Mixed Results For Lipitor Vs. Zocor; Study Demonstrates Intensive LDL Cholesterol Lowering In Heart Disease Patients Can Reduce Cardiovascular Events, Pfizer Inc. Says

DALLAS, Nov. 15 /PRNewswire-FirstCall/ -- Patients who had a previous heart attack and took Pfizer Inc's cholesterol-lowering medicine Lipitor (atorvastatin calcium) to further lower their LDL or "bad" cholesterol levels had significantly fewer cardiovascular events including heart attacks, strokes or revascularization procedures compared to patients taking Zocor (simvastatin). Results of the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) study were presented today at the annual meeting of the American Heart Association. IDEAL is also published in this week's edition of the Journal of the American Medical Association.

There was an 11 percent reduction in major coronary events in Lipitor patients compared to Zocor patients. This difference did not reach statistical significance (p = .07). However, patients taking Lipitor experienced a significant 17 percent reduction in non-fatal heart attacks and a significant 13 percent reduction in major cardiovascular events compared to patients taking Zocor. Major cardiovascular events include heart disease- related death, heart attack, cardiac arrest, and stroke. Major coronary events consist of major cardiovascular events other than stroke. There were no significant differences in adverse events, including serious adverse events, between patients taking Lipitor and Zocor.

According to the World Health Organization (WHO), cardiovascular disease is the world's leading health threat, accounting for 16.7 million deaths worldwide. In the United States, over 60 million Americans are affected by cardiovascular disease and more than one million die of it annually. The burden on society, between the need for care and lost wages and work days, is considerable.

In the five-year study, 8,888 patients with an average age of 62 who had a previous heart attack, received either Lipitor (80 mg) or the most commonly prescribed doses of Zocor (20 mg to 40 mg) to determine whether more intensive lowering of LDL-cholesterol would provide additional cardiovascular benefits. Unlike prior statin trials, the majority of patients in IDEAL were already being treated with statins, beta-blockers, and aspirin prior to entering the study.

"The majority of IDEAL patients were taking multiple therapies to lower their cardiovascular risk prior to entering the trial," said Dr. Terje Pedersen, head of the Centre for Preventive Medicine at Ulleval University Hospital, Oslo Norway, and the lead investigator for IDEAL. "These results show us that intensive lipid lowering therapy with Lipitor can significantly reduce a patient's likelihood of experiencing another devastating event such as a heart attack or stroke, or the need for bypass surgery compared to patients taking standard Zocor therapy," said Dr. Terje Pedersen.

Dr. Pedersen was also the lead investigator in the landmark Scandinavian Simvastatin Survival Study (4S) trial involving Zocor which was the first statin trial to show mortality benefits of statins. Building on 4S, IDEAL shows that reductions in cardiovascular events with Lipitor provide benefits over and above the most commonly prescribed doses of Zocor (20 mg and 40 mg).The average LDL-cholesterol levels of participants entering the study was 122 mg/dL. Recent updated guidelines call for more aggressive LDL lowering to levels of less than 100 mg/dL in CHD patients. With intensive Lipitor therapy, patients were able to lower their LDL-cholesterol levels even further to an average of 81 mg/dL. This was significantly lower than patients taking Zocor, who had an average LDL-cholesterol level of 104 mg/dL.

"IDEAL results build upon the previous evidence shown in the TNT and PROVE-IT clinical trials that Lipitor's intensive lipid lowering can effectively and safely provide patients with cardiovascular benefits that are over and above other treatments," said Dr. Joseph Feczko, Pfizer's chief medical officer.

Since the introduction of Lipitor nearly nine years ago, its safety and effectiveness have been supported through an extensive clinical trial program, the Atorvastatin Landmark Program, with more than 400 ongoing and completed trials involving more than 80,000 patients. Lipitor is the most-prescribed cholesterol-lowering therapy in the world with more than 100 million patient years of experience.

Source: Pfizer Inc

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