Two New Imaging Studies Show Higher Dose Lipitor Stopped the Progression of Atherosclerosis

Business Wire, March 26, 2007

RADIANCE 1

In patients with a genetic condition known as familial hypercholesterolemia resulting in extremely high LDL levels randomized to Lipitor, progression of atherosclerosis was halted. Patients took an average dose of 56 mg of Lipitor (n=427). There was no significant change from baseline in the IMT of the 12 carotid segments (0.0053mm/yr) nor in the common carotid artery (-0.0014mm/yr).

RADIANCE 2

Patients with high LDL and high triglycerides randomized to Lipitor experienced a progression of atherosclerosis. Patients took an average low, 13 mg dose of Lipitor (n=344). There was a significant change from baseline in the IMT of the 12 carotid segments (0.0296mm/yr) and a small but statistically significant change in the common carotid artery (0.0076mm/yr).

About the Overall SPARCL Study

The SPARCL study, published in the New England Journal of Medicine in 2006, is the only study to date evaluating the benefits of a statin solely in patients with a prior stroke or mini-stroke (n=4,731). Lipitor 80 mg reduced the risk of an additional stroke by 16 percent and major coronary events by 35 percent compared with placebo. In a post-hoc analysis of the SPARCL trial, there was a higher incidence of hemorrhagic stroke in patients taking Lipitor 80 mg compared with patients taking placebo. Patients with prior hemorrhagic stroke at study entry appeared to be at an increased risk of hemorrhagic stroke.

In SPARCL, Lipitor was well-tolerated. The rate of side effects such as elevated liver enzymes, muscle weakness or rhabdomyolysis were low and consistent with the known safety profile.

Important U.S. 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 a heart attack, stroke, certain types of heart surgery and chest pain.

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 used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, and chest pain. Lipitor is not indicated for atherosclerosis.

When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.

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.