31st Mar 2009 07:00
Among patients aged 65 and older with established coronary heart disease, Lipitor® (atorvastatin calcium) 80 mg significantly reduced the relative risk of a first cardiovascular event by 23 percent and provided significant reductions in the risk of subsequent second, third and fourth cardiovascular events over a period of five years compared to Lipitor 10 mg, according to data presented today at the 58th annual scientific sessions of the American College of Cardiology (ACC) in Orlando, FL. This post hoc sub-analysis was designed and completed following the Treating to New Targets (TNT) study.
"More people are surviving heart attacks than ever before due to improved healthcare," said Dr. Nanette Wenger, professor of medicine, division of cardiology, Emory University School of Medicine. "But anyone who experiences one cardiovascular event remains at increased risk for additional events. Age further increases this risk. This sub-analysis showed that in the TNT study intensive Lipitor therapy provided sustained reductions in the risk of multiple cardiovascular events in an older population with coronary heart disease."
The American Heart Association estimates that 470,000 Americans will have a recurrent heart attack this year. Most cardiovascular outcomes trials, including the overall TNT trial, however, evaluate only the time to a patient's first cardiovascular event and thus may underestimate potential longer-term effects of treatment. This sub-analysis evaluated any cardiovascular event during the full duration of the five-year TNT study in 3,809 patients aged 65 and older with stable coronary heart disease. Any cardiovascular event was defined as death from heart disease, non-fatal heart attack, resuscitated cardiac arrest, revascularization procedure, procedure-related heart attack, chest pain, fatal or non-fatal stroke, peripheral arterial disease or hospitalization due to chronic heart failure.
In this study, Lipitor 80 mg demonstrated the following risk reductions compared to Lipitor 10 mg:
a significant 23 percent relative risk reduction in a first cardiovascular event a significant 25 percent relative risk reduction in a subsequent second cardiovascular event a significant 30 percent relative risk reduction in a subsequent third cardiovascular event a significant 33 percent relative risk reduction in a subsequent fourth cardiovascular event a 22 percent relative risk reduction in a subsequent fifth cardiovascular event, which did not reach statistical significanceAlthough the original TNT study was not designed to look at subsequent cardiovascular events beyond the first CV event, these results suggest sustained risk reductions with Lipitor 80 mg compared with Lipitor 10 mg in this patient population.
Throughout the overall TNT study, both doses of Lipitor were generally well tolerated.
About the TNT Study
The TNT study was an investigator-led trial coordinated by an independent steering committee and funded by Pfizer. The study enrolled 10,001 men and women with coronary heart disease aged 35 years to 75 years in 14 countries and followed them for an average of five years. Primary study results were published in The New England Journal of Medicine in 2005.
The primary endpoint of the original TNT study was the occurrence of a first major cardiovascular event, defined as death from heart disease, non-fatal heart attack, resuscitated cardiac arrest, or fatal or non-fatal stroke.
The endpoint for this sub-analysis of older patients was any cardiovascular event, defined as death from heart disease, non-fatal heart attack, resuscitated cardiac arrest, revascularization procedure, procedure-related heart attack, chest pain, fatal or non-fatal stroke, peripheral arterial disease or hospitalization due to chronic heart failure.
Lipitor 80 mg is not a starting dose.
Important U.S. 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 and stroke, certain kinds of heart surgery and chest pain. 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 used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, 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 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 www.Lipitor.com.
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