and at least one other risk factor, such as high blood pressure or smoking. CARDS showed that patients using Lipitor experienced 48% fewer strokes than those on placebo. The CARDS study’s steering committee stopped the trial nearly two years earlier than planned because of the clinical benefits among patients who took Lipitor.

In addition, the FDA expanded the Lipitor label to include data on the reduction in the incidence of stroke in patients with multiple risk factors, as shown in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) clinical trial. The ASCOT trial found that Lipitor reduced the relative risk of stroke by 26% compared to placebo. The study involved people with normal or borderline cholesterol and no prior history of heart disease with controlled high blood pressure and at least three other risk factors for heart disease, such as family history, age over 55, smoking, diabetes, and obesity. Patients with multiple risk factors, including diabetes, face a greater threat of heart attack and stroke. Reducing their risk of such cardiovascular events is extremely important.

In March 2005, the Treating to New Targets (TNT) clinical study/ trial was presented at the American College of Cardiology meeting and was published simultaneously in the New England Journal of Medicine. TNT was the first large-scale study to show that patients with established coronary disease who reduce and maintain their cholesterol with Lipitor well below currently recommended levels experience significantly fewer heart attacks and strokes than those who lower their cholesterol to recommended levels. The results of TNT, the longest and largest study to date of Lipitor 80 mg efficacy and safety, were achieved safely and build upon the well-established safety profile of Lipitor’s highest dose. Over the course of the following eight months, a total of eight TNT sub-group analyses were presented at the scientific sessions of the American Heart Association and American Diabetes Association, further demonstrating the efficacy and safety of long-term therapy with Lipitor 80 mg in specific patient populations.

The recently published IDEAL study, involving 8,888 patients with established coronary heart disease, assessed the efficacy of Lipitor 80 mg for secondary prevention of cardiovascular events compared with simvastatin (Zocor) 20/40 mg. On the primary endpoint, reduction in the risk of a major coronary event, Lipitor 80 mg achieved an 11% risk reduction compared with simvastatin 20/40 mg. This difference fell short of statistical significance, however (p=0.07 vs. significance at p=0.05). Lipitor achieved statistically significant improvements in major secondary endpoints compared with simvastatin, including a 13% reduction in major cardiovascular events and a 17% reduction in non-fatal heart attacks.

In December 2005, the U.S. District Court for the District of Delaware determined that two U.S. patents covering atorvastatin, the active ingredient in Lipitor, are valid and infringed by the product of generic manufacturer Ranbaxy Laboratories Limited, thus protecting Lipitor’s exclusivity until June 2011. In addition, in October 2005, the United Kingdom’s