Patients with Diabetes Taking Lipitor Experienced Major Reductions in Heart Attacks and Strokes

Main Category: Diabetes
Article Date: 07 Jun 2004 - 18:00 PST

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Second Landmark Lipitor Trial to End Earlier than Expected due to Significant Cardiovascular Benefit for Patients.



Orlando, Florida, USA - Pfizer Inc's cholesterol-lowering medicine Lipitor significantly reduced heart attacks and strokes in patients with diabetes, according to data presented from the largest study specifically designed to study a statin in this patient population. Results were presented today at the annual meeting of the American Diabetes Association.

In the Collaborative Atorvastatin Diabetes Study (CARDS), which involved more than 2,800 patients with type-2 diabetes, no history of heart disease, and relatively-low levels of cholesterol, patients who took Lipitor had a 37 percent reduction in major cardiovascular events, which included heart attacks, stroke, chest pain that required hospitalization, cardiac resuscitation, and coronary revascularization procedures. In addition, 48 percent fewer Lipitor treated patients experienced strokes compared to those who received placebo, and the overall mortality rate for Lipitor patients was 27 percent lower than for those on placebo.

The CARDS study was stopped nearly two years earlier than planned because of the significant benefits among patients who took Lipitor compared with those who received placebo. CARDS, which was initiated in the United Kingdom and Ireland, is a collaboration between Pfizer, University College London, Diabetes UK, the largest Diabetes charity in the UK, and the UK Department of Health.

The CARDS study was the second landmark Lipitor study to end early due to a significant cardiovascular benefit seen in patients. The Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA) was the first Lipitor study to end early due to a significant benefit in hypertensive patients with normal or mildly elevated cholesterol levels.

"This important study has demonstrated that lowering cholesterol with atorvastatin in patients with diabetes-even those whose LDL, or 'bad' cholesterol levels, were relatively low-will result in a dramatic cardiovascular benefit," said Professor Helen Colhoun, CARDS co-principal investigator, University College Dublin, Ireland. "The benefit was so great that the trial had to be terminated early-CARDS demonstrates that statin therapy can be of great benefit to the vast majority of diabetes patients, and that atorvastatin is highly effective and safe."

An estimated 170 million people worldwide suffer from diabetes, which is a leading risk factor for cardiovascular disease. The majority of people with diabetes-roughly 65 percent-will suffer a heart attack or stroke, a rate that is up to four times higher than in adults without diabetes.

"The CARDS data add to the growing body of evidence that support the early and significant cardiovascular benefits of treating patients with Lipitor," said Dr. Joseph Feczko, Pfizer's executive vice president of Global Research and Development and president of Worldwide Development. "Patients with diabetes who have relatively-low cholesterol levels have been shown to benefit from treatment with Lipitor."

According to the American Diabetes Association recommended treatment guidelines, adults with type-2 diabetes should be considered for statin therapy regardless of their LDL levels. In addition, European cholesterol guidelines also set more aggressive cholesterol goals for patients with diabetes, and recommend that patients with diabetes be treated to the same cholesterol goals as patients with established heart disease.

Separately, in the Analysis and Understanding of Diabetes and Dyslipidemia: Improving Treatment (AUDIT) survey of 2,000 diabetes specialists in 50 countries, these doctors said that while 90 percent of patients with diabetes are screened regularly for cholesterol levels, only half actually achieve their target cholesterol goal. The survey, presented at the American Diabetes Association annual meeting, also noted that physicians do not always regard diabetes patients as being equivalent in terms of cardiovascular risk to patients with established CHD, as recognized by the NCEP ATP III guidelines which recommend similar cholesterol goals for patients with diabetes and patients with CHD.

Type-2 diabetes is increasing at epidemic proportions worldwide, and experts attribute this growth to genetics, obesity and lack of exercise.

"Access to effective and clinically proven cholesterol-lowering treatment such as Lipitor is critical to improving the health and longevity of patients with diabetes," Dr. Feczko said.

Since the introduction of Lipitor seven years ago, its safety and effectiveness have been and continue to be supported through the Atorvastatin Landmark Program, the most extensive statin clinical program to date with more than 400 ongoing and completed trials involving more than 80,000 patients. Lipitor is the leading cholesterol-lowering therapy in the world with an established record of trust among physicians and patients worldwide and nearly 72 million patient years of experience.

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

If you take Lipitor, tell your doctor about any unusual muscle pain or weakness. This could be a sign of serious muscle side effects. It is important to tell your doctor about any medications you are currently taking to avoid possible serious drug interactions. Your doctor should do simple blood tests to monitor liver function before and during drug treatment and may adjust your dose. The most commonly reported side effects are gas, constipation, stomach pain and indigestion. They are usually mild and tend to go away.