Pharmacy Times

Aggressive lipid lowering superior to usual care in a real-world setting: The ALLIANCE study


NEW ORLEANS?In a real-world setting of managed care or Veterans Administration hospitals, more patients with coronary heart disease randomized to an aggressive lipid-lowering regimen achieved their low-density lipoprotein (LDL) cholesterol target levels compared with patients receiving usual care. The aggressive treatment group also had fewer cardiac events. The Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) study enrolled 2442 patients for 4 years. The aggressive treatment group received 10 to 80 mg of atorvastatin daily, titrated to achieve an LDL cholesterol level of <80 mg/dL, or up to the maximum dose. No concomitant lipid-lowering drugs were allowed.

The usual care group was treated with cholesterol-lowering therapies (eg, drugs, weight loss, exercise, and diet modification) according to standard clinical practice. They were allowed atorvastatin after its approval in 1997.

The primary end point of the trial was the time to the composite end point of cardiac death, nonfatal myocardial infarction (MI), resuscitated cardiac arrest, cardiac revascularization, or unstable angina requiring hospitalization. Principal investigator Donald B. Hunninghake, MD, professor of medicine and pharmacology at the University of Minnesota, said atorvastatin allowed 72% of patients to reach their recommended LDL cholesterol goals of <100 mg/dL compared with only 40% of patients on usual care. From an initial baseline LDL cholesterol level of 147 mg/dL, the atorvastatin group achieved a final level of 95 mg/dL versus 111 mg/dL for the usual care group (P < .0001).

Patients taking atorvastatin experienced 47% fewer nonfatal MIs (P = .0002) and a 17% reduction in overall negative cardiovascular outcomes, including cardiac death, MIs, strokes, and hospitalizations, compared with patients randomized to usual care over the course of the trial (P = .02).

Dr Hunninghake said that this trial shows that LDL cholesterol reductions can also be achieved outside of a clinical trial. He emphasized that the 16-mg/dL difference in LDL cholesterol levels between the 2 groups "resulted in very significant benefit." He predicted that this strategy could substantially lower the total burden of coronary disease in this country.

Lower costs when LDL goals attained?Swedish study

In another study presented at the meeting, Jan St?llhammar, MD, and colleagues from the Karolinska Institute in Stockholm, Sweden, showed that 70% of the 9789 patients receiving lipid-lowering therapy in 29 primary care centers in Sweden between 1993 and 2003 did not achieve their LDL cholesterol target based on a review of their medical records. The population included both primary and secondary prevention patients.

Coauthor Linus J?nsson, an internist at the St. G?ran Hospital and a researcher at Stockholm Health Economics, said, "There is a trend here to a lower cost of care especially for inpatient care related to cardiovascular disease for those patients who had attained the treatment goal."

Dr J?nsson said charts indicated many patients did not have a cholesterol measurement after the initiation of treatment, so they could not even be included in the study.

A similar lack of monitoring and treatment adjustments may play a role for those patients in the study who did not reach their LDL cholesterol goal.