http://www.***.com/

appear effective in this group.

Bill

___________________

ALLIANCE: Benefit of aggressive lipid lowering vs usual care in a managed-care
patient population

      Nov 3, 2004  Michael O'Riordan

Jacksonville, FL - Aggressive lipid-lowering therapy with atorvastatin
(Lipitor?, Pfizer) outperformed usual care in a managed-care population of
patients with coronary heart disease.[1] Patients treated with atorvastatin
titrated to LDL cholesterol levels <80 mg/dL or a daily maximum dose of 80 mg
had a 17% reduction in the primary end pointa composite of cardiac death,
nonfatal MI, resuscitated cardiac arrest, cardiac revascularization, and
unstable angina requiring hospitalizationcompared with those treated to usual
care.

"When we designed the study, we wanted to see if we could get the same results
with statin therapy that were seen in clinical trials," Dr Michael Koren
(Jacksonville Center for Clinical Research, FL) told heartwire. "It was
designed to compare different lipid-lowering strategies, but it was also meant
to be a reflection of what was happening in a real-world setting, in this
case, HMOs and Veteran Affairs' hospitals. As it turned out, the aggressive,
focused therapy did produce an improvement in clinical outcomes over usual
care."

The studyknown as the Aggressive Lipid Lowering to Alleviate New
Cardiovascular Endpoints (ALLIANCE) trialwas first presented at the American
College of Cardiology 2004 Scientific Sessions in New Orleans, LA and reported
by heartwire at that time. It is now published in the November 2, 2004 issue
of the Journal of the American Medical Association.

Managed-care population
Patients were recruited into the study by a letter inviting them to be
screened at one of 16 research centers throughout the US. The study was open
only to CHD patients from managed healthcare organizations or Veterans
Administration facility databases. After screening, 2442 eligible CHD patients
were randomized to an aggressive lipid-lowering regimen or to usual care,
defined as lipid treatment that included cholesterol-lowering medications,
including statins, as well as diet and behavior modification.

ALLIANCE: Change in LDL cholesterol

            LDL cholesterol level Atorvastatin titrated to maximum 80 mg
(n=1146) Usual care (n=725)
            Mean initial LDL cholesterol (mg/dL) 147 146
            Mean final LDL cholesterol (mg/dL) 95 110
            Mean % change -34.3 -23.3

Koren noted that patients in both treatment arms were able to bring their LDL
cholesterol levels down, with 72% of atorvastatin patients and 40% of
usual-care patients achieving LDL cholesterol levels of less than 100 mg/dL.
Despite the usual-care patients starting with very high levels of LDL, they
achieved very significant cholesterol lowering, showing that "primary-care
doctors are able to bring down LDL cholesterol quite significantly in their
patients," said Koren. He added the cholesterol lowering occurred in both
groups, even though patients were not monitored as they have been in other
clinical trials.

Overall, treatment with atorvastatin resulted in a 17% reduction in the
primary composite end point compared with usual care (p=0.02), with the curves
separating at approximately one year. A reduction in the risk of nonfatal MI
was also observed, note investigators, with a 47% decrease in this secondary
end point in atorvastatin patients compared with usual care.

ALLIANCE: Percentage of primary outcome events

            End point Atorvastatin (n=1217) Usual care (n=1225) p
            Primary end point* (%) 23.7 27.2 0.02
            -Cardiac death (%) 3.5 5.0 0.059
            -Nonfatal MI (%) 4.3 7.7 0.0002
            -Resuscitated cardiac arrest (%) 0.2 0.4 NS
            -Cardiac revascularization (%) 16.2 18.4 0.08
            -Unstable angina requiring hospitalization (%) 10.4 12.0 NS

*Primary end point is a composite of cardiac death, nonfatal MI, resuscitated
cardiac arrest, cardiac revascularization, and unstable angina requiring
hospitalization

To download tables as slides, click on slide logo below

In their paper, Koren and colleagues write that future lipid guidelines should
consider the results of the ALLIANCE trial alongside other statin trials, such
as PROVE-IT and REVERSAL, both studies that demonstrated the superior benefit
of lipid lowering below current guidelines in high-risk patients. More
important, the guidelines should take into account use of "focused
disease-management techniques that helped patients in the atorvastatin group
meet NCEP goals nearly twice as often as patients in the usual-care group."

"One of the most important for clinicians to do is to set an LDL goal for
their patients, focus on it, and then select the most appropriate therapy to
bring their cholesterol down," Koren told heartwire.

            Source

              a.. Koren MJ, Hunninghake DB, on behalf of the ALLIANCE
investigators. Clinical outcomes in managed-care patients with coronary heart
disease treated aggressively in lipid-lowering disease management clinics. J
Am Coll Cardiol 2004; 44:1772-1779.

            Related links

              A to Z: Disappointing results for simvastatin 80 mg
              [HeartWire > Atherosclerosis; Aug 31, 2004]

              Experts react to the new NCEP ATP III guidelines: Many
anticipate further changes down the road
              [HeartWire > Atherosclerosis; Jul 16, 2004]

              Update to the NCEP ATP III guidelines recommends aggressively
treating LDL cholesterol levels in high-risk patients
              [HeartWire > Atherosclerosis; Jul 12, 2004]

              ALLIANCE: Aggressive LDL lowering in "real-world" setting
provides clinical benefit over usual care
              [HeartWire > Atherosclerosis; Mar 9, 2004]

              A "sea change" in the prevention of CVD: Experts discuss the
PROVE-IT trial
              [HeartWire > Atherosclerosis; Mar 8, 2004]

              REVERSAL: Atorvastatin 80 mg halts atheroma progression,
pravastatin 40 mg does not
              [HeartWire > News; Nov 12, 2003]

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