Also This Month: Lessons Learned from the Avandia Controversy
ALEXANDRIA, Va., Nov. 27 /PRNewswire-USNewswire/ -- Depressed, older adults with diabetes live longer when they are treated for depression, according to a study in the December issue of Diabetes Care, which publishes on November 27, 2007.
Also being published this month is an editorial by U.S. Food and Drug Administration (FDA) Medical Officer Dr. Robert Misbin, highlighting lessons learned from the recent Avandia controversy and suggesting a re-evaluation of the approval process for diabetes drugs.
The depression study, which followed primary care patients in the New York City, Philadelphia and Pittsburgh areas for five years, also showed that treating depression reduced mortality more for those who had diabetes than for those who did not.
"Depression is not only common in persons with diabetes but contributes to not taking medicines, not following prescribed diets, and overall reduced quality of life," said lead researcher Dr. Hillary R. Bogner, Assistant Professor at the Department of Family Practice and Community Medicine at the University of Pennsylvania.
Depression and diabetes are two of the most commonly treated health problems treated in primary care settings. Previous studies have drawn a link between diabetes and depression, and between the combination of the two an increased risk of premature death. This is the first known study to examine the relationship between diabetes and mortality in a depression intervention trial.
The results led researchers to conclude that better models of care should be developed that integrate depression management into the treatment of people with diabetes.
Depressed people with diabetes who received more resources for depression treatment were half as likely to die over a 5-year period compared to depressed people with diabetes who did not receive more resources for depression treatment.
Lessons from the Avandia Controversy
"The time has come to reassess what should be expected of a new drug to treat diabetes," concludes an editorial written by Dr. Robert Misbin, a Medical Officer for the U.S. Food and Drug Administration (FDA).
The editorial suggests that the FDA "reevaluate criteria for approval of drugs to treat type 2 diabetes," in light of the recent controversy surrounding the diabetes drug rosiglitazone (Avandia).
Rosiglitazone, approved by the FDA in 1999, came under fire earlier this year when a meta-analysis in the New England Journal of Medicine reported that it may increase the risk of heart attacks. An FDA advisory committee concluded that the evidence against the drug's safety was insufficient to have it withdrawn from the market. But the episode "undermined the confidence that patients have in the drugs they take and in the physicians who prescribe those drugs," Misbin wrote. "It cast further doubt on FDA's ability to protect patients from harm."
Misbin concluded that it "is no longer enough" to show that a new drug is more effective than placebo in lowering glucose levels. "New drugs should be tested in comparison to other antidiabetic agents that are already in use," he wrote. "A plan should be in place at the time of approval that will determine what benefits and harm can be expected from chronic use."
Diabetes Care, published by the American Diabetes Association, is the leading peer-reviewed journal of clinical research into the nation's fifth leading cause of death by disease. Diabetes also is a leading cause of heart disease and stroke, as well as the leading cause of adult blindness, kidney failure, and non-traumatic amputations. For more information about diabetes, visit the American Diabetes Association Web site http://www.diabetes.org or call 1-800-DIABETES (1-800-342-2383).
|SOURCE American Diabetes Association|
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