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3 Risky Diabetes Drugs May Be Safe for Heart Patients

Study finds drugs that FDA says should not be given actually may help diabetics.

MONDAY, Feb. 7, 2005 (HealthDay News) -- Three drugs that the U.S. Food and Drug Administration says should not be prescribed for diabetics who have heart failure may actually help many of those patients, a new study suggests.

The drugs are Actos and Avandia, both classified as thiazolidinediones, and Glucophage, a member of a different chemical family. All are prescribed to help control blood sugar levels in persons with type 2 diabetes, the kind that typically strikes in adulthood. They act by making the body more sensitive to insulin, the hormone that helps cells use blood sugar for energy.

The FDA cautions against using Actos and Avandia in people with advanced heart failure, in which the heart's ability to pump blood is greatly reduced. And the agency requires a "black box" warning against prescribing Glucophage for patients with heart failure that requires drug treatment.

Nevertheless, many physicians prescribe these drugs for these high-risk patients, said study author Dr. Frederick A. Masoudi, a professor of medicine at the University of Colorado Health Sciences Center. And his study of more than 16,000 diabetes patients hospitalized for heart failure found a lower death rate over the following year for those who got one or another of the drugs than for those who didn't.

The findings appear in the Feb. 8 issue of Circulation.

"We did an earlier study to show that despite the warnings, these drugs are used extensively in patients with heart failure and diabetes," Masoudi said. "Perhaps physicians feel that their benefits more than outweigh their side effects."

The new study found that the one-year death rate for 2,226 patients prescribed either Actos or Avandia was 13 percent lower than for patients who did not take either of the drugs. For patients prescribed both drugs, the one-year death rate was 14 percent lower. And for those prescribed either Actos or Avandia plus Glucophage, the one-year death rate was 24 percent lower.

"There doesn't appear to be any initial harm from prescribing these drugs, and there may be significant benefits," Masoudi said.

But the study results must be confirmed by carefully controlled trials before the warning against these drugs could be relaxed, Masoudi said. He said he and his colleagues have had "some initial conversations about conducting such studies" with the companies that market the drugs, but it will take years for such trials to be planned and implemented.

Meanwhile, he said, the decision about using the drugs must be made on a case-by-case basis.

"The physician and the patient should discuss their use thoroughly," Masoudi said. "The physician should carefully assess any issues involved in their use."

That's the correct approach, said Dr. Robert Rizza, president-elect of the American Diabetes Association.

"You should consult with your physician regarding proper treatment for your diabetes," he said. "Your physician should discuss in detail the possible benefits and known risks associated with these drugs."

Controlled trials with people who have diabetes and heart failure are needed because the kind of study reported by Masoudi and his colleagues "cannot tell whether people who were less ill were placed on these drugs," Rizza said. A controlled trial would include information on the severity of illness in the participants, he said.

One such study already is under way, Rizza said. "It examines the use of these drugs in people with coronary artery disease, not heart failure, but it should yield useful information," he said.

More information

Almost anything you need to know about diabetes is available from the American Diabetes Association.

SOURCES: Frederick A. Masoudi, M.D., professor, medicine, University of Colorado Health Sciences Center, Denver; Robert Rizza, M.D., professor, medicine, Mayo Clinic, Rochester, Minn.; Feb. 8, 2005, Circulation
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