Healthcare Industry News:  dementia 

Biopharmaceuticals Cardiology

 News Release - June 9, 2006

Pfizer Statement on Lipitor

NEW YORK, June 9 (HSMN NewsFeed) -- In response to publicity generated by one plaintiff's attorney that may have created undue concerns for Lipitor patients and unnecessary confusion for health care professionals, Pfizer issued the following statement that underscores the proven efficacy and safety of Lipitor.

"To create undue concern and doubt about Lipitor is a real disservice to health care professionals who prescribe Lipitor and the patients who depend on Lipitor to reduce heart disease, which is the leading cause of death in the United States and around the world," said Dr. Michael Berelowitz, Pfizer Worldwide Medical.

Introduced in the United States in 1997, Lipitor is one of the most extensively studied medicines in history. Its safety record is very well established. By a 3 to 1 ratio, cardiologists would choose Lipitor over the next leading statin to treat a family member, based on a recent survey.

* More than 400 completed and ongoing clinical trials have been conducted in over 80,000 patients.

* Moreover, in the last five years alone, more than 22 million patients have taken Lipitor in the United States.

* Around the world, 120 million patient years of experience with Lipitor have been accumulated.

Of particular note to patients, the American Heart Association and the American College of Cardiology have just published new treatment guidelines for patients at high risk for heart disease. These guidelines strongly support the use of statins such as Lipitor to reduce cholesterol and decrease cardiovascular disease.

An extensive series of published clinical data shows the safety and efficacy of Lipitor.

* Recently, analyses of the safety of Lipitor over its dose range were published in the American Journal of Cardiology, a peer-reviewed journal, derived from analysis of 49 completed trials in 14,236 patients.

No causal relationship has been observed between Lipitor and dementia, or between Lipitor and peripheral neuropathy, even in studies of Lipitor in patient populations such as Alzheimer's disease and diabetes. In fact, the Lipitor clinical data accumulated in these areas is unmatched by any other statin medicine.

In the case of Lipitor, the prescribing information reflects the context of Lipitor's benefits and highlights Lipitor's role in preventing heart attacks and strokes.

The economic benefits of Lipitor were shown in a recently published analysis of the IDEAL (Incremental Decrease in Endpoints Through Aggressive Lipid Lowering) trial. This analysis showed that one out of every six heart attacks, strokes and cardiovascular procedures could be avoided for heart disease patients treated with intensive Lipitor 80 mg therapy versus standard dose Zocor. This study analyzed the cost effectiveness of treatment with Lipitor and Zocor (simvastatin) in Sweden, where Zocor is available generically as simvastatin. The IDEAL patients who received Lipitor (80 mg) achieved greater reductions in heart attacks, strokes and cardiovascular procedures compared to patients taking standard dose Zocor (20-40 mg).

Statins as a class have also been extensively studied.

* An analysis conducted by the Cholesterol Treatment Trialists' Collaborators, and published in the Lancet, evaluated 14 randomized statin trials and 90,056 participants. The analysis concluded that statin therapy can safely reduce the 5-year incidence of major coronary events, coronary revascularisation, and stroke by about one fifth per mmol/L reduction in LDL cholesterol.

* Again, no causal relationship has been observed between statins and dementia or peripheral neuropathy.

Pfizer rigorously collects and provides all available safety information about Lipitor, as it does for all its medicines, to regulatory agencies worldwide, where a full assessment is made.

The regulatory assessment is then described in the prescribing information for the medicine allowing physicians to make an appropriate judgment about the use of the medicine based on the patient's history and medical condition.

Pfizer intends to vigorously challenge in court all the baseless claims made in these lawsuits.

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Lipitor is a prescription drug. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL or smoking to reduce the risk of heart attack and stroke. When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.

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 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.

If you take Lipitor, tell your doctor if you feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Tell your doctor about all medications you take. This may help avoid serious drug interactions. Your doctor should do blood tests to check your liver function before and during treatment and may adjust your dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.

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Source: Pfizer

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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