Lipitor Patients Who Reduced "Bad" Cholesterol to Very Low Levels Show Significant Decrease in Heart Attack and Stroke, Data Show

Main Category: Cholesterol
Article Date: 10 Mar 2005 - 0:00 PDT

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Patients taking both high and low doses of Lipitor experienced fewer cardiovascular events; patients on high-dose Lipitor had significantly fewer events than those on lower dose.

Patients with coronary heart disease who took Pfizer Inc's cholesterol-lowering medicine Lipitor (atorvastatin calcium) and lowered their cholesterol to well below recommended levels experienced significantly fewer heart attacks and strokes than those who only lowered their cholesterol to recommended levels, according to data presented here today at the annual meeting of the American College of Cardiology.

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 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.

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."

According to the March 8 online issue of the New England Journal of Medicine, TNT investigators concluded that "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."

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."

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 competed trials involving more than 80,000 patients, Lipitor is the most prescribed cholesterol-lowering therapy in the world with nearly 100 million patient years of experience.

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

Lipitor is not for everyone. It is not for those with liver problems or for women who are nursing, pregnant, or may become pregnant. Lipitor patients should tell their doctor if they feel any new muscle pain or weakness which could be a sign of serious side effects. Patients should tell their doctor about all the medicines they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain, and heartburn. They tend to be mild and often go away.

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