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Intensive Lipitor Therapy Reduced Heart Attack and Stroke By One-Third In Patients With Chronic Kidney Disease, New Analysis Shows.

* Patients with heart disease and chronic kidney disease who took intensive Lipitor therapy (80 mg) reduced their risk of heart attack and stroke by 32 percent compared with patients taking low-dose Lipitor (10 mg).

* An estimated 20 million Americans and 50 million people worldwide have chronic kidney disease. People with chronic kidney disease are more likely to die from heart disease than to develop kidney failure.

* Investigator: "These findings show that more aggressive treatment with Lipitor in patients with kidney disease can help reduce the risk of heart attack and stroke and improve measures of kidney function. The analysis suggests the expected decline in kidney function that occurred over time could be arrested with Lipitor 10 mg and, in fact, was reversed with Lipitor 80 mg therapy. This study is the first to show this type of dose-dependent effect with Lipitor."

CHICAGO, Nov. 15 /PRNewswire-FirstCall/ -- Results of a new analysis showed that patients who have heart disease and chronic kidney disease who took Lipitor(R) (atorvastatin calcium) Tablets (80 mg) reduced their risk of heart attack and stroke by 32 percent compared with patients taking the 10 mg dose of Lipitor. This analysis of a subset of patients from the five-year TNT (Treating to New Targets) study was designed and completed after the end of the trial. The data were presented here today at the Annual Scientific Sessions of the American Heart Association.

The primary endpoint of the TNT study was the reduction of major cardiovascular events, including death from heart disease, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes. The new analysis studied 3,107 patients with moderate to severe chronic kidney disease, as defined using a standard measure of kidney function. The efficacy results in this analysis were primarily driven by reductions in heart attack and stroke. Patients defined as having chronic kidney disease at the beginning of the TNT study experienced improvements in kidney function measurement with both Lipitor 10 mg and Lipitor 80 mg. Both doses of Lipitor were well tolerated.

"These findings show that more aggressive treatment with Lipitor in patients with kidney disease can help reduce the risk of heart attack and stroke and improve measures of kidney function," said Dr. James Shepherd, a member of the TNT steering committee and clinical academic consultant, department of pathological biochemistry, University of Glasgow Medical School. "The analysis suggests the expected decline in kidney function that occurred over time could be arrested with Lipitor 10 mg and, in fact, was reversed with Lipitor 80 mg therapy. This study is the first to show this type of dose- dependent effect with Lipitor."

An estimated 20 million Americans and 50 million people worldwide have chronic kidney disease, or permanent kidney damage due to injury or disease. Patients with chronic kidney disease do not effectively filter toxins from the blood. When chronic kidney disease progresses to kidney failure, either dialysis or a kidney transplant is needed. Chronic kidney disease recently has been recognized as an important risk factor for cardiovascular disease, the leading cause of death and illness in patients with kidney disease. People with chronic kidney disease are more likely to die from heart disease than to develop kidney failure.

"This analysis adds to the wealth of clinical information about how Lipitor can improve outcomes such as heart attack and stroke in treating a broad range of patients," said Dr. Michael Berelowitz, senior vice president, Pfizer Worldwide Medical. "Lipitor continues to show a well-established efficacy and safety profile in high-risk, as well as moderate- and low-risk patients."

"Patients with chronic kidney disease often take multiple medications for other conditions, so drug-drug interactions or dosing adjustments are important clinical considerations for patients and physicians," Dr. Berelowitz added. "The National Kidney Foundation guidelines state that there are no dosing adjustments required for Lipitor in patients with impaired renal function. Therefore the results of this sub-analysis are extremely important for this high-risk patient population."

Heart disease is the leading cause of death in the United States, and the majority of Americans with elevated cholesterol, a leading risk factor for heart attacks, are not at their recommended cholesterol goal levels. Updated guidelines issued by the National Cholesterol Education Program recommend treatment with cholesterol-lowering medications like Lipitor, along with diet modification and exercise, for patients at risk for cardiovascular disease.

About TNT (Treating to New Targets) Study

The TNT study was a landmark investigator-led trial coordinated by an independent steering committee and funded by Pfizer. It was the largest study to date evaluating the efficacy and safety of Lipitor 80 mg. The study enrolled 10,001 men and women with coronary heart disease aged 35 years to 75 years in 14 countries and followed them for an average of five years.

About Lipitor

Lipitor is the most prescribed cholesterol-lowering therapy in the world, with nearly 127 million patient-years of experience. Lipitor is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.

Important US Prescribing Information

Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL ("good" cholesterol) or smoking to reduce the risk of heart attack and stroke. When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.

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

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 taking Lipitor should tell their doctors if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctors about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.

For additional product information, visit http://www.lipitor.com/.

CONTACT: Vanessa Aristide, +1-212-733-3784, or Rebecca Hamm, +1-212-733-8811, or +1-917-599-7752

Web site: http://www.pfizer.com/ http://www.lipitor.com/

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