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Odkazy a zdroje - Studie - ALLIANCE



ALLIANCE

Aggressive Lipid-Lowering Initiation Abates New Cardiac Events

Author(s)
Koren MJ, Hunninghake DB.

Title(s)
Using a trial design adapted to approximate clinical settings, the Aggressive Lipid- Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial compared a focused treatment strategy using atorvastatin with usual medical care.

Reference(s)
Koren MJ, Hunninghake DB.J Am Coll Cardiol. 2004;44:1772-1779.

Disease
Coronary artery disease, dyslipidemia

Purpose
To asses differences between aggressive targeted lipid lowering with statins and usual care in patients with coronary artery disease in a real world setting

Study design
2442 CAD patients were randomized to either atorvastatin titrated to achieve LDL-c target value (LDL-c<2.1mmol/l) or to a maximum dose of 80mg daily or to usual care. 66% of patients were taking lipid lowering medications at study entry.

Follow-up
51.5 months

Patients
A total of 2,442 patients were recruited from among approximately 100,000 patients identified through managed care databases in 16 communities throughout the United States. Of these, 1,217 patients were assigned to the atorvastatin arm and 1,225 to the usual-care group. The study enrolled both men and women (aged 18 to 78 years) with a history of CHD. For trial purposes, CHD was defined as acute myocardial infarction (MI) _3 months before screening, percutaneous transluminal coronary angioplasty 6 months before screening, or coronary artery bypass grafting or unstable angina 3 months before screening. The mean age for both treatment groups was 61 years, and 82% of randomized patients were men. Risk factors were comparable across the 2 treatment groups and patients were followed, on average, for 51.5 months. The mean LDL cholesterol levels at baseline were similar:147 mg/dL (3.8 mmol/L) in atorvastatin-treated patiens and 146 mg/dL (3.8 mmol/L) in the usual-care group.

Treatment regimen
Usual-care patients were treated completely at the discretion of their physician. Patients in the focused treatment arm were treated with atorvastatin 10 mg/day with the option of doubling the dose every 4 weeks until an LDL cholesterol level of _80 mg/dL (_2.1 mmol/L) or a maximum dose of 80 mg/day was achieved. The median dose of atorvastatin received by patients in this arm was 40.5 mg/day and slightly _50% of patients were taking 80 mg/day.

Concomitant therapy
-

Results
The primary end point for ALLIANCE was the time from randomization to the first occurrence of a primary cardiovascular event. Primary events included cardiac death, nonfatal MI, resuscitated cardiac arrest, cardiac revascularization, and unstable angina requiring hospitalization. Based on a Cox regression model, patients treated with a focused regimen of atorvastatin attained a 17% reduction in the risk of a primary cardiovascular outcome when compared with usual care (hazard ratio [HR] _ 0.829; P _ 0.02). This benefit of targeted atorvastatin treatment was due in large part to a significant reduction in incidence of nonfatal MI in this cohort. For nonfatal MI, the Cox regression analysis estimated a 47% reduction in risk for patients in the atorvastatin group (HR _ 0.526; P _ 0.0002) versus usual care. Atorvastatin-treated patients experienced numerically fewer primary events for each of the remaining components of the composite end point (cardiac death, resuscitated cardiac arrest, cardiac revascularization, and unstable angina requiring hospitalization). These differences were not statistically significant, although the outcome for cardiac death averaged on significance (P _ 0.057 for focused atorvastatin therapy over usual care). Given this trend toward significance, a post hoc analysis was performed on the combined end points of nonfatal MI and cardiac death. Patients in the targeted atorvastatin group experienced a 43% reduction in these 2 “hard” end points compared with the usual-care group (HR _ 0.574; P _ 0.0001).