New Lipitor Data Published in The Lancet
New York (ots/PRNewswire)
- Lipitor Reduces Risk of Major Cardiovascular Events Such as Heart Attacks in People With Heart Disease and With a Cluster of Other Major Cardiovascular Risk Factors, Often Referred to as Metabolic Syndrome, New Analysis Shows
- Heart Disease Patients With Metabolic Syndrome who Took Lipitor 80mg Dose Reduced Their Risk of Major Cardiovascular Events by Nearly 30 Percent - Study Investigator: 'This is the largest analysis conducted in patients on a statin with pre-existing heart disease and metabolic syndrome. These data support the urgency of intensive LDL lowering to prevent cardiovascular events in this very high risk patient population.'
A combination of risk factors that includes abdominal obesity, low "good" cholesterol (HDL), high blood pressure and elevated blood sugar occurs in nearly one in four Americans and places them at increased risk for cardiovascular events, including heart attacks and stroke. This combination of risk factors, which has been referred to as metabolic syndrome, adds to the risk for cardiovascular events already associated with high "bad" cholesterol (LDL).
New data published this week in the online version of The Lancet show that in patients with pre-existing heart disease who also had a specific cluster of cardiovascular risk factors, consistent with the metabolic syndrome, intensive treatment with Lipitor 80mg reduced their chances of having a heart attack or stroke. This is the largest analysis conducted to assess heart disease patients who have metabolic syndrome and have taken statins.
According to this secondary analysis, patients with heart disease and metabolic syndrome who took the Lipitor 80mg dose reduced their risk of major cardiovascular events such as heart attacks by nearly 30 percent compared with those who remained on the lower dose of Lipitor 10mg. Both Lipitor 80mg and Lipitor 10mg were well-tolerated in this patient population over the follow-up period of nearly 5 years.
These findings are from an analysis of 5584 patients with heart disease and who met National Cholesterol Education Program (NCEP)-based criteria for metabolic syndrome from the Treating to New Targets (TNT) trial of more than 10,000 patients. These findings are consistent with the overall results of the TNT study, which demonstrated the cardiovascular benefits of lowering cholesterol levels to well below recommended levels with Lipitor 80mg in patients with coronary heart disease, compared to lowering cholesterol to within the minimum recommended levels with Lipitor 10mg.
"This is the largest analysis conducted in patients on a statin with pre-existing heart disease and metabolic syndrome. These data support the urgency of intensive LDL lowering to prevent cardiovascular events in this very high-risk patient population," said Dr. Prakash C Deedwania, investigator for the Treating to New Targets (TNT) study, Chief, Cardiology Division, Veterans Administration Medical Center/UCSF program at Fresno, and Professor of Medicine, UCSF School of Medicine, San Francisco.
This analysis also illustrated that in TNT, patients with metabolic syndrome were more likely to experience a major cardiovascular event than those without these risk factors. In addition, the analysis showed that every additional cardiovascular risk factor increased a patient's risk of experiencing a cardiovascular event. Patients who had a higher number of risk factors and received intensive treatment with Lipitor 80mg had fewer cardiovascular events compared with patients taking the Lipitor 10mg dose.
TNT was an investigator-led trial sponsored by Pfizer.
Important Information about Lipitor:
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 ("good" cholesterol), 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. For more product information visit http://www.Lipitor.com or call +1-888-LIPITOR.
Note to News Media:
- Study investigators will be available to discuss the TNT analysis in
more detail
- This analysis will be published in the online version of The Lancet on
Tuesday, September 5, 2006
Web site: http://www.pfizer.com
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