Pfizer's Lipitor (atorvastatin calcium) 80 mg reduced the risk of heart attack and stroke by 32 per cent in patients who have heart disease and chronic kidney disease compared with patients taking the 10 mg dose of Lipitor, according to a five-year Treating to New Targets (TNT) study.
"People with chronic kidney disease are more likely to die from heart disease than to develop kidney failure," said Dr. James Shepherd, a member of the TNT steering committee and clinical academic consultant, department of pathological biochemistry, University of Glasgow Medical School. "It is critical for us to find new ways to reduce cardiovascular burden in these patients. Intensive statin therapy seems to be at least part of the solution."
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. This sub-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. Both doses of Lipitor (80 mg and 10 mg) were well tolerated. Lipitor 80 mg is not a starting dose. The safety of Lipitor 80 mg in patients with chronic kidney disease was similar to that reported for the overall TNT population, with no unexpected safety concerns identified.
"The results of this analysis complement the large body of evidence from multiple clinical trials demonstrating the cardiovascular benefits of Lipitor," said Halit Bander, Ph.D. senior director, Pfizer's global cardiovascular metabolic medical team.
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. The safety of Lipitor 80 mg in patients with chronic kidney disease was similar to that reported for the overall TNT population, with no unexpected safety concerns identified.
Lipitor is the only statin proven to provide a combination of impressive average LDL ("bad" cholesterol) lowering of 39 per cent to 60 per cent, significant and proven cardiovascular event reductions, and a well-established safety profile across a broad range of patients.
It is the most prescribed cholesterol-lowering therapy in the world, with nearly 151 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.