* Patients with heart disease and chronic kidney disease who took intensive
Lipitor therapy (80 mg) reduced their risk of heart attack and stroke by 32
percent compared with patients taking low-dose Lipitor (10 mg).
* An estimated 20 million Americans and 50 million people worldwide have
chronic kidney disease. People with chronic kidney disease are more likely
to die from heart disease than to develop kidney failure.
* Investigator: "These findings show that more aggressive treatment with
Lipitor in patients with kidney disease can help reduce the risk of heart
attack and stroke and improve measures of kidney function. The analysis
suggests the expected decline in kidney function that occurred over time
could be arrested with Lipitor 10 mg and, in fact, was reversed with
Lipitor 80 mg therapy. This study is the first to show this type of
dose-dependent effect with Lipitor."
CHICAGO, Nov. 15 /PRNewswire-FirstCall/ -- Results of a new analysis
showed that patients who have heart disease and chronic kidney disease who
took Lipitor(R) (atorvastatin calcium) Tablets (80 mg) reduced their risk
of heart attack and stroke by 32 percent compared with patients taking the
10 mg dose of Lipitor. This analysis of a subset of patients from the
five-year TNT (Treating to New Targets) study was designed and completed
after the end of the trial. The data were presented here today at the
Annual Scientific Sessions of the American Heart Association.
The primary endpoint of the TNT study was the reduction of major
cardiovascular events, including death from heart disease, non-fatal heart
attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes. The
new analysis studied 3,107 patients with moderate to severe chronic kidney
disease, as defined using a standard measure of kidney function. The
efficacy results in this analysis were primarily driven by reductions in
heart attack and stroke. Patients defined as having chronic kidney disease
at the beginning of the TNT study experienced improvements in kidney
function measurement with both Lipitor 10 mg and Lipitor 80 mg. Both doses
of Lipitor were well tolerated.
"These findings show that more aggressive treatment with Lipitor in
patients with kidney disease can help reduce the risk of heart attack and
stroke and improve measures of kidney function," said Dr. James Shepherd, a
member of the TNT steering committee and clinical academic consultant,
department of pathological biochemistry, University of Glasgow Medical
School. "The analysis suggests the expected decline in kidney function that
occurred over time could be arrested with Lipitor 10 mg and, in fact, was
reversed with Lipitor 80 mg therapy. This study is the first to show this
type of dose- dependent effect with Lipitor."
An estimated 20 million Americans and 50 million people worldwide have
chronic kidney disease, or permanent kidney damage due to injury or
disease. Patients with chronic kidney disease do not effectively filter
toxins from the blood. When chronic kidney disease progresses to kidney
failure, either dialysis or a kidney transplant is needed. Chronic kidney
disease recently has been recognized as an important risk factor for
cardiovascular disease, the leading cause of death and illness in patients
with kidney disease. People with chronic kidney disease are more likely to
die from heart disease than to develop kidney failure.
"This analysis adds to the wealth of clinical information about how
Lipitor can improve outcomes such as heart attack and stroke in treating a
broad range of patients," said Dr. Michael Berelowitz, senior vice
president, Pfizer Worldwide Medical. "Lipitor continues to show a
well-established efficacy and safety profile in high-risk, as well as
moderate- and low-risk patients."
"Patients with chronic kidney disease often take multiple medications
for other conditions, so drug-drug interactions or dosing adjustments are
important clinical considerations for patients and physicians," Dr.
Berelowitz added. "The National Kidney Foundation guidelines state that
there are no dosing adjustments required for Lipitor in patients with
impaired renal function. Therefore the results of this sub-analysis are
extremely important for this high-risk patient population."
Heart disease is the leading cause of death in the United States, and
the majority of Americans with elevated cholesterol, a leading risk factor
for heart attacks, are not at their recommended cholesterol goal levels.
Updated guidelines issued by the National Cholesterol Education Program
recommend treatment with cholesterol-lowering medications like Lipitor,
along with diet modification and exercise, for patients at risk for
cardiovascular disease.
About TNT (Treating to New Targets) Study
The TNT study was a landmark investigator-led trial coordinated by an
independent steering committee and funded by Pfizer. It was the largest
study to date evaluating the efficacy and safety of Lipitor 80 mg. 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.
About Lipitor
Lipitor is the most prescribed cholesterol-lowering therapy in the
world, with nearly 127 million patient-years of experience. Lipitor is
supported by an extensive clinical trial program involving more than 400
ongoing and completed trials with more than 80,000 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 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.
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.
SOURCE Pfizer Inc
back to top
Related links: http://www.pfizer.com http://www.Lipitor.com
Photo Notes:A free corporate logo to accompany this story is availableimmediately via Wieck Photo Database to any media with telephoto receiveror electronic darkroom, PC or Macintosh, that can accept overheadtransmissions. To retrieve a logo, please call 972-392-0888./ /Company News On-Call: http://www.prnewswire.com/comp/688250.html
Pfizer's press releases are available through PR Newswire's Company News On-Call service on PRN's Web Site. Visit http://www.prnewswire.com/comp/688250.html/
CONTACT: Vanessa Aristide, +1-212-733-3784, or Rebecca Hamm, +1-212-733-8811, or +1-917-599-7752
|