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Odkazy a zdroje - Studie - TNT



TNT

Treating to New Targets

Author(s)
LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK; Treating to New Targets (TNT) Investigators

Title(s)
Intensive lipid lowering with atorvastatin in patients with stable coronary disease

Reference(s)
N Engl J Med. 2005 Apr 7;352(14):1425-35

Disease
Stable coronary disease (CHD) and and LDL cholesterol levels less than 3.4 mmol per liter (130 mg per deciliter)

Purpose
To assess whether lowering LDL cholesterol levels below currently recomended target of 2.6 mmol per liter (100 mg per deciliter) can provide additional CHD risk reduction in patients with stable CHD

Study design
Randomized, double-blind, placebo controlled trial conducted in 256 centres in Australia, Europe, Canada, USA and South Africa.
The primary end point was the occurrence of a first major cardiovascular event, defined as death from CHD, nonfatal non-procedure-related myocardial infarction, resuscitation after cardiac arrest, or fatal or nonfatal stroke.

Follow-up
Median 4.9 years

Patients
A total of 10,001 patients aged 35-75 years with clinically evident stable doronary heart disease and LDL cholesterol levels of less than 3.4 mmol per liter (130 mg per deciliter)

Treatment regimen
Patients were randomly assigned to double-blind therapy and received either 10 mg or 80 mg of atorvastatin per day

Concomitant therapy
-

Results
The 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. 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). 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). There was no difference between the two treatment groups in overall mortality.
In summary, intensive lipid-lowering therapy with 80 mg of atorvastatin per day in patients with stable CHD provides significant clinical benefit beyond that afforded by treatment with 10 mg of atorvastatin per day. This occurred with a greater incidence of elevated aminotransferase levels.