News | March 18, 2010

Intensive Statin Use Shows Reduced Risk of Cardiovascular Events in High-Risk Patients

March 18, 2010 — New data from two subanalyses of the Treating to New Targets (TNT) trial showed an increased dose of atorvastatin calcium (Lipitor), lowered cardiovascular events among high-risk patients with both coronary heart disease (CHD) and chronic kidney disease (CKD) who were obese or had metabolic syndrome.

The results were presented this week at the 59th annual scientific session of the American College of Cardiology (ACC) in Atlanta. Atorvastatin calcium 80 mg was associated with a significantly reduced risk of major cardiovascular events compared with 10 mg.

“Nearly 26 million Americans suffer from CKD, which is often associated with comorbidities — such as heart disease, metabolic syndrome or obesity — that can increase risk for heart attack and stroke,” said Prakash Deedwania, M.D., professor of medicine, UCSF School of Medicine, San Francisco and chief, cardiology section, VACCHCS/UCSF Program, Fresno, Calif. “The new data presented at ACC demonstrate that Lipitor 80 mg may help prevent cardiovascular events in these high-risk patients.”

According to the new analyses, for patients with both CHD and CKD, being obese or having metabolic syndrome may further increase their risk for cardiovascular events.

In one sub-analysis, which looked at the 1,859 patients in TNT who had CHD, CKD and metabolic syndrome, atorvastatin calcium 80 mg was associated with a 35 percent reduction in the risk of major cardiovascular events compared with 10 mg. In a separate sub-analysis of the 954 patients in TNT with CHD, CKD and obesity, 80 mg was associated with a 33 percent reduction in the risk of major cardiovascular events compared with 10 mg. For both subanalyses, major cardiovascular events included a combined endpoint of death from heart disease, nonfatal heart attack, resuscitated cardiac arrest and fatal or nonfatal stroke.

The safety of atorvastatin calcium in these patient subsets was consistent with that in the overall TNT trial. Atorvastatin calcium is not approved for the treatment of CKD, obesity or metabolic syndrome.

The original TNT study was an investigator-led trial coordinated by an independent steering committee and funded by Pfizer. The study enrolled 10,001 men and women with coronary heart disease ages 35 years to 75 years in 14 countries, and followed them for an average of five years. After an eight-week run-in on atorvastatin calcium 10 mg, patients were randomized to receive either atorvastatin calcium 10 mg or 80 mg. Primary study results were published in The New England Journal of Medicine in 2005.

The primary endpoint of the original TNT study was the time to occurrence of a first major cardiovascular event, defined as death from heart disease, non-fatal heart attack, resuscitated cardiac arrest, or fatal or non-fatal stroke.

Atorvastatin calcium 80 mg is not a starting dose. The drug is not approved in all countries to reduce the risk of cardiovascular events in patients with existing heart disease. Throughout the TNT study, atorvastatin calcium was generally well tolerated.

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