Novel drug shows promise for heart failure

Tuesday, November 15, 2005

DALLAS -- An experimental drug gave encouraging signs of being able to stabilize people with severe heart failure who come into emergency rooms gasping for breath, doctors reported Monday.

However, the novel drug from Abbott Laboratories, levosimendan, didn't produce the long-term benefits doctors had hoped to see for a problem that every year sends more than one million Americans to the hospital. Results of the study were reported at an American Heart Association meeting.

Heart failure occurs when weak hearts can't pump forcefully enough and fluid backs up into the lungs.

"They're all terribly sick. They come into the hospital severely short of breath, sweating, with varying blood pressures," said the chief researcher, Dr. Milton Packer of the University of Texas Southwestern Medical Center in Dallas.

The usual treatment is intravenous drugs to help them shed water, but that only works about half the time. Levosimendan works in a novel way to improve how strongly the heart contracts.

Doctors gave 300 emergency room patients in the United States, Israel and Australia the usual treatment and gave another 300 a one-day infusion of the experimental drug.

They measured improvement according to a composite scale of things like worsening shortness of breath, kidney function, and lung or circulatory problems.

Four days later, 26 percent of patients given usual care needed additional treatment because symptoms had worsened, but only 15 percent who received levosimendan did.

The chances of improving were 33 percent higher and the chances of worsening were 30 percent lower in those on the experimental drug.

However, six months later, those who got levosimendan were no better off than those given traditional drugs. In fact, more had died (49 versus 40) or developed heart rhythm problems, though the difference between the groups was considered small enough that it might have occurred by chance.

"There were some worrisome trends," said Dr. Timothy Gardner, a cardiologist at the Center for Heart and Vascular Health at Christiana Care Health Services in Wilmington, Del., who has no ties to the study or the drug's maker.

Still, he said the drug appeared to have unique benefits to bail out very sick patients over existing drugs.

Another study to be presented Wednesday will reveal whether the drug lowered death rates in very sick heart failure patients on continuous intravenous medications at home.

Monday's study was paid for by Abbott and Orion Pharma, a Finland-based firm that markets the drug in Europe as Simdax. Abbott is seeking approval in the United States.

Research on other heart disease treatments reported at the conference produced mixed results, including the largest test of whether improving cholesterol might help prevent cardiovascular problems in diabetics.

One study examined fenofibrate, a drug that lowers fats in the blood called triglycerides while raising levels of HDL or "good cholesterol" in people with Type 2 diabetes, the most common form. These people have three to four times the risk of heart disease as non-diabetics.

The 10,000 participants were not taking any cholesterol medicine when the study began; four out of five had no previous cardiovascular problems.

Roughly five years later, the combined rates of fatal heart problems and non-fatal heart attacks were roughly the same for those on the drug and those given dummy pills.

"There were many positive findings," including less nerve damage that leads to loss of vision, amputations and kidney damage, said lead researcher Dr. Anthony Keech of the University of Sydney in Australia.

"I don't think these results would support choosing fenofibrate over a statin," a widely used type of cholesterol-lowering medication, but lots of reason to add it, he said.

However, government regulators have warned of problems, including a higher risk of a rare muscle problem, when statins are combined with fibrate drugs.

"I wouldn't (use it) based on the results of this trial," Gardner said.


On the Net:

Conference: www.americanheart.org

Fish recommendations: http://www.americanheart.org/presenter.jhtml?identifier4632

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