Lipitor Significantly Reduced the Risk of Serious Cardiovascular Events Compared With Simvastatin in an 80,000-Patient Analysis of a Real-World Managed Care Database
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- Published on Monday, 05 March 2007 02:00
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BUENA VISTA, FL, USA | Mar 02, 2007 | A retrospective analysis of a large U.S. managed care database showed that patients who took Pfizer's cholesterol-lowering medicine Lipitor® (atorvastatin calcium) Tablets had a significant 14 percent reduction in the risk of cardiovascular events, including heart attacks and strokes, compared with patients who took simvastatin.
Today, physicians and healthcare plans are switching patients between what is believed to be comparable LDL-lowering doses of statins and assuming that this will result in similar cardiovascular benefits.
To replicate real-world physician and payor behavior, this study was rigorously designed to adjust for expected differences of Lipitor and simvastatin LDL lowering based on dose. Lipitor patients achieved a significant additional 14 percent reduction in the risk of cardiovascular events compared with patients taking simvastatin, even after the dose adjustments.
"This analysis is important for physicians, employers and formulary directors at managed care companies who are making real-world treatment decisions for patients," said Dr. Robert Vogel, an author of the study and professor of medicine at the University of Maryland. "This further supports the cardiovascular benefits previously seen with Lipitor."
"This study is significant because it calls into question whether statins should be prescribed interchangeably through simple dose adjustments," said Dr. Michael Berelowitz, senior vice president of Pfizer's global medical division.
The analysis was presented at the American Heart Association's 47th Annual Conference on Cardiovascular Disease Epidemiology and Prevention.
Confirms Previous Study
Netherlands analysis: In a previously published real-world study of a general practice database with approximately 3,500 patients in the Netherlands, characteristics such as age and cholesterol levels were measured and adjusted to account for differences among statins. This analysis demonstrated a similar finding to the analysis presented at the meeting. Patients taking Lipitor had a significant 30 percent reduction in the risk of total events compared with those taking other statins combined. Other statins included simvastatin, pravastatin, fluvastatin, and cerivastatin.
Given the results of these two studies, Pfizer will work with managed care organizations and other healthcare networks to further understand the benefit of Lipitor compared to simvastatin after adjustments to cholesterol levels.
Further Studies Planned
"Based on these important findings, it would be appropriate for health organizations responsible for lipid lowering formulary and treatment decisions to evaluate their own data and determine if they see similar findings," said Dr. Berelowitz. "We expect that there will be upcoming publications and expanded medical information that will continue to contribute to this important discussion around the benefits of Lipitor."
Key Points of the Analysis
Following are details of the analysis that showed the 14 percent event reduction:
* Patients in the analysis (61,324 taking Lipitor and 19,585 taking
simvastatin) had not used statins in the previous six months.
* The primary endpoint was defined as hospitalization due to a heart
attack, stroke, mini-stroke (transient ischemic attack), chest pain
(angina) or coronary artery disease, vascular disease, or certain types
of heart surgery.
* The primary endpoint was assessed after patients had been taking either
statin for at least three months.
* The median observation time was 177 days.
* To provide a rigorous comparison, the analysis adjusted for differences
in expected LDL lowering, prior cardiovascular events and baseline
characteristics between the treatment groups.
In a secondary analysis, which looked at event reduction from day one of Lipitor therapy, patients achieved a significant 26 percent cardiovascular risk reduction compared with patients who took simvastatin.
The differences in benefit for patients who took Lipitor was apparent early within the first three months and increased at a proportional rate during the observation period compared with patients who took simvastatin.
Lipitor is the only statin with all the following criteria most important for many physicians, patients and payers: significant and proven cardiovascular event reductions, impressive average LDL lowering of 39 percent to 60 percent, and a proven safety profile across a broad range of patients.
Lipitor is the most prescribed cholesterol-lowering therapy in the world, with nearly 133 million patient-years of experience. It is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients. There have been more than ten cardiovascular outcomes trials with more then 50,000 patients
Important US Prescribing Information
Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL ("good" cholesterol) or smoking to reduce the risk of heart attack, stroke, certain kinds of heart surgery, and chest pain. 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.
Patients taking Lipitor should tell their doctors if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctors about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.
For additional product information, visit http://www.lipitor.com/.
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SOURCE: Pfizer Inc