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Title: Atorvastatin Confirmed as Safe in Older Patients at Increased Cardiovascular Risk: Presented at AAN

"Atorvastatin Confirmed as Safe in Older Patients at Increased Cardiovascular Risk: Presented at AAN"

By Jill Stein BOSTON, MA -- May 1, 2007 -- New data suggest that doctors should not hesitate to use atorvastatin in older patients at increased cardiovascular risk (CVD) because of concern about the drug's safety. The results, announced here on May 1[^st at the American Academy of Neurology 59^th Annual Meeting (AAN), show that the frequency of adverse effects in patients who were 75 years of age or more does not increase with the atorvastatin dose and is similar to those seen in placebo-treated patients and in younger patients.

Judith Hey-Hadavi, medical director, clinical research and development, Pfizer Global Pharmaceuticals, New York, New York, presented the results of a pooled analysis of 2128 patients 75 years or older, who were participants in 54 completed, randomized atorvastatin trials.

"Increased age is associated with increased risk for CVD including stroke," Dr. Hey-Hadavi observed. "People aged 75 years of age or older are more likely to die from CVD than from cancer. Most new coronary heart disease events occur in people aged 65 years of age or older. Because elderly people have a higher attributable risk of coronary heart disease as a result of hypercholesterolemia, more overall events can be prevented via treatment in this age group than in younger people with hypercholesterolemia."

In statin trials of the secondary coronary-event prevention, older patients showed significant risk reduction with therapy. The National Cholesterol Education Program supports the use of statins for intensive lipid-lowering therapy in older patients with or without established CVD, she continued. However, most trial participants were 65 to 75 years of age, and with the aging population, the number of patients 75 years of age or older is increasing.

It has been suggested that concern regarding adverse events and drug interactions in older patients might be among the reasons why doctors are reluctant to prescribe statins in this age group, Dr. Hey-Hadavi noted.

In her study, Dr. Hey-Hadavi and colleagues enrolled male and female patients of different ethnic backgrounds with varying degrees of CVD risk. Patients were randomized to placebo, atorvastatin 10 mg, 20 mg, 40 mg, and 80 mg.

The overall adverse effect profile for placebo and all atorvastatin groups were similar. The most frequently reported side effects related to treatment involved the digestive system (< 11% in all groups).

Persistent elevation of liver function greater than 3 x ULN was seen in 2 patients (0.6%), 2 patients (0.5%), 0, 0, and 8 patients (0.9%) in the placebo, atorvastatin 10 mg, 20 mg, 40 mg, and 80 mg groups, respectively. Persistent creatine phosphokinase elevations (> 10 x ULN) were not observed in any group

Serious adverse effects rarely led to treatment cessation.

Dr. Hey-Hadavi said the results document that atorvastatin is safe across the full dose range.

The study was supported by Pfizer, Inc.

[Presentation title: Atorvastatin Safety in Patients 75 Years and Older. Abstract P01.102]

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