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The Trouble With Heart Drug Studies

Posted on: Tuesday, 15 November 2005, 06:00 CST

By Steve Sternberg

DALLAS -- Two eagerly awaited studies of drugs that promised to fill critical gaps in the care of patients with heart failure and diabetes instead raised tough questions that doctors Monday struggled to answer.

One trial showed that the experimental drug levosimendan worked better than standard therapy in patients hospitalized with failing hearts. It also hinted, but did not prove, that the drug might increase patients' risk of dying within six months.

The second study tested the power of the drug fenofibrate to prevent heart attacks and other heart disease deaths in patients with diabetes. It failed. Yet those who took the drug appeared to be less likely to need angioplasty, bypass surgery or repairs of leaky blood vessels in the retina of the eyes.

Lead researcher Anthony Keech, of Australia's University of Sydney Medical School, told the American Heart Association here that the results suggest that fenofibrate, long available as TriCor, "could provide real protection" against the blood vessel damage that quadruples diabetics' heart disease risk.

The trouble is, most studies are designed to conclusively answer one question. Secondary results are tantalizing, but not proof. And although there were 49 deaths among patients getting levosimendan compared with 40 among those getting a placebo, the increase may result from chance. A second study to be released Wednesday will examine the drug's impact on survival.

"That's why medical research is so challenging," said Timothy Gardner of Christiana Care Health Services in Wilmington, Del., and chair of the AHA committee that evaluates research. "It requires lots of continual analysis."

The stakes are enormous. Abbott Labs, which makes levosimendan and markets fenofibrate for Fournier Pharma, saw its stock drop by more than 7% as a result of Monday's findings, closing at $40.35. Company spokeswoman Ilke Arici said the firm is giving the Food and Drug Administration the new results on levosimendan and has not made a decision about when to apply for U.S. approval. The drug is available abroad.

Levosimendan improves the heart's pumping power. The 600-patient study showed that the drug lifted patients' odds of regaining stability by a third and reduced the odds of getting worse by nearly as much. The side effects were headaches and low blood pressure.

Fenofibrate reduces blood levels of dangerous blood fats called triglycerides, a problem in type 2 diabetes. The 9,795-patient study failed to show significant difference in death rates between patients who got the drug and those who didn't. But the study found a 24% drop in non-fatal heart attacks. Mindful that this is a secondary finding, doctors said they'd rely on fenofibrate for patients with high triglycerides.

Raymond Gibbons of the Mayo Clinic in Rochester, Minn., said what people with diabetes need most is to lower their levels of bad cholesterol, or LDL.

(c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Source: USA TODAY

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