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New Data Analysis Shows Patients With Diabetes Taking Pfizer's Lipitor(R) Experienced Major Reductions in Heart Attack and Stroke

Posted on: Monday, 13 June 2005, 09:00 CDT

SAN DIEGO, June 13 /PRNewswire-FirstCall/ -- Data presented today at the annual meeting of the American Diabetes Association show that patients with diabetes and coronary heart disease (CHD) who took Pfizer Inc's cholesterol-lowering medicine Lipitor and lowered their cholesterol to well below recommended levels experienced significantly fewer heart attacks and strokes than those who lowered their cholesterol to achieve recommended levels.

The findings are from a post-hoc analysis that involved 1,500 people with heart disease and diabetes and an LDL, or "bad" cholesterol level of <130 mg/dL from the five-year Treating to New Targets Trial (TNT). In the analysis, patients who received atorvastatin 80 mg experienced 25 percent fewer cardiovascular events, including CHD death, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes, compared to patients who took atorvastatin 10 mg. By the end of the study, LDL cholesterol levels were significantly lower in the 80 mg group (~77 mg/dL) compared to the 10-mg group (99 mg/dL).

"These data are the first to demonstrate the CV benefits of lowering LDL beyond recommended guidelines with atorvastatin 80 mg in this high-risk diabetic population. Moreover, patients achieved these results without additional muscle risks," said James Shepherd, MD, Clinical Academic Consultant Department of Pathological Biochemistry, University of Glasgow Medical School, Glasgow, UK.

The main TNT study and the post-hoc analysis of patients with diabetes demonstrated that the musculoskeletal safety profile of atorvastatin 80 mg was comparable to atorvastatin 10 mg, and the incidence of repeat liver enzyme elevations in both groups was within product labeling. TNT is the longest study to date of atorvastatin 80 mg efficacy and safety.

More than 18 million American adults have diabetes, a leading risk factor for cardiovascular disease that results in a four-fold increased chance of suffering a heart attack or stroke than in adults without diabetes. The American Diabetes Association estimates that about 65 percent of deaths among people with diabetes are due to heart disease and stroke.

In the 2004 update to The National Cholesterol Education Program (NCEP) guidelines, it was reaffirmed that diabetes is an equivalent risk to established heart disease because the risk of suffering a cardiovascular event, such as a heart attack or stroke, is the same between people with diabetes and those without diabetes who have already suffered a first heart attack or stroke. In fact, treatment guidelines from the American Diabetes Association recommend that adults with type 2 diabetes should be considered for statin therapy regardless of their LDL-C levels.

According to the NCEP guidelines update, patients with diabetes should be treated to the same cholesterol goals as patients with established heart disease -- an LDL-C <100 mg/dL. The update to the guidelines also suggested that in patients with diabetes and cardiovascular disease, an LDL-C goal of <70 mg/dL is a therapeutic option.

This recent update also affirmed the potential added benefit of prescribing cholesterol-lowering medication, along with diet and exercise, to patients at risk for cardiovascular disease, such as those with diabetes and heart disease.

"The results seen with 80 mg of atorvastatin in the TNT post-hoc analysis are even more impressive because, unlike in placebo-controlled trials, the reductions are beyond those already seen in the active treatment arm of this study with 10 mg of atorvastatin," said Gregg Larson, PhD, vice president, Pfizer Medical.

TNT was an investigator-led trial coordinated by an independent steering committee and was funded by Pfizer. The study enrolled men and women between 35 and 75 years of age in 14 countries.

The TNT study is part of the Atorvastatin Landmark Program, an extensive clinical trial program with more than 400 ongoing and competed trials involving more than 80,000 patients.

Lipitor is a prescription drug used to reduce the risk of heart attack in patients with multiple risk factors including: high blood pressure, age 55 or older, smoking, family history or low levels of good cholesterol, and, with a low-fat diet, to lower cholesterol.

Lipitor is not for everyone including those with liver problems or women who are nursing, pregnant, or may become pregnant. Lipitor patients should tell their doctor if they feel any new muscle pain or weakness which could be a sign of serious side effects. Patients should tell their doctor about all the medicines they take. This may help avoid serious drug interactions. Doctors should perform 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 which tend to be mild and often go away.

For full prescribing information, log on to http://www.lipitor.com/ or call 1-888-LIPITOR.

Photo: A free corporate logo to accompany this story is availableimmediately via Wieck Photo Database to any media with telephoto receiver orelectronic darkroom, PC or Macintosh, that can accept overhead transmissions.To retrieve a logo, please call 972-392-0888.

Pfizer Inc

CONTACT: Samina Bari of Pfizer Inc, +1-212-733-0126

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

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Source: PRNewswire-FirstCall

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