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Senior Citizen Health & Medicine
Drug Reduces Type 2 Diabetes Risk 62 Percent for
Those at Highest Risk
41 million Americans at high risk with
'pre-diabetes' condition
September 18, 2006 - Giving people at high-risk of
developing type 2 diabetes the drug rosiglitazone (Avandia), along with
recommended lifestyle changes, can reduce the risk of developing the
disease for those at the highest risk by more than 60 percent, according
to the largest diabetes-prevention trial to date.
A study last May found that 22 percent of senior citizens age 65 and
older have diabetes and nearly 40 percent suffer with a form of
pre-diabetes called impaired fasting glucose.
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Health & Medicine |
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The drug rosiglitazone maleate reduced the risk of
developing type 2 diabetes by 62 percent relative to placebo for
individuals determined to have "pre-diabetes."
This 62 percent reduction was highly statistically
significant and additive to standard counseling on healthy eating and
exercise, which was provided to all participants in the trial. The
results of the landmark study were reported this weekend both in The
Lancet and at the 42nd annual meeting of the European Association for
the Study of Diabetes (EASD).
The results of both the HOPE and DREAM studies
offer us new strategies for preventing and delaying the onset of
diabetes and its devastating complications said Dr. Diane Finegood,
based in Vancouver, and the Scientific Director of the Canadian
Institutes of Health Researchs Institute of Nutrition, Metabolism and
Diabetes.
The Canadian Institutes of Health Research (CIHR)
is the Government of Canada's agency for health research, which helped
fund the study.
The DREAM (Diabetes REduction Assessment with
ramipril and rosiglitazone Medication) trial evaluated the likelihood of
progression to type 2 diabetes over a three-year median follow-up period
among 5,269 participants with the condition known as pre-diabetes.
In pre-diabetes, blood sugar levels are higher than
normal but not yet high enough for a diagnosis of type 2 diabetes.
Participants included in the study were randomized to rosiglitazone (8
mg daily) or placebo and to ramipril (15 mg daily) or placebo and were
assessed every six months for three to five years to determine if
rosiglitazone or ramipril can reduce the risk of developing type 2
diabetes in individuals with pre-diabetes, when added to healthy eating
and exercise counseling.
The DREAM study was not designed as a direct
comparison between rosiglitazone and ramipril. Results from the ramipril
arm of the study, which increased regression to normoglycemia but did
not reduce the risk of diabetes or death, are also being reported at
EASD and published separately in New England Journal of Medicine.
In this study, designed and conducted by the
Population Health Research Institute at McMaster University, Canada,
10.6% of participants receiving rosiglitazone progressed to type 2
diabetes versus 25% of participants treated with placebo. In the
composite primary endpoint of development of diabetes or death from any
cause, rosiglitazone demonstrated a 60 percent risk reduction relative
to placebo.
"The DREAM findings are particularly significant as
we are in the midst of an epidemic of type 2 diabetes with global
implications. It is also noteworthy that the damaging complications of
type 2 diabetes can often precede the diagnosis of this condition by
several years," said Dr. Bernard Zinman, DREAM Steering Committee
Member, director of the Diabetes Centre, Mount Sinai Hospital and
professor of medicine, University of Toronto, Canada.
"By demonstrating that rosiglitazone significantly
reduced the risk of developing type 2 diabetes, these data provide
important evidence that it may be possible to alter the course of rising
blood sugar levels and its consequences."
Over the three-year median follow-up period of the
trial, 51 percent of the participants receiving rosiglitazone returned
to normal blood sugar levels compared to 30 percent of participants
receiving placebo.
Thus, participants taking rosiglitazone were 70
percent more likely than those taking placebo to return to normal blood
sugar levels. As might be expected, participants in the placebo group
with higher Body Mass Index (BMI), an indicator of obesity, were more
likely than those with lower BMI to progress to type 2 diabetes.
