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Intensive lipid lowering with atorvastatin in patients with stable coronary disease
John C LaRosa1, Scott M Grundy, David D Waters
1State University of New York Health Science Center, Brooklyn, NY 11203, USA.
Insights
Intensive therapy with 80 mg of atorvastatin significantly reduced cardiovascular events in stable coronary heart disease patients. This approach, lowering low-density lipoprotein (LDL) cholesterol, showed greater benefit than standard 10 mg dosing.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Previous studies indicated benefits of lowering low-density lipoprotein (LDL) cholesterol below recommended levels in acute coronary syndromes.
- This study prospectively evaluated intensive LDL cholesterol reduction in stable coronary heart disease (CHD).
Purpose of the Study:
- To assess the efficacy and safety of lowering LDL cholesterol levels below 100 mg/dL in patients with stable CHD.
- To compare the clinical outcomes of high-dose (80 mg) versus standard-dose (10 mg) atorvastatin therapy.
Main Methods:
- 10,001 patients with CHD and LDL < 130 mg/dL were randomized to 10 mg or 80 mg of atorvastatin daily.
- Double-blind therapy was administered for a median follow-up of 4.9 years.
- The primary endpoint was the first major cardiovascular event (CHD death, myocardial infarction, cardiac arrest resuscitation, stroke).
Main Results:
- Mean LDL cholesterol was 77 mg/dL with 80 mg atorvastatin vs. 101 mg/dL with 10 mg atorvastatin.
- Major cardiovascular events occurred in 8.7% of patients on 80 mg vs. 10.9% on 10 mg (22% relative risk reduction).
- Elevated liver aminotransferase levels were more frequent with 80 mg (1.2%) vs. 10 mg (0.2%) atorvastatin.
Conclusions:
- High-dose (80 mg) atorvastatin provides significant clinical benefits in stable CHD patients compared to standard-dose (10 mg).
- Intensive lipid-lowering therapy with 80 mg atorvastatin led to a greater incidence of elevated aminotransferase levels.
- No difference in overall mortality was observed between the treatment groups.
Background:
Previous trials have demonstrated that lowering low-density lipoprotein (LDL) cholesterol levels below currently recommended levels is beneficial in patients with acute coronary syndromes. We prospectively assessed the efficacy and safety of lowering LDL cholesterol levels below 100 mg per deciliter (2.6 mmol per liter) in patients with stable coronary heart disease (CHD).
Methods:
A total of 10,001 patients with clinically evident CHD and LDL cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) were randomly assigned to double-blind therapy and received either 10 mg or 80 mg of atorvastatin per day. Patients were followed for a median of 4.9 years. 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.
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.
Conclusions:
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.
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