A Food and Drug Administration advisory panel recommended today that drug-maker AstraZeneca be allowed to expand the labeling on its cholesterol-lowering drug Crestor to include some people who do not have high cholesterol levels. That could allow as many as 6 million more people to use the drug, preventing about 50,000 heart attacks, strokes and deaths each year, experts said.
The FDA is not required to follow the recommendations of its advisory panels, but it usually does.
Crestor, known generically as rosuvastatin, is one of a family of drugs called statins that block production of cholesterol in the liver. More than 13 million Americans take statins regularly and worldwide sales total more than $33 billion per year, most of that in the United States.
But many studies have shown that statins have a variety of other effects, including protection against glaucoma, cataracts, macular degeneration, and perhaps even flu. They also reduce inflammation, which plays a key role in heart disease. The inflammation specifically linked to cardiovascular problems is characterized by a rise in levels of C-reactive protein, or CRP. Crestor, and perhaps other statins as well, apparently reduce the risk of heart attacks by reducing levels of CRP in addition to reducing cholesterol.
In a study of nearly 18,000 people with high levels of CRP but normal or slightly elevated levels of cholesterol, researchers found that Crestor reduced the risk of death from heart disease by 20%. Overall, there was a 44% reduction in deaths, strokes, heart attacks and hospitalizations to clear clogged arteries. The planned four-year study was terminated after only two years because the results were so dramatic. That study was the primary basis for AstraZeneca's application to expand the labeling for Crestor.
That study showed some potential side effects of the drug. About 2.8% of patients taking the drug developed diabetes, compared with 2.3% of those taking a placebo. But all drugs in the class do this, and experts think the drugs may simply make latent diabetes appear earlier. There were also 13 deaths due to gastrointestinal disorders among those taking Crestor, compared with only one in the placebo group. Experts think this is probably due to chance, but recommended that monitoring continue.
Sales of Crestor totaled $3.6 billion last year, and experts predicted that FDA approval of the labeling change could add an extra $500 million. Crestor is one of the most expensive statins, costing about $3.45 per day. Simvastatin (Zocor) is now sold in a generic form and the bestselling statin, Pfizer's Lipitor, will be available as a generic in 2011.
AstraZeneca estimates that about half of the patients who suffer a heart attack do not have high cholesterol levels. Heart disease kills about 450,000 people in the United States each year. An estimated 935,000 Americans have heart attacks each year and 795,000 have strokes.
-- Thomas H. Maugh II