Chief Resident, Internal Medicine, Huntington Memorial Hospital

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.