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Lipitor OK'D to Prevent Strokes in Diabetics Study Shows Those Taking the Cholesterol-Lowering Drug Had Fewer Strokes.

Posted on: Wednesday, 12 October 2005, 18:00 CDT

By CHERIE BLACK

The U.S. Food and Drug Administration Tuesday approved cholesterol-lowering medicine Lipitor to reduce the risk of stroke and heart attack in some diabetes patients.

The new medication is for patients who don't exhibit symptoms of heart disease but show a substantial risk of contracting the disease.

The FDA's decision was based on the findings of a clinical trial that ended in 2004 involving more than 2,800 patients with type 2 diabetes, healthy cholesterol levels and at least one other risk factor, such as high blood pressure.

The study showed that patients who took Lipitor suffered nearly 50 percent fewer strokes than those who used a placebo.

The additional approval of Lipitor for stroke patients stemmed from a separate study of more than 10,000 people that found the medication reduced the risk of stroke by 26 percent. The study participants had normal or borderline cholesterol and no prior history of heart disease. They also had controlled high blood pressure and at least three other risk factors for heart disease.

Some studies have questioned Lipitor's effectiveness and point to serious side effects such as liver problems. Samer Garas, an interventional cardiologist at St. Vincent's Medical Center, said Lipitor is a safe drug and its benefit outweighs its risk.

"With FDA approval of expanded indications, hopefully this increases awareness to treat diabetes patients more aggressively," Garas said.

"We treat diabetics as if they've already had a heart attack or stroke because they have the same risk factors," he said. "This is a great thing for patients."

More than 18 million Americans suffer from diabetes, which is a leading risk factor for cardiovascular disease. About 65 percent of people with diabetes will suffer a heart attack or stroke. In Jacksonville, one out of five people is at risk or already has been diagnosed with diabetes, Garas said. All would be candidates for Lipitor, he said.cherie.black@jacksonville.com, (904) 359-4504

Source: Florida Times Union

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