March 30, 2009 / 7:46 PM / 10 years ago

UPDATE 1-Crestor fails to cut heart risks in dialysis study

* 2nd statin study to show no such benefit in dialysis

* 2,776-patient study used 10 mg of Crestor

(Adds comments about other renal study)

By Lewis Krauskopf

ORLANDO, Fla., March 30 (Reuters) - AstraZeneca Plc’s (AZN.L) cholesterol-lowering drug Crestor failed to significantly reduce heart problems and death among dialysis patients, researchers said on Monday.

The results of the Aurora study dampened hopes for reducing heart risks in patients with serious renal disease, who are vulnerable to cardiovascular problems.

Statin cholesterol-lowering drugs such as Crestor have been proven to cut cardiovascular risk in many populations, but the Aurora trial was the second in which the category failed to show heart benefits in dialysis patients.

“Our data show that starting statin treatment in maintenance dialysis patients does not seem to benefit patients by preventing CV events,” said Dr. Bengt Fellstrom of University Hospital in Uppsala, Sweden, who presented the results at the American College of Cardiology scientific meeting in Orlando.

The 2,776-patient study failed to reach the primary goal of reducing combined heart attacks, strokes and cardiovascular death. On a random basis, patients received either 10 milligrams of Crestor, also known as rosuvastatin, or a placebo.

The patients had end-stage renal disease and were undergoing hemodialysis, but were not on a statin before the trial.

Subjects on Crestor had 396 events, compared with 408 among those taking a placebo, but the difference was not statistically significant. There was no difference among individual categories, either.

Crestor, the most potent statin, did lower levels of bad LDL cholesterol by 43 percent.

Cutting mortality from cardiovascular disease in dialysis patients is a global public health challenge, according to an editorial in the New England Journal of Medicine that accompanied publication of the Aurora results.

A 1,250-patient trial of Pfizer Inc’s (PFE.N) Lipitor statin in 2005 also failed to show cardiovascular benefit in dialysis patients, leading some to suspect a negative outcome for Aurora.

“The past 10 years have seen trials of many interventions designed to improve survival and cardiovascular outcomes in these patients,” the editorial said. “It appears that statins have now joined this group of ‘promising but ineffective’ interventions.”

The editorial said about 75 percent of U.S. deaths from heart causes in dialysis patients stemmed from problems that statins are not approved to address, such as death due to arrhythmia.

Earlier this month, Sanford Bernstein analyst Tim Anderson published a research note saying the Aurora trial may have failed to reach its main goal. But Anderson said such a result would not be a major setback for Crestor’s commercial prospects because dialysis patients are not a core group of statin users.

Vytorin, another cholesterol-lowering drug sold by Merck & Co Inc (MRK.N) and Schering-Plough Corp SGP.N, is also being studied in renal disease patients in a 9,000-patient study known as Sharp. Vytorin combines a statin with Zetia, another type of cholesterol fighter.

The New England Journal editorial said “one would expect” data and safety monitors of the Sharp trial would review Aurora in detail in determining whether to continue the trial.

But Fellstrom, Aurora’s lead investigator, told a news conference he thinks the study should continue because it also involves patients who have not undergone dialysis yet.

AstraZeneca’s stock closed up 3.4 percent in London. (Editing by Lisa Von Ahn and Gerald E. McCormick)

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