However, the risk of developing diabetes did not
increase with BMI in the group randomized to rosiglitazone. These
findings suggest that rosiglitazone may reduce the risk of developing
diabetes that is attributable to obesity.
"GSK is committed to groundbreaking research for
the treatment of pre- diabetes and type 2 diabetes in order to improve
patient outcomes. We believe the long-awaited findings from the DREAM
trial will lead to a better understanding of type 2 diabetes and its
treatment," said Dr. Lawson Macartney, senior vice president,
Cardiovascular and Metabolic Medicine Development Centre,
GlaxoSmtihKline.
"The DREAM trial is the largest diabetes
prevention trial conducted to date and provides the first body of
evidence that rosiglitazone can reduce the risk of progression from
pre-diabetes to type 2 diabetes in high-risk patients."
Currently there are no medications indicated for
the treatment of pre-diabetes. Rosiglitazone is an approved treatment
for type 2 diabetes that improves blood sugar control. It is an insulin
sensitizer and works differently than other classes of type 2 diabetes
medications by directly targeting a key underlying cause of the disease:
insulin resistance.
In the study, rosiglitazone was generally well
tolerated.
While not everyone with pre-diabetes develops type
2 diabetes, other large clinical outcomes trials have demonstrated that,
without intervention, between 29 to 55 percent of individuals with
pre-diabetes develop type 2 diabetes over the course of three years. As
type 2 diabetes progresses, the combined effects of insulin resistance
and beta-cell dysfunction can make it increasingly difficult for
physicians to help patients control blood sugar levels.
About the DREAM Study
DREAM is an international, multi-center,
randomized, double-blind, 2x2 factorial trial involving 5,269
participants from 21 countries with impaired glucose tolerance (IGT)
and/or impaired fasting glucose (IFG), also known as pre-diabetes, who
are therefore a high risk of developing type 2 diabetes. The DREAM study
was conducted by Population Health Research Institute at the Michael G.
DeGroote School of Medicine at McMaster University and Hamilton Health
Sciences in Hamilton Ontario. DREAM was funded by a peer-reviewed grant
from the Canadian Institutes of Health Research (CIHR) via the CIHR/Rx&D
Collaborative Research Program as well as by GlaxoSmithKline,
sanofi-aventis and King Pharmaceuticals.
About Insulin Resistance, Pre-diabetes and Type
2 Diabetes
Insulin resistance occurs when the body does not
respond properly to its own natural insulin. Insulin is a hormone in the
body that helps convert blood sugar to energy so it can be used by the
body's cells. In individuals with insulin resistance, the pancreas tries
to keep up with the demand for insulin by producing and releasing more.
Eventually, the pancreas cannot keep up with the body's need for
insulin, and excess sugar builds up in the bloodstream.
Insulin resistance contributes to the progression
from normal blood sugar levels to pre-diabetes to type 2 diabetes. When
blood sugar levels are higher than normal, but not yet high enough to be
diagnosed as diabetes, the condition is referred to as pre-diabetes.
Pre-diabetes is a precursor to type 2 diabetes, however, not everyone
with pre-diabetes goes on to develop the disease. Type 2 diabetes occurs
either when the body does not produce enough insulin or does not respond
properly to its own natural insulin.
In type 2 diabetes, when sugar builds up in the
blood instead of going into the cells, it can starve the cells of
energy, and over time, high blood sugar levels can cause
diabetes-related complications, such as stroke, heart disease, kidney
disease, blindness and amputation.
In the United States, 41 million people have
pre-diabetes and more than 18 million have type 2 diabetes.
Notes:
GlaxoSmithKline company information, visit
http://www.gsk.com/.
The Canadian Institutes of Health Research (CIHR)
is the Government of Canada's agency for health research. CIHR's mission
is to create new scientific knowledge and to catalyze its translation
into improved health, more effective health services and products, and a
strengthened Canadian health care system. Composed of 13 Institutes,
CIHR provides leadership and support to over 10,000 health researchers
and trainees across Canada.
http://www.cihr-irsc.gc.ca/
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