"Intensive lipid-lowering therapy with 80 mg of atorvastatin per day in patients with stable CHD provides significant clinical benefit beyond therapy with 10 mg of atorvastatin per day,

The five-year Treating to New Targets Trial (TNT) involved 10,000 patients with established coronary heart disease and elevated LDL, or "bad" cholesterol levels. The study assessed whether high-dose Lipitor (atorvastatin calcium) patients who aggressively lowered their LDL-cholesterol levels to well below the current guidelines (100 mg/dL) would experience additional cardiovascular benefits compared to Lipitor patients who maintained their LDL-cholesterol at recommended levels.

More Lipitor, Fewer Heart Attacks, Strokes

Patients who received 80 mg doses of Lipitor had 22 percent fewer cardiovascular events, including CHD death, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes compared to patients who took 10 mg of Lipitor. In addition, patients treated with high-dose Lipitor had 25 percent fewer fatal or non-fatal strokes compared to those treated with just 10 mg of Lipitor.

The TNT study demonstrated that the musculoskeletal safety profile of Lipitor at 80 mg dosing was comparable to Lipitor 10 mg doses. The incidence of liver enzyme elevations in both groups was within existing product labeling. TNT is the longest and largest study to date of Lipitor 80 mg efficacy and safety.

"Previous clinical trials, including ASCOT and CARDS, have shown the outstanding ability of Lipitor 10 mg to safely get patients to their goal levels and reduce their risk of cardiovascular events," said Dr. Joseph Feczko, Pfizer's chief medical officer. "TNT is the very first study to demonstrate even greater cardiovascular benefits of lowering LDL beyond recommended guidelines with Lipitor 80 mg. Patients achieved these results safely, and Lipitor 80 mg was well tolerated."

Benefits Achieved Safely

"Intensive lipid-lowering therapy with 80 mg of atorvastatin per day in patients with stable CHD provides significant clinical benefit beyond therapy with 10 mg of atorvastatin per day," TNT investigators conclude in their report published in the March 8 online issue of the New England Journal of Medicine,

Patients entered the study with LDL-cholesterol levels between 130 mg/dL and 250 mg/dL. More than half of the patients taking Lipitor at 10 mg doses achieved LDL-cholesterol levels of 100 mg/dL or lower.

TNT is an investigator-led trial coordinated by an independent steering committee and was funded by Pfizer. The study enrolled men and women between 35 and 75 years of age in 14 countries.

"In addition to providing outstanding benefits at the lowest and highest doses of Lipitor in the TNT study, it's important to note that patients achieved these benefits safely," Dr. Feczko said. "This is critical new information that potentially could have a significant impact on how physicians approach the treatment of heart disease."

Diet Modification and Exercise Important

Coronary heart disease is the leading cause of death in the United States, and the majority of Americans with elevated cholesterol, a leading risk factor for heart attacks, are not at their recommended goal levels.

Updated guidelines issued by the National Cholesterol Education Program confirm the added benefit of prescribing cholesterol-lowering medication like Lipitor, along with diet modification and exercise, to patients at risk for cardiovascular disease. In addition, the NCEP panel has recommended an LDL-cholesterol level of less than 100 mg/dL as the goal of therapy for patients at high risk of coronary heart disease.

Since the introduction of Lipitor nine years ago, its safety and efficacy have been supported through an extensive clinical trial program with more than 400 ongoing and completed trials involving more than 80,000 patients, says Pfizer. Lipitor is the most prescribed cholesterol-lowering therapy in the world, the company states, with nearly 100 million patient years of experience.

Lipitor is a prescription drug. It is used with a low-fat diet to lower cholesterol and reduce the risk of heart attack in patients with multiple risk factors -- such as high blood pressure, age 55 or older, smoking, family history of cardiovascular disease or low levels of good cholesterol, according to Pfizer.