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Crestor Cut Heart Risk in People With Low Cholesterol

AstraZeneca Plc’s Crestor slashed the risk of heart attack, stroke and death by nearly half in people with normal or low cholesterol in a study, potentially opening a way to save the lives of thousands of seemingly healthy people.

The benefits were shown in patients with high levels of a protein called CRP, an indicator of inflammation. CRP is tied to heart risk even in people with no additional symptoms. Crestor is approved by U.S. regulators only to lower bad cholesterol.

The trial, reported at the American Heart Association meeting in New Orleans, may help double Crestor’s yearly sales to $6.33 billion by 2015, expand the $34 billion market for all cholesterol-lowering medicine and prevent 50,000 heart complications a year, analysts and doctors said. The results suggest an additional 6 million men over age 50 and woman over age 60, the group studied, should take the drugs, doctors said.

“Half of heart attacks and strokes happen among apparently healthy men and women with normal or even low levels of cholesterol,” said Paul Ridker, the lead investigator from Harvard Medical School in Boston. “We as physicians simply cannot assume our patients are at low risk just because they have low cholesterol.”

AstraZeneca, the U.K.’s second-largest drugmaker, soared 43 percent in London trading amid anticipation of the results since the study was halted at the end of March. The London-based drugmaker fell 90 pence, or 3.5 percent, to close at 2,684 pence in trading on Nov. 7. Steven Scala, an analyst at Cowen & Co. in Boston, said in an Oct. 29 note that Crestor sales, an estimated $3.45 billion in 2008, may almost double on the CRP indication.

Marketing Application

AstraZeneca, which funded the study, said it plans to submit the findings to regulators in the first half of 2009 for approval to expand its marketing in the U.S.

The study may also spur a push to screen healthy people for CRP, though doctors at the meeting debated whether the findings resulted from CRP control or lowering bad cholesterol further than is now recommended.

“The findings presented today cannot determine whether lowering cholesterol, reducing inflammation, or a combination of both is responsible for the effects seen in the paper,” said Timothy Gardner, president of the American Heart Association, in a statement from the organization.

Bad cholesterol fell by half among trial subjects on Crestor, and there was a 37 percent reduction in CRP levels. Many patients in the study had heart risks beyond CRP levels, including high blood pressure, smoking, a family history and metabolic syndrome. They may have simply responded to aggressive treatment, Gardner said.

Guidelines Panel

Elizabeth Nabel, head of the National Heart Lung and Blood Institute, said she has asked an expert panel to review the results of the trial and two others that show routine tests for CRP, or C-reactive protein, can help predict heart attacks and strokes in the middle-aged and older Americans.

The panel will craft guidelines for how and when the test should be used, she said in a statement.

In the Crestor study, dubbed Jupiter, patients on the drug were 47 percent less likely to have a heart attack, stroke or die of cardiac causes after two years than those using a placebo. As many as 32 million people who don’t currently qualify for cholesterol-lowering therapy have elevated CRP levels, the company said.

Crestor belongs to a family of drugs called statins that includes Pfizer Inc.’s top-selling Lipitor. Past studies show these drugs cut heart attacks, strokes and death by 25 percent.

`Home Run’

While the Crestor trial didn’t say whether other statins offer similar benefits, Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio, referred to the findings as an “out- of-the park home run” that will change medical practice.

“This may be the most important trial we’ve seen in a decade,” Nissen said in a telephone interview.

Heart disease, the leading cause of death worldwide, kills 450,000 Americans each year. Another 920,000 have a heart attack and 780,000 suffer strokes annually.

The 17,802-patient study is the largest ever conducted on Crestor and should also serve to resolve lingering questions about the drugs safety in patients with high cholesterol.

Just 19 patients in the study developed myopathy, a muscle weakness linked to statins, with a near even split between those getting Crestor and those on placebo. In addition, there weren’t more new cancers among Crestor users, though there were more cases of physician-reported diabetes.

Long-Term Safety

Still, long-term use in the general population hasn’t been studied, and it is important to extend the tests to other statins, including generic versions that cost much less, said Mark Hlatky, from Stanford University School of Medicine in California, in an editorial released today by the New England Journal of Medicine.

“Long-term safety is clearly important in considering committing low-risk subjects without clinical disease to 20 years or more of drug treatment,” Hlatky wrote. “Finally, the cost of rosuvastatin, roughly $3.45 per day, is much higher than that of generic statins.”

Thomas Wang, an assistant professor at Harvard Medical School who has studied CRP testing, said it is unclear whether a universal test can give the consistent results needed to put patients on a cholesterol drug for the rest of their lives.

`Day-to-Day Changes’

“Day to day, your levels of CRP may change and it may change substantially,” said Wang in a telephone interview before the results were reported. “Once you put the person on the drug, you’re likely to have them on it indefinitely.”

Overall, the study found 83 heart attacks, strokes and deaths from cardiac causes among the 8,901 patients given Crestor, or 0.9 percent, compared with 157 in the 8,901 patients, 1.8 percent, getting a placebo. That means 120 people would need to be treated for 1.9 years to prevent just one event, Hlatky wrote in his editorial.

The results, though, doubled what the researchers anticipated and stretched across every group analyzed, including women. The findings may lay to rest questions about the effect of cholesterol drugs in women and minorities, who were excluded from earlier studies. They reaped even more protection than men in the Crestor trial, researchers said.

“Jupiter should dramatically change prevention guidelines,” said James Willerson, director of the Texas Heart Institute in Houston. “This is an approach we can start using tomorrow.”

November 9, 2008 - Posted by | News | ,

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