Penn researchers study how atorvastatin treats symptoms of peripheral arterial disease

November 20, 2002

(PHILADELPHIA. PA) -- Investigators of the TREADMILL study report the findings of the first randomized, double-blind study to examine the effects of moderate and aggressive lipid lowering therapy using atorvastatin on the symptoms of peripheral arterial disease (PAD). Conducted over a period of one year, in a small number of patients as a proof-of-concept study, the trial did not reach the primary efficacy parameter of improved walking performance; however, the secondary study endpoints demonstrated significant improvement of two common symptoms of PAD (pain-free walking distance and community-based physical activity.

The study "Treatment of peripheral Atherosclerotic Disease with Moderate or Intensive Lipid Lowering" (or "TREADMILL") was sponsored by Pfizer and followed a total of 364 patients who were randomly assigned to atorvastatin 10 mg, atorvastatin 80 mg or placebo. The study was conducted in 22 sites in the United States and Canada. The results showed no significant improvement in the primary endpoints of maximal walking time in the three groups after 12 months of treatment. The TREADMILL study did show that patients treated with both 10 mg and 80 mg of atorvastatin experienced significant improvement in two of the secondary efficacy parameters of PAD (pain-free walking distance and community-based physical activity) and lipid profile levels compared with patients in the placebo group.

"Although the primary endpoint was not met, we are encouraged by what we learned from the secondary objectives, in that patients experienced significant quality of life improvements," said Emile Mohler, MD, of the University of Pennsylvania School of Medicine, one of three researchers in the TREADMILL study. Further studies are needed to confirm and expand upon the beneficial effects of statins in the treatment of PAD.

PAD is a common manifestation of atherosclerotic disease of the lower limbs that occurs in 2.5% of patients aged less than 60 years and in up to 18.8% of patients aged over 70 years. PAD is a progressive disease in which leg arteries that are narrowed or blocked by atherosclerosis deliver less blood and oxygen to the legs and feet. This reduced blood supply may result in leg pain, sores that do not heal, and even amputations.

Atorvastatin calcium tablets is a prescription drug used with diet to lower cholesterol, it is not indicated to treat or prevent heart disease. It is not for everyone, including those with liver disease or possible liver problems, women who are nursing, pregnant or may become pregnant. Patients who take atorvastatin calcium should tell their doctors about any unusual muscle pain or weakness. This could be a sign of serious side effects. Patients should also inform their doctors about any medications they are currently taking to avoid possible serious drug interactions.

Prescribing physicians may do simple blood tests to monitor liver function before and during drug treatment. The most commonly reported side effects are gas, constipation, stomach pain and indigestion. They are usually mild and tend to go away.

The study was funded by a grant from Pfizer, and Dr. Mohler is a member of Pfizer's Speaker's Bureau.

University of Pennsylvania School of Medicine

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