November 14, 2008

Pfizer Reports Positive Findings From Sub-Analysis of Lipitor Study

Pfizer has reported positive findings from a post hoc sub-analysis of the five-year Treating to New Targets study. According to the company, improvements in kidney function in patients treated with Lipitor were shown to strongly correlate with a reduced risk of major cardiovascular events in patients with pre-existing cardiovascular disease.

In this new post hoc analysis, kidney function was assessed using estimated glomerular filtration rate (eGFR), as recommended by the National Kidney Foundation. Increases in eGFR indicate improved kidney function.

Findings from this new analysis showed that in patients with heart disease treated with Lipitor, for each 1mL/min/1.73sqm increase in eGFR there was a 2.7% relative reduction in risk of major cardiovascular events.

According to the company, similar risk reductions per 1mL/min/1.73sqm increase in eGFR were observed for secondary endpoints such as major coronary events, nonfatal heart attack and fatal or nonfatal stroke. Throughout the Treating to New Targets (TNT) study, both doses of Lipitor (10 and 80mg) 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 original 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.

Rochelle Chaiken, vice president of Pfizer's cardiovascular and metabolic medical division, said: "This analysis is exciting because it suggests a potential additional benefit of Lipitor - improving kidney function while reducing cardiovascular events."