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Use of Diabetes
Medication by Older Adults associated with
increased risk of serious heart problems,
death
Newswise — Older
patients treated with the diabetes
medications known as thiazolidinediones
(which include rosiglitazone) had a
significantly increased risk of heart
attack, congestive heart failure and death,
compared with the use of other hypoglycemic
drugs, according to a study in the December
12 issue of JAMA. The authors suggest that
these results provide further evidence that
this class of medication may cause more harm
than good.
The thiazolidinediones
(TZDs) rosiglitazone and pioglitazone are
oral hypoglycemic agents used to treat type
2 diabetes and have been shown to improve
glycemic control. “While improved glycemic
control has been linked to better clinical
outcomes in diabetes and TZDs have been
suggested as having potential cardiovascular
benefits, recent concerns have arisen
regarding adverse cardiac effects of these
drugs,” the authors write.
Some research has
indicated that both rosiglitazone and
pioglitazone may increase the risk of
congestive heart failure (CHF), and that
rosiglitazone may be associated with an
increased risk of acute myocardial
infarction (AMI; heart attack) and death.
“These findings prompted a recent hearing by
a U.S. Food and Drug Administration advisory
panel regarding the safety of rosiglitazone;
however the panel voted against removing
rosiglitazone from the market because of
insufficient data.”
Lorraine L. Lipscombe,
M.D., M.Sc., of the Institute for Clinical
Evaluative Sciences, Toronto, and colleagues
evaluated the risks of CHF, heart attack,
and all-cause death associated with the use
of TZDs, compared with other oral
hypoglycemic agents among patients age 66
years or older with diabetes.
This older
patient population has often been
under-represented in trials of TZDs, even
though they have a high prevalence of
diabetes, and may be at greater risk of
medication-related harms.
The researchers
analyzed data from health care databases in
Ontario that included 159,026 individuals
with diabetes who were treated with oral
hypoglycemic agents and were followed for a
median (midpoint) of 3.8 years, through
March 2006. During this time, 7.9 percent of
patients had a hospital visit for congestive
heart failure (n = 12,491), 7.9 percent had
a hospital visit for a heart attack (n =
12,578), and 19 percent died (n = 30,265).
Compared to oral
hypoglycemic agent combination therapy
users, current users of TZD monotherapy had
a 60 percent increased risk of congestive
heart failure; had a 40 percent increased
risk of heart attack; and had a 29 percent
increased risk of death. These increased
risks associated with TZD use appeared
limited to rosiglitazone.
“Our findings argue
against current labeling of TZDs that warns
against use only in persons at high risk of
CHF, as we did not identify any subgroup of
older diabetes patients who may be protected
from adverse effects of TZDs,” the authors
write. “These findings provide evidence from
a real-world setting and support data from
clinical trials that the harms of TZDs may
outweigh their benefits, even in patients
without obvious baseline cardiovascular
disease.”
“Further studies are
needed to better quantify the risk-benefit
tradeoffs associated with TZD therapy and to
explore whether the hazards associated with
these agents are specific to rosiglitazone.
In the interim, treatment decisions must
remain individualized, with clinicians
weighing the potential benefits and harms of
TZD treatment, especially among high-risk
elderly populations.”
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