Pfizer Inc said that initial results from a major clinical trial involving its cholesterol-lowering medicine Lipitor (atorvastatin calcium) showed that Lipitor provided a significant benefit in reducing fatal and non-fatal heart attacks as well as strokes.

The study, known as the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) involving nearly 20,000 patients with high blood pressure, was designed to compare the effects of newer anti-hypertensive medicines with standard therapies in reducing cardiac events. In addition, half of the patients enrolled received either a 10 mg dose of Lipitor or placebo to measure the effects of lowering cholesterol in patients who had high blood pressure and cholesterol levels that were normal or slightly elevated.

As a result of a significant benefit demonstrated by Lipitor, the independent ASCOT steering committee has decided to stop the Lipitor portion of the study. All patients in the study will be notified and instructed to contact their physician for appropriate follow-up. Final results of the Lipitor portion of the study will be made public when available.

"These initial results from the ASCOT study suggest a clear cardiovascular benefit from diligently lowering cholesterol levels in this particular population of patients with high blood pressure," said Dr. Joe Feczko, President of Worldwide Development at Pfizer. "We are pleased that evidence continues to mount that further supports the efficacy and value of Lipitor."

Funded by Pfizer, ASCOT is an investigator-led trial coordinated by an independent steering committee. The study, which is ongoing, began in 1998 and has enrolled patients in the United Kingdom, Ireland, Sweden, Norway, Denmark, Finland and Iceland. Study participants were required to have hypertension and at least three other risk factors, such as being 55 years of age or older, smoking or having diabetes.

Between 35 per cent and 50 per cent of patients with high blood pressure also suffer from high cholesterol, and vice versa. However, research has shown that patients with high blood pressure are more likely to be treated for their condition than are patients with high cholesterol. It is estimated that up to 150 million people worldwide with high cholesterol are either not diagnosed or not meeting their cholesterol goals with treatment.

Patients in the ASCOT study who received Lipitor had total cholesterol levels up to 250 mg/DL. Generally, it is not standard practice in Europe to treat patients without a previous cardiac event at this level with cholesterol-lowering medicines.

Since its introduction six years ago, the safety and efficacy of Lipitor has been supported through an extensive clinical trial program with more than 400 ongoing and completed trials involving more than 80,000 patients.

Lipitor (atorvastatin calcium) tablets is a prescription drug used with diet to lower cholesterol. Lipitor is not indicated to treat or prevent heart disease. Lipitor is not for everyone, including those with liver disease or possible liver problems, women who are nursing, pregnant, or may become pregnant.