TNT
Trial question
Is 80 mg atorvastatin superior to 10 mg atorvastatin in patients with stable coronary disease and LDL cholesterol levels of < 130 mg/dL?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 10001
10001 patients (1902 female, 8099 male).
Inclusion criteria: patients with stable coronary disease and LDL cholesterol levels of < 130 mg/dL.
Key exclusion criteria: hypersensitivity to statins; active liver disease or hepatic dysfunction; pregnancy or lactation; nephrotic syndrome; uncontrolled diabetes mellitus; uncontrolled hypothyroidism; or uncontrolled hypertension.
Interventions
N=4995 high-dose atorvastatin (80 mg of atorvastatin).
N=5006 low-dose atorvastatin (10 mg of atorvastatin).
Primary outcome
Major CV events
8.7%
10.9%
10.9 %
8.2 %
5.5 %
2.7 %
0.0 %
High-dose
atorvastatin
Low-dose
atorvastatin
Significant
decrease ▼
NNT = 45
Significant decrease in major CV events (8.7% vs. 10.9%; HR 0.78, 95% CI 0.69 to 0.89).
Secondary outcomes
Significant decrease in major coronary events (6.7% vs. 8.3%; HR 0.8, 95% CI 0.69 to 0.92).
No significant difference in death from any cause (5.7% vs. 5.6%; HR 1.01, 95% CI 0.85 to 1.19).
Significant decrease in cerebrovascular event (3.9% vs. 5%; HR 0.77, 95% CI 0.64 to 0.93).
Safety outcomes
Significant differences in adverse events (8.1% vs. 5.8%, p < 0.001), including persistent elevations in liver aminotransferase levels (1.2% vs. 0.2%, p < 0.001).
Conclusion
In patients with stable coronary disease and LDL cholesterol levels of < 130 mg/dL, high-dose atorvastatin was superior to low-dose atorvastatin with respect to major CV events.
Reference
LaRosa JC, Grundy SM, Waters DD et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005 Apr 7;352(14):1425-35.
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