Patients with coronary heart
disease (CHD) and elevated cholesterol who took Pfizer Inc's cholesterol-
lowering medicine Lipitor (atorvastatin calcium) experienced improved kidney
function, and those improvements were significantly greater among patients
taking the highest dose (80 mg). The data, from an analysis of nearly 8,000
patients from the Treating to New Targets (TNT) trial, were presented today at
the 55th Annual Scientific Session of the American College of Cardiology and
published online in the Journal of the American College of Cardiology.
An estimated 20 million Americans suffer from chronic kidney disease (CKD).
In people with CKD, the kidneys cannot effectively filter the toxins from the
blood, which can lead to kidney failure. People with elevated total
cholesterol and high LDL cholesterol, or "bad" cholesterol are often at an
increased risk of developing kidney dysfunction.
"We anticipated that atorvastatin might provide a protective effect and
slow the typical decline in kidney function in this patient population, but we
didn't expect to see this level of improvement," said Dr. James Shepherd, TNT
steering committee member and clinical academic consultant, Department of
Pathological Biochemistry, University of Glasgow Medical School.
The analysis assessed eGFR, or estimated glomerular filtration rate at the
beginning and end of the five-year TNT clinical trial. eGFR is used to
measure kidney function -- patients with eGFR of less than 60 mL/min are
considered to have chronic kidney disease (CKD). eGFR naturally declines with
age. Patients in the TNT study did not experience a decline in eGFR --
patients taking Lipitor 10 mg experienced an improvement in kidney function
(5.6 percent) and patients taking Lipitor 80 mg experienced a highly
significant increase in kidney function (8.5 percent). Fifty percent of
patients taking Lipitor 80 mg were no longer classified as having chronic
kidney disease.
TNT was an investigator-led trial coordinated by an independent steering
committee and funded by Pfizer. The study enrolled men and women between 35
and 75 years of age in 14 countries. Demographic characteristics for the
patients included in this current analysis were similar to the overall TNT
population and were well balanced between treatment groups.
Lipitor is the most prescribed cholesterol-lowering therapy in the world,
with nearly 107 million patient-years of experience.
It is used, in patients with multiple risk factors for heart disease such
as family history, high blood pressure, age, low HDL cholesterol or smoking,
to reduce the risk of heart attack or stroke and, along with a low-fat diet,
to lower cholesterol.
Lipitor is also used in patients with type 2 diabetes and one other risk
factor such as high blood pressure, smoking, or other complications of
diabetes, including eye disease and protein in urine, to reduce the risk of
stroke and heart attack.
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 who take Lipitor should tell their doctor about any unusual
muscle pain or weakness. This could be a sign of serious muscle side effects.
Patients should tell their doctor about all the medicines they take. This may
help avoid serious drug interactions. Doctors should do blood tests to check
patients' liver function before and during drug treatment, and may adjust the
dose of Lipitor. Its most common side effects are gas, constipation, stomach
pain, and heartburn. They tend to be mild and often go away.
Pfizer Inc
pfizer
Lipitor