Note: This release was provided by Pfizer, Inc., the maker of Lipitor.
June 2003 - Pfizer Inc announced that the University College of London has announced preliminary results from a major study that showed diabetic patients who took its cholesterol-lowering medicine Lipitor had significantly fewer heart attacks, strokes and surgical procedures compared to patients who received placebo.
In the Collaborative Atorvastatin Diabetes Study (CARDS), roughly 2,800 patients with type-2 diabetes and no previous history of heart disease or stroke were treated with Lipitor (10 mg/day) or placebo to compare the effectiveness in reducing major coronary events, strokes or surgical revascularization procedures.
As a result of a significant benefit demonstrated by Lipitor, the independent steering committee of CARDS stopped the four-year study two years earlier than planned. All patients in the study have been notified and instructed to continue study drug until being contacted by their physician for one follow-up visit. Final results of the trial will be made public when available.
"These interim results clearly show a cardiovascular benefit in lowering cholesterol levels in patients with diabetes," said Dr. Joe Feczko, President for worldwide Development at Pfizer. "We are pleased that the efficacy and value of Lipitor continues to be demonstrated and look forward to reviewing the fully analyzed results."
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The CARDS study represents the second landmark Lipitor trial to end earlier than planned due to a significant benefit shown in patients taking the cholesterol-lowering medicine. Just eight months ago, the ASCOT trial was halted more than two years ahead of schedule. ASCOT results showed that patients with normal or slightly elevated cholesterol levels who took Lipitor had fewer fatal coronary events and non-fatal heart attacks than patients treated with placebo.
CARDS, which was initiated in the United Kingdom and Ireland, is a collaboration between Pfizer the University College of London, Diabetes UK, the largest Diabetes charity in the UK, and the Department of Health.
An estimated 100 million to 150 million people worldwide have been diagnosed with diabetes, though this figure is expected to double by 2010. Cardiovascular complications�especially coronary artery disease and stroke�are the most common cause of death in up to 75 percent of patients with type 2 diabetes.
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. A recent analysis of 44 worldwide clinical trials involving Lipitor further demonstrates the excellent safety and tolerability profile of Lipitor in a broad range of 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 be pregnant. Lipitor is not indicated for the prevention of heart disease or heart attacks.
Patients who take Lipitor should tell their doctor about any unusual muscle pain or weakness. This could be a sign of serious side effects. Patients should also inform their doctor 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.
Source: Pfizer Inc.
