The lipid-lowering agent Lipitor has been given a new indication from the U.S. Food and Drug Administration (FDA). Lipitor’s manufacturer, Pfizer, Inc., has announced that Lipitor will also be used to reduce the risk of stroke and heart attack in people with type 2 diabetes without evidence of heart disease but with other risk factors.
The FDA granted its decision after findings of the Collaborative Atorvastatin Diabetes Study (CARDS) were reported. In the trial, which involved more than 2,800 patients with type 2 diabetes, patients on Lipitor experienced nearly 50 percent fewer strokes than those on placebo. Pfizer reports that the CARDS trial was stopped nearly two years early “because of the strong benefits among patients who took Lipitor.”
“With this FDA approval, we’re pleased that a broad range of patients, in addition to effectively lowering their cholesterol with Lipitor, will be able to derive the significant cardiovascular benefit of reducing their chances for suffering a stroke or heart attack,” says Gregg Larson, PhD, Pfizer’s U.S. medical vice president.
For additional information about Lipitor, visit www.lipitor.com or call (888) LIPITOR or (888) 547-4867.
Source: Pfizer, Inc.
Pfizer warns that Lipitor is not indicated for people with liver problems, nor is it indicated for women who are nursing or pregnant or who may become pregnant.
“If you take Lipitor, tell your doctor if you feel any unusual muscle pain or weakness,” says a spokesperson for Pfizer. “This could be a sign of serious muscle side effects.”
The most common side effects of Lipitor are gas, constipation, stomach pain and heartburn. Side effects tend to be mild and often go away on their own.
Source: Pfizer, Inc
Common risk factors for heart disease include high cholesterol, high blood pressure, family history, being over age 55, smoking, diabetes and obesity.