Pfizer Inc announced that, in patients with heart disease, type 2 diabetes and chronic kidney disease, Lipitor (atorvastatin calcium) 80 mg significantly reduced the risk of major cardiovascular events, including heart attack and stroke, by 35 per cent compared with Lipitor 10 mg.
This finding is from a subanalysis designed and completed following the closure of the five-year Treating to New Targets (TNT) study in patients with existing coronary heart disease. The results were published in the August issue of Mayo Clinic Proceedings.
"As the rates of diabetes in the US have risen, we have seen a dramatic increase in the number of cases of chronic kidney disease," said Dr. James Shepherd, clinical academic consultant, department of pathological biochemistry, University of Glasgow Medical School and a member of the TNT steering committee. "This trend is alarming, since patients with diabetes and chronic kidney disease are much more likely to suffer a heart attack or stroke than patients with diabetes alone, increasing the urgency to treat. The study's findings support existing guidelines that recommend aggressively lowering LDL cholesterol using statin therapy, such as Lipitor 80 mg, to reduce the likelihood of a heart attack or stroke in these high-risk patients."
In patients with heart disease and type 2 diabetes but without chronic kidney disease, Lipitor 80 mg reduced the risk of major cardiovascular events by 10 percent compared to Lipitor 10 mg, which did not reach significance.
Both doses of Lipitor (80 mg and 10 mg) were generally well tolerated.
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.
The primary endpoint of the TNT study was the occurrence of a first major cardiovascular event, defined as death from heart disease, non-fatal heart attacks, resuscitated cardiac arrest, or fatal or non-fatal strokes.
This post-hoc subanalysis studied the effect of Lipitor 80 mg on the incidence of major cardiovascular events compared with Lipitor 10 mg in patients with heart disease and type 2 diabetes, with chronic kidney disease (n=546) and without chronic kidney disease (n=885). Patients with chronic kidney disease were defined as having a baseline glomerular filtration rate below 60 mL/min/1.73 m2 using a standard measure of kidney function. Lipitor 80 mg is not a starting dose.
Only Lipitor offers these three benefits important in a statin: FDA approval to reduce the risk of heart attacks, strokes and certain types of heart surgery in patients with cardiovascular risk or with heart disease; the ability to reduce "bad" cholesterol (LDL) by 39 percent to 60 percent; and a well-established safety profile across a broad range of patients.
It is the most prescribed branded cholesterol-lowering therapy in the world, with more than 151 million patient-years of experience. Lipitor is supported by a 16-year clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.