risk and did not improve overall mortality.
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