Pfizer says Lipitor 80 mg showed significant risk reduction in patients with heart disease - update

(RTTNews) - Tuesday, healthcare company Pfizer Inc. (PFE | Quote | Chart | News | PowerRating) said a subanalysis of the five-year Treating to New Targets, or TNT, study showed that Lipitor, or atorvastatin calcium, 80 mg significantly reduced the relative risk of suffering a first cardiovascular event by 19% in patients with established heart disease compared with Lipitor 10 mg. This subanalysis, designed and completed following the closure of the TNT study, also showed that Lipitor 80 mg provided a sustained reduction in the risk of a subsequent second, third, fourth, and fifth cardiovascular event.

The New York-based company presented the subanalysis findings at the 2008 European Society of Cardiology Congress in Munich, Germany.

Atorvastatin, a member of the drug class known as statins, is used for lowering cholesterol. Under the brand name Lipitor, it is one of the largest selling drugs in the world.

A cardiovascular event is defined as death from heart disease, non-fatal heart attack, resuscitated cardiac arrest, certain types of heart surgery, procedure-related heart attack, chest pain, fatal or non-fatal stroke, peripheral arterial disease or hospitalization due to chronic heart failure. These events were chosen as the endpoint for the post-hoc subanalysis.

The TNT study, funded by Pfizer, was an investigator-led trial coordinated by an independent steering committee. The study enrolled 10,001 men and women with coronary heart disease aged between 35 years and 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.

The subanalysis of the TNT study showed a 21% relative risk reduction in a subsequent second cardiovascular event and a 24% relative risk reduction in a subsequent third cardiovascular event. The subanalysis also indicated a 28% relative risk reduction in a subsequent fourth cardiovascular event and a 29% relative risk reduction in a subsequent fifth cardiovascular event. The endpoint for the subanalysis was any cardiovascular event.

Commenting on the subanalysis, Dr. John LaRosa, president and professor of medicine at the State University of New York Downstate Medical Center in Brooklyn, New York, and a member of the TNT steering committee, said, "The original TNT trial, as with most cardiovascular outcome trials, only evaluated the time to a patient's first cardiovascular event and therefore may not have fully accounted for the total clinical benefits achieved by intensive LDL-cholesterol lowering."

"This subanalysis is important because patients with heart disease often go on to suffer more than one cardiovascular event." "These findings suggest that patients can benefit from long-term therapy with high dose Lipitor," LaRosa noted.

Earlier today, Pfizer and Bristol-Myers Squibb Co. (BMY | Quote | Chart | News | PowerRating) announced the results of a Phase 2 dose-ranging study, involving the investigational compound apixaban in patients with acute coronary syndrome, or ACS, commonly known as heart attack or severe chest pain. The incidence of the primary endpoint of this safety study, major bleeding plus clinically relevant non-major bleeding, was remarkably higher at 7.9% for patients who took the 10 mg once daily dose compared to 3.0% for patients who took placebo.

Last month, Pfizer and Bristol-Myers reported that a Phase III trial of apixaban for the prevention of venous thromboembolism, or VTE, in patients undergoing total knee replacement did not meet the primary endpoint of the study. The companies also said that the U.S. regulatory filing for the anti-clot drug in the prevention of VTE will not be submitted in the second half of 2009 as previously indicated.

PFE is trading at $19.42, up $0.31, on a volume of 8.08 million shares.

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