Lipitor improves kidney function in clinical trial
(Reuters)
Mon Mar 13th 2006 at 9:10 pm ET
NEW YORK (Reuters) - Pfizer Inc. on Monday said its Lipitor cholesterol medicine improved kidney function in patients with heart disease in a large clinical study.
The drugmaker also said improvement in kidney function was significantly greater among patients taking the 80 milligram highest dose of Lipitor, the world's top-selling prescription drug.
The data, which came from further analysis of a study into aggressive cholesterol lowering that was unveiled a year ago, was presented at the American College of Cardiology annual scientific meeting in Atlanta.
Fifty percent of patients who took the 80 mg dose of Lipitor, known chemically as atorvastatin, were no longer classified as having chronic kidney disease, Pfizer and researchers said.
"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," Dr. James Shepherd of the University of Glasgow Medical School, who was involved in the study, said in a statement.
The secondary analysis looked at 8,000 patients from the five-year study that originally compared the effects of low dose Lipitor to high-dose Lipitor.
People with high cholesterol are often at an increased risk of developing kidney dysfunction, a condition in which the kidneys cannot effectively filter toxins from the blood that can eventually lead to kidney failure.
Patients who took the 10 mg lowest dose of Lipitor experienced a modest 5.6 percent improvement in kidney function, researchers said.
The 80 mg patients experienced an 8.5 percent increase in kidney function, which researchers involved with the Pfizer- funded study called "highly significant."
The safety of Lipitor 80 mg in the study was similar to that reported for the study's overall population, with no unexpected safety concerns identified, Pfizer said.