Diabetes Drug May Up Elderly Deaths
Study Shows Higher Rate of Death, Heart Attack, and Congestive Heart Failure in Older Diabetes Patients Taking Avandia
Dec. 11, 2007 -- A new Canadian study links the diabetes drug Avandia to higher rates of
attack, and congestive heart
failure in diabetes patients aged 66 and older.
The researchers say their study is the first to document a higher death rate
among patients taking thiazolidinediones -- a class of diabetes drugsthat
includes Avandia, Actos, Avandaryl, Avandamet, and Duetact -- and that risk in
their study was limited to Avandia's active ingredient,
Rosiglitazone is also an
ingredient in Avandaryl and Avandamet.
But Avandia's maker says the study has "significant limitations and
generates misleading conclusions" about heart attack and death.
The study appears in tomorrow's edition of The Journal of the American
Diabetes Drug Study
The new study included some 159,000 diabetes patients aged 66 and older in
All of those patients took at least one oral diabetes drug between 2002 and
Using several databases, the researchers tracked death, congestive heart
failure, and heart attack over about four years among patients taking
thiazolidinediones or other types of diabetes drugs.
During that time, nearly 12,500 patients (about 8%) were hospitalized for
congestive heart failure, a similar number had a heart attack, and more than
30,000 (19%) died of any cause.
Patients taking thiazolidinediones were 29% more likely to die, 40% more
likely to have a heart attack, and 60% more likely to develop congestive heart
failure than patients taking different types of diabetes drugs, according to
That pattern "appeared limited to rosiglitazone" and didn't include
pioglitazone, the active ingredient in Actos and Duetact, write the
researchers, who included Lorraine Lipscombe, MD, MSc, of the Institute for
Clinical Evaluative Sciences in Toronto.
Relatively few patients were taking Actos, so Lipscombe's team calls for
further studies to see if the increased risks are limited to rosiglitazone.
"As you can see in our paper, the risk appeared limited to
rosiglitazone, but there were far fewer numbers on pioglitazone so we can't
exclude a similar risk with that drug as well," Lipscombe tells
WebMD via email.
The study doesn't prove that Avandia caused any deaths, heart attacks, or
cases of congestive heart failure.
Diabetes Drug Warnings
In November, the FDA ruled that
Avandia must carry a "black box" warning (the FDA's sternest
warning) about the risk of heart attack and angina.
In August, the FDA announced that
all thiazolidinediones will get a black box warning about the risk of
congestive heart failure in certain patients.
Drug Companies Respond
WebMD contacted GlaxoSmithKline, the drug company that makes Avandia, Avandaryl, and Avandamet,
and Takeda Pharmaceuticals, which makes Actos and Duetact, for
their comments on the study.
GlaxoSmithKline provided a written statement that argues that the Canadian
study's conclusions about the risk of heart attack and death "are
inconsistent with a more robust body of evidence from large, long-term,
prospective, well-designed clinical studies."
"The inconsistency could be due to the fact that the Avandia patients
were older, sicker, and had more chronic diseases -- and therefore higher
baseline risk for [cardiovascular] events -- than patients in other medicine
groups," GlaxoSmithKline spokeswoman Nancy Pekarek tells WebMD via
Robert Spanheimer, MD, senior
director of diabetes for Takeda, tells WebMD that "we're pleased that
this paper contains important information about Actos and we're pleased that
data is consistent with our body of evidence showing no increase in heart
attack or death with Actos."
Spanheimer says that while fewer
patients in the study were taking Actos, the study's findings are consistent
with "both the direction and the degree of change that we have seen in
previous studies of Actos."