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Popular Cholesterol Drug Helps Patients With Arterial Leg Pain

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Popular Cholesterol Drug Helps PAD Patients

Popular Cholesterol Drug Helps Patients With Arterial Leg Pain

September 10, 2003

By Stephanie Riesenman for Veins1

For thousands of Americans over age 60, a weekend stroll is no walk in the park. Not only are they at risk for heart disease, but walking-induced leg pain can also put a cramp in their day. Currently, treating pain and preventing heart attacks involves popping several pills. But a new study found that Lipitor—prescribed to lower cholesterol—might offer the dual benefit of easing leg pain while protecting the heart.

The condition known as intermittent claudication is characterized by sharp pain, cramping, or numbing in the legs or buttocks that occurs while walking or exercising, but goes away with rest. The illness that causes this pain in the legs also causes heart attacks and strokes. Peripheral arterial disease (PAD) can affect any artery in the body, but when there is a blockage in the arteries that supply blood to the legs, often the result is intermittent claudication.

"A drug that not only improves claudication symptoms but also reduces cardiovascular events would be a particularly useful therapy for patients with PAD," the researchers write in the current issue of Circulation, a journal of the American Heart Association.

The statin drug Lipitor was recently studied in 354 adults with intermittent claudication to see if it increased the distance patients could walk and reduce the amount of leg pain they experience while moving. Lead investigator Dr. Mark Creager, of Brigham and Women’s Hospital in Boston, along with colleagues at two other medical centers, conducted the research. The study was funded by Pfizer, the manufacturer of Lipitor.

During the study, patients were advised not to take any other lipid-modifying drugs or drugs prescribed to treat PAD. However, aspirin was recommended, and all were counseled on a low-cholesterol diet.

Patients were assigned to take either 10 milligrams of Lipitor—the lowest prescribed dose to reduce cholesterol, 80 milligrams of Lipitor—the highest prescribed dose to lower cholesterol, or a placebo. Neither the investigators nor the patients knew which medication they were taking.

After a year, the patients were given a walking test on a treadmill to see how long they could walk compared to tests taken before the study began. Results showed no difference between the three study medications in regards to how long each patient could walk on a treadmill.

However, the amount of time patients could walk before the onset of leg pain increased by 63 percent for patients taking 80 milligrams of Lipitor. Pain-free walking also increased slightly for patients taking 10 milligrams of Lipitor and for those on a placebo.

The researchers claim that the "change in pain-free walking time is comparable to that achieved with other currently approved pharmacotherapies." Those drugs include the brand names Pletal and Trental, which alleviate pain by increasing the amount of oxygen that reaches the tissues in the legs.

However, the researchers also point out that the time it takes for Lipitor to produce improvement in claudication symptoms seems to be longer than with the currently approved drugs. So patients with leg pain, "should not expect symptomatic improvement in pain free walking time after weeks, but more likely after months of treatment," they write.

As expected, researchers also found that patients taking either dose of Lipitor had reductions in their total cholesterol, LDL (bad) cholesterol, and triglycerides, while their HDL (good) cholesterol went up. And those taking the medication also showed improvement in overall physical activity according to responses in a questionnaire.

The researchers discuss three possible mechanisms for how this cholesterol-lowering drug reduces the symptoms of claudication. They suggest Lipitor might work by shrinking the size of the fatty plaques inside the arteries, improving blood flow within the vessels, or promoting the growth of new blood vessels.

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