Three drugs that the US Food and Drug administration (FDA) says should not I be prescribed for diabetics who have heart failure may actually help many of those patients, a study suggests.
The study found that the one-year death rate for 2,226 patients prescribed the drugs Actos or Avandia was 13% lower than for patients who did not take either of the drugs. For patients prescribed both drugs, the one year death rate was 14% lower.
For those prescribed either Actos or Avandia plus Glucophage, the one-year death rate was 24% lower.
These drugs are prescribed to help control blood sugar levels in type 2 diabetics and work 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 who have advanced heart failure, in which the heart's ability to pump blood is greatly reduced. The agency requires a "black box" warning against prescribing Glucophage for patients who have heart failure that requires drug treatment.
Despite the government warning, many physicians still prescribe these drugs for high-risk patients, says study author Dr. Frederick A. Masoudi, a professor of medicine at the University of Colorado Health Sciences Center.
"We did an earlier study to show that despite the warnings, these drugs are used extensively in patients with heart failure and diabetes," Masoudi says. His study included more than 16,000 diabetes patients hospitalized for heart failure. The results showed fewer deaths in the following year for those patients taking one of the drugs than for people who weren't on one.
"There doesn't appear to be any initial harm from prescribing these drugs, and there may be significant benefits," Masoudi says. "Perhaps physicians feel that their benefits more than outweigh their side effects.
Further Study Needed
Masoudi, nevertheless, warns that his study results must be confirmed by carefully controlled trials before the warning against these drugs could be relaxed.
Dr. Robert Rizza, president of the American Diabetes Association, says that the study "cannot tell whether people who were less ill were placed on these drugs." A controlled trial would include information on the severity of illness in the participants, he adds. One such study is already under way. "It examines the use of these drugs in people with coronary artery disease, not heart failure, but it should yield useful information," he says.
Making the Decision
Until results from other studies are in, Masoudi says, 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," he advises. "The physician should carefully assess any issues involved in their use."
Rizza agrees. "You should consult with your physician regarding proper treatment for your diabetes," he says. "Your physician should discuss in detail the possible benefits and known risks associated with these drugs."