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Aggressive Lipid-Lowering Initiation Abates New Cardiac Events - ALLIANCE
Description:
The goal of the trial was to evaluate the effect of an aggressive lipid-lowering program using atorvastatin compared with usual care on cardiovascular events in patients with a history of coronary artery disease (CAD) and elevated low-density lipoprotein (LDL) levels in a managed care population.
Hypothesis:
Treatment with an aggressive lipid-lowering program using atorvastatin will be associated with fewer cardiovascular events compared with usual care in patients with a history of CAD and elevated LDL levels.
Study Design
Study Design:
Patients Screened: 3,451
Patients Enrolled: 2,442
Mean Follow Up: Mean follow-up 52 months
Mean Patient Age: Mean age 61 years
Female: 18
Patient Populations:
Age ≥18 years, history of CAD (acute MI >3 months prior, percutaneous transluminal coronary angioplasty >6 months prior, or coronary artery bypass grafting or unstable angina >3 months prior), and LDL 130-250 mg/dl if not on hyperlipidemic medication or LDL 110-200 mg/dl if on hyperlipidemic medication
Primary Endpoints:
Time to first cardiovascular event including cardiovascular death, nonfatal MI, cardiac revascularization, resuscitated cardiac arrest, or hospitalization for an acute coronary syndrome
Drug/Procedures Used:
Patients were randomized to either atorvastatin (10-80 mg/day) titrated as needed to reach an LDL cholesterol level of <80 mg/dl or to a maximum dose of 80 mg (n=1,217) or usual care (n=1,225). Usual care patients received treatment as directed by their physicians, including diet, behavior modification, or lipid-lowering medication, and treatment could be changed during the study duration per current recommendations.
Principal Findings:
The study began in 1995 and ended in 2002. The mean dose in the atorvastatin arm was 40.5 mg/day. Two-thirds of patients were on lipid-lowering medication prior to enrollment in the study.
There was no difference in baseline LDL levels (147 mg/dl each), but the reduction in the final LDL level was greater in the atorvastatin arm compared with usual care (95 mg/dl vs. 110 mg/dl, p<0.001). Target level of LDL cholesterol, as defined by the Adult Treatment Panel III (<100 mg/dl), was reached in 72.4% of patients in the atorvastatin arm and 40.0% of patients in the usual care group (p<0.001). Relative change in total cholesterol was also greater in the atorvastatin arm (-24.1% vs. -15.5%, p<0.001), as were triglycerides (-7.4% vs. -2.4%, p<0.05), but there was no difference in change in high-density lipoprotein (HDL) levels.
The primary composite endpoint of cardiovascular events was lower in the atorvastatin arm (23.7% vs. 27.7%, relative reduction [RR] 17%, p=0.02), as was myocardial infarction (MI) (4.3% vs. 7.7%, RR 47%, p=0.0002) and cardiovascular death (n=43 vs. n=61, p=0.057).
There was no difference in the frequency of serious adverse events (40% in the atorvastatin arm vs. 42% of patients in the usual care arm, p=NS). There were no cases of rhabdomyolysis in either group.
Interpretation:
Among patients with a history of CAD and elevated LDL levels in a managed care population, treatment with an aggressive lipid-lowering program with atorvastatin was associated with a reduction in the primary endpoint of cardiovascular events. The trial was designed to evaluate aggressive lipid-lowering with a flexible dosing regimen rather than a lower, fixed dose. At the time of the study initiation, there was limited information and some concern about the safety of high-dose statins.
References:
Koren MJ, et al. Clinical Outcomes in Managed-Care Patients With Coronary Heart Disease Treated Aggressively in Lipid-Lowering Disease Management Clinics. J Am Coll Cardiol 2004;44:1772-9.
Presented by Dr. Michael Koren at the American College of Cardiology Annual Scientific Session, March 2004.
Keywords: Managed Care Programs, Coronary Artery Disease, Myocardial Infarction, Behavior Therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Heptanoic Acids, Hypercholesterolemia, Angioplasty, Balloon, Coronary, Rhabdomyolysis, Pyrroles, Cholesterol, Diet, Triglycerides, Coronary Artery Bypass
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