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Lipitor Demonstrates Improvement in Kidney Function in Patients With Coronary Heart Disease, New Analysis Shows

ATLANTA, G.A. -- March 13, 2006 -- Patients with coronary heart disease (CHD) and elevated cholesterol who took Pfizer Inc's cholesterol- lowering medicine Lipitor (atorvastatin calcium) experienced improved kidney function, and those improvements were significantly greater among patients taking the highest dose (80 mg).

The data, from an analysis of nearly 8,000 patients from the Treating to New Targets (TNT) trial, were presented today at the 55th Annual Scientific Session of the American College of Cardiology and published online in the Journal of the American College of Cardiology.

An estimated 20 million Americans suffer from chronic kidney disease (CKD). In people with CKD, the kidneys cannot effectively filter the toxins from the blood, which can lead to kidney failure. People with elevated total cholesterol and high LDL cholesterol, or "bad" cholesterol are often at an increased risk of developing kidney dysfunction.

"We anticipated that atorvastatin might provide a protective effect and slow the typical decline in kidney function in this patient population, but we didn't expect to see this level of improvement," said Dr. James Shepherd, TNT steering committee member and clinical academic consultant, Department of Pathological Biochemistry, University of Glasgow Medical School.

The analysis assessed eGFR, or estimated glomerular filtration rate at the beginning and end of the five-year TNT clinical trial. eGFR is used to measure kidney function -- patients with eGFR of less than 60 mL/min are considered to have chronic kidney disease (CKD). eGFR naturally declines with age. Patients in the TNT study did not experience a decline in eGFR -- patients taking Lipitor 10 mg experienced an improvement in kidney function (5.6 percent) and patients taking Lipitor 80 mg experienced a highly significant increase in kidney function (8.5 percent). Fifty percent of patients taking Lipitor 80 mg were no longer classified as having chronic kidney disease.

TNT was an investigator-led trial coordinated by an independent steering committee and funded by Pfizer. The study enrolled men and women between 35 and 75 years of age in 14 countries. Demographic characteristics for the patients included in this current analysis were similar to the overall TNT population and were well balanced between treatment groups.

Lipitor is the most prescribed cholesterol-lowering therapy in the world, with nearly 107 million patient-years of experience.

It is used, in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL cholesterol or smoking, to reduce the risk of heart attack or stroke and, along with a low-fat diet, to lower cholesterol.

Lipitor is also used in patients with type 2 diabetes and one other risk factor such as high blood pressure, smoking, or other complications of diabetes, including eye disease and protein in urine, to reduce the risk of stroke and heart attack.

Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant, or may become pregnant.

Patients who take Lipitor should tell their doctor about any unusual muscle pain or weakness. This could be a sign of serious muscle side effects. Patients should tell their doctor about all the medicines they take. This may help avoid serious drug interactions. Doctors should do blood tests to check patients' liver function before and during drug treatment, and may adjust the dose of Lipitor. Its most common side effects are gas, constipation, stomach pain, and heartburn. They tend to be mild and often go away.


SOURCE: Pfizer Inc

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