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(atorvastatin, Pfizer Inc.)

The lipid-lowering drug approved for five new indications in adults with coronary heart disease; namely, to reduce the risk of these five cardiovascular events: nonfatal myocardial infarction, fatal and nonfatal stroke, angina, revascularization procedures, and hospitalization for heart failure.

* Recommended Dosage: Dosage range for hypercholesterolemia 10-80 mg/day, individualizing starting and maintenance doses.

* Special Considerations: In the Treating to New Targets (TNT) trial, which was the basis of this approval, people on 80 mg of Lipitor per day had more serious adverse events (2%) and discontinuations because of adverse events (10%) over 5 years, compared with those on the 10-mg dose (1% and 8%, respectively).

* Comment: In the TNT trial, the 80-mg daily dosage was associated with a significantly greater reduction in the risk of events that make up the five new indications, compared with the 10-mg dose. The trial compared the effect of the two dosages on cardiovascular events over a median of almost 5 years in 10,001 patients who had clinically evident heart disease and elevated LDL cholesterol levels, after an 8-week period during which all participants received 10 mg of Lipitor daily and achieved target LDL cholesterol levels lower than 130 mg/dL. About 80% were men, and nearly 40% were aged 65 years and older.

The primary end point was time to occurrence of any of these major cardiovascular events: death resulting from CHD, nonfatal MI, resuscitated cardiac arrest, and fatal and nonfatal stroke. There were 434 such events in those on 80 mg/day, versus 548 such events in those on 10 mg/day, a relative risk reduction of 22% a highly significant difference.

This overall reduction in risk was consistent, regardless of gender or whether patients were younger than age 65 or aged 65 years and older. As for individual events, the rate of nonfatal, non-procedure-related MI and fatal and nonfatal stroke was significantly reduced in the 80-mg/day group, when compared with placebo, but neither CHD death nor resuscitated cardiac arrest was significantly reduced, according to the revised package label for Lipitor.

Lipitor (80 mg/day) also significantly reduced some secondary end points: the rate of coronary revascularization, angina, and hospitalization for heart failure (but not the rate of peripheral vascular disease).

The rate of heart failure hospitalization was lower with Lipitor 80 mg/day, but only in the 8% of patients with a history of heart failure. All-cause mortality was not significantly different between the two groups, according to the drug's revised label.

Noting that atherosclerosis is not just a disease of the large coronary arteries, but involves the smaller vessels as well, Dr. Ann Bolger, professor of clinical medicine at the University of California, San Francisco, said that reducing the lipid burden and reducing inflammation with statins seem to decrease the incidence of cardiovascular events, which usually start at the endothelial level.

"Calming that whole process down and stopping its progression is an invaluable tool" offered by the statins, she said in an interview.

The effect that statins can have on heart failure hospitalization is particularly exciting, considering the epidemic of heart failure in the United States and other countries and the need for better tools to address this problem from different directions, added Dr. Bolger, also director of San Francisco General Hospital's echocardiography lab and chair of the American Heart Association's Council on Clinical Cardiology.

Because of the effects on both the large and small vessels, "it is not surprising that the very positive effects" of the statins would be manifest not only in events such as heart attack or stroke, but "also in terms of the progression down the path towards heart failure," she said. Dr. Bolger does not have any relationships with statin manufacturers.

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Title Annotation:NEW & APPROVED
Author:Mechcatie, Elizabeth
Publication:Internal Medicine News
Article Type:Drug overview
Date:May 1, 2007
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