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AstraZeneca's Crestor fails in heart-failure study

LONDON/NEW YORK (Reuters) - Heart-failure patients given AstraZeneca Plc’s Crestor and standard drugs are just as likely to have heart attacks and strokes or die of cardiovascular problems as those on standard therapy alone, researchers said on Monday.

The news is a blow for Britain’s second-biggest drug company, which had hoped to establish Crestor as the first cholesterol-lowering statin to show clear benefits in treating elderly patients with the chronic heart condition.

A successful result could have added $1 billion to U.S. revenues alone, according to industry analysts. But many had thought proving the drug’s benefits would be tough. Crestor sold $2 billion worldwide in the first nine months of 2007.

“This might stay my hand,” in giving heart-failure patients a statin if they have no other need for it, said Gordon Tomaselli, a professor of medicine at Johns Hopkins Medicine, who moderated a briefing on the study.

Results of a 5,000-patient study showed Crestor was no better than a placebo, although it did cut levels of “bad” LDL cholesterol and C-reactive protein -- an inflammatory marker -- and reduced hospitalizations for cardiovascular causes.

Why these benefits did not translate into better outcomes is not clear but could be due to the nature of heart failure, John Kjekshus of the University of Oslo and colleagues told the annual meeting of the American Heart Association (AHA) in Orlando, Florida.

“Our findings suggest the major cause of death in these patients was likely not to be related to atherosclerotic events, where benefit with statins in non-heart failure patients has been demonstrated, but instead may have been caused by the deterioration of failing heart muscle damaged beyond repair,” he said in a statement.

AstraZeneca, whose shares fell about 1 percent, said the study had been “novel and challenging” and, though unsuccessful, had established Crestor’s safety in heart-failure patients.

Ray Gibbons, a cardiologist at the Mayo Clinic and past president of the AHA, said heart-failure patients are on enough medications and keeping them compliant with current proven drugs, such as drugs called beta-blockers, is tough enough.

The study shows “it is far more important that heart-failure patients get a beta-blocker than a statin,” he said.

Heart failure is a hard-to-treat condition in which the weakened heart cannot pump enough blood to meet the body’s need for oxygen, causing shortage of breath and other problems. It is a leading cause of hospitalization among the elderly.


Frederick Masoudi of the Denver Health Medical Center said in an online commentary in the New England Journal of Medicine that several uncertainties meant doctors should not change medical practice for now.

“Although the results suggest there was no benefit on the primary outcome ... the study ends up raising almost more questions than it answers,” he said in a phone interview. “One should not rush to take (heart-failure) patients like these off statins.”

Although Crestor’s cholesterol-lowering ability has long been documented, the so-called CORONA study was the first to test whether the 4-year-old drug, which is known generically as rosuvastatin, actually improved patient outcomes.

All patients were given a number of drugs considered optimal therapy for heart failure -- including diuretics, beta-blockers and blood-pressure medicines. In addition, some were also given a daily dose of 10 milligrams of Crestor.

After 33 months of treatment, 692 patients in the Crestor group had heart attacks, strokes or died of cardiovascular complications, against 732 of those who took standard treatments alone. The difference was not statistically significant.

One positive finding was that patients on Crestor did have fewer hospitalizations and heart-failure-related hospitalizations, researchers said.

Rival statins, including Pfizer Inc’s Lipitor and Merck & Co’s Zocor, have previously shown an ability to reduce the risk of strokes and heart attacks in other population groups by up to 30 percent.

But no statin has before been tested to assess its ability to protect heart-failure patients from such long-term health consequences, AstraZeneca officials said. In fact, trials of statins have traditionally excluded heart-failure patients.

Heart failure develops in an estimated 1 percent of the population, most commonly among the elderly.

Additional reporting by Kim Dixon in Orlando