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Senior Citizen Health & Medicine
Older Depressed Diabetics Live Longer if Depression
is Treated: Diabetes Care
FDA medical officer looks at Avandia controversy in
magazine editorial
Dec. 2, 2007 – Older diabetics that also suffer
with depression live longer if the depression is treated, according to a
study in the December issue of Diabetes Care. The magazine also
carries an editorial written by FDA Medical Officer Dr. Robert Misbin
that highlights "lessons learned" from the recent Avandia controversy.
Misbin suggests a re-evaluation of the approval
process for diabetes drugs (read more below).
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 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.
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Depression Associated With Increased Risk of
Heart Disease and Heart Failure -
6/27/06
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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.”
Editor's Notes
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).
American Diabetes Association (ADA)
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