Approval of cholesterol-lowering therapy Lipitor for the prevention of cardiovascular disease

Aug 5 2004

Pfizer has announced that the U.S. Food and Drug Administration has approved its cholesterol-lowering therapy Lipitor® (atorvastatin calcium) for the prevention of cardiovascular disease by reducing heart attack risk in people with normal to mildly elevated cholesterol levels who have other cardiovascular risk factors.

The FDA's decision was based on the findings of the landmark ASCOT trial (Anglo-Scandinavian Cardiac Outcomes Trial), which found that the lowest dose of Lipitor (10 mg) reduced the relative risk of heart attack by 36 percent compared to placebo. Because these significant benefits were seen so early, the trial was ended nearly two years ahead of schedule.

"No other lipid-lowering agent has shown an effect as dramatic as Lipitor in terms of reducing cardiovascular disease and in offering this significant health benefit as fast as Lipitor," said Dr. Joseph Feczko, Pfizer's President of Worldwide Development. "Lipitor clearly is different in its early ability to reduce heart attacks among a very broad population of patients, regardless of cholesterol levels."

Another Lipitor study also ended two years ahead of schedule and also demonstrated Lipitor's early cardiovascular benefits to patients. The CARDS study (Collaborative Atorvastatin Diabetes Study), the largest study ever designed to evaluate a statin in diabetics, showed that patients with diabetes who took Lipitor had 48 percent fewer strokes than those who received placebo. In addition, Lipitor-treated patients had significantly fewer fatal and non-fatal heart attacks and required fewer surgical procedures.

Heart disease is the leading cause of death in the United States, and most Americans with elevated cholesterol, a leading risk factor for heart attacks, are either not diagnosed or have not reached their target LDL levels with medication. "People are suffering heart attacks and dying unnecessarily," Dr. Feczko said. "With Lipitor, we have a medicine that can significantly reduce cardiovascular disease for millions of patients."

Lipitor also is the first lipid-lowering agent to demonstrate superior cardiovascular benefits when compared to another statin in two separate studies. In the REVERSAL study, Lipitor halted the progression of atherosclerosis, or hardening of the arteries, while the other statin merely slowed progression. Pfizer has either submitted these additional studies to the FDA or plans to do so shortly for inclusion in the product's prescribing information.

In the PROVE-IT study, patients taking Lipitor had a significantly lower cardiovascular events rate than patients taking a different statin. PROVE-IT was conducted by the Bristol-Myers Squibb Co.

"It's becoming increasingly clear that Lipitor provides cardiovascular benefits beyond simply lowering LDL cholesterol," Dr. Feczko said. "Lowering LDL levels with statin therapy has been shown to reduce death and disability, but based on recent studies, we now know that Lipitor provides earlier and greater benefits than lowering LDL alone."

With starting doses of 10 mg, 20 mg or 40 mg, 98 percent of patients taking Lipitor reach their target LDL goal level. Updated guidelines recently 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. The NCEP panel cited the ASCOT trial as one of the landmark studies instrumental in concluding the revision of the guidelines.

Every year, more than 865,000 Americans suffer heart attacks. High blood pressure and elevated cholesterol are the leading risk factors for heart disease but other factors compound the risk, including family history of heart disease, age over 55, smoking, diabetes, obesity and lack of exercise. Direct (medical costs) and indirect (lost productivity) costs related to coronary heart disease are expected to exceed $133 billion this year.