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Senior Citizen Health & Medicine
Surprising Number of Deaths Cause NIH Institute to
Shut Down Diabetes Trial
For safety, NHLBI changes intensive blood sugar
treatment strategy in trial of diabetes and cardiovascular disease
 Feb. 6, 2008 - The National Heart, Lung, and Blood
Institute (NHLBI) of the National Institutes of Health has stopped one
treatment within a large, ongoing North American clinical trial of
diabetes and cardiovascular disease 18 months early due to safety
concerns after review of available data, although the study will
continue.
In this trial of adults with type 2 diabetes at
especially high risk for heart attack and stroke, the medical strategy
to intensively lower blood glucose (sugar) below current recommendations
increased the risk of death compared with a less-intensive standard
treatment strategy. Study participants receiving intensive blood glucose
lowering treatment will now receive the less-intensive standard
treatment.
The ACCORD (Action to Control Cardiovascular Risk
in Diabetes) study enrolled 10,251 participants. Of these, 257 in the
intensive treatment group have died, compared with 203 within the
standard treatment group. This is a difference of 54 deaths, or 3 per
1,000 participants each year, over an average of almost four years of
treatment. The death rates in both groups were lower than seen in
similar populations in other studies.
"A thorough review of the data shows that the
medical treatment strategy of intensively reducing blood sugar below
current clinical guidelines causes harm in these especially high-risk
patients with type 2 diabetes," said Elizabeth G. Nabel, M.D., director,
NHLBI. "Though we have stopped this part of the trial, we will continue
to care for these participants, who now will receive the less-intensive
standard treatment. In addition, we will continue to monitor the health
of all participants, seek the underlying causes for this finding, and
carry on with other important research within ACCORD."
In stopping this part of the trial, Nabel accepted
the recommendation of the 10-member Data and Safety Monitoring Board
(DSMB) an independent advisory group of experts in diabetes,
cardiovascular disease, epidemiology, patient care, biostatistics,
medical ethics, and clinical trial design that has been monitoring
ACCORD since it began. A specific charge of any DSMB is to monitor
participant safety.
ACCORD participants will continue to receive blood
sugar treatment from their study clinicians until the planned trial
conclusion in June 2009. Those participants in the intensive treatment
group will now be treated to the same A1C goals as those already in the
standard treatment group.
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Video Report |
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Major differences in blood-sugar control minorities/whites |
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 Sept.
27, 2007 - Watch video - Michele Heisler, M.D., MPA,
University of Michigan Medical School, about a new national
study documenting major differences in blood-sugar control among
African Americans, Latinos and whites with diabetes.
CLICK HERE |
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The intensive treatment group had a target blood
sugar goal, measured by hemoglobin A1C, of less than 6 percent. This is
similar to blood sugar levels in adults without diabetes. The standard
treatment group aimed for a target similar to what is achieved, on
average, by those with diabetes in the United States (A1C of 7 to 7.9
percent) and lower than at study entry.
"The ACCORD findings are important, but will not
change therapy for most patients with type 2 diabetes. Few patients with
high cardiovascular risk like those studied in ACCORD are treated to
blood sugar levels as low as those tested in this study, " said Judith
Fradkin, M.D., director, Division of Diabetes, Endocrinology, and
Metabolic Diseases at the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK). "People with diabetes should never adjust
their treatment plan or goals without consulting their health care
providers."
In ACCORD, intensive treatment group participants
achieved, on average, A1C values lower than standard treatment group
participants. Half of the participants in the intensive treatment group
achieved an A1C of less than 6.4 percent, and half of the participants
in the standard treatment group achieved an A1C of less than 7.5
percent. The average blood sugar levels for both groups were lower than
when they entered the study.
The ACCORD trial was designed to determine whether
intensively lowering blood sugar would reduce the risk of cardiovascular
events such as heart attack, stroke, or death from cardiovascular
disease, specifically in people with type 2 diabetes who are at
particularly high risk for a cardiovascular event.
Prior studies suggested that reducing blood sugar
to levels found in non-diabetic adults may reduce the rate of
cardiovascular diseases among those with diabetes. However, a randomized
clinical trial was needed to determine whether that hypothesis is
accurate.
"ACCORD is an important study intended to find new
answers to help people with type 2 diabetes reduce their high risk of
heart disease," said Denise G. Simons-Morton, M.D., Ph.D., NHLBI project
officer for ACCORD and a member of the ACCORD steering committee.
"Hypotheses about treatments to prevent
cardiovascular disease in people with type 2 diabetes need to be tested
in clinical trials such as ACCORD. The ACCORD results, along with
results from other studies, will contribute to determining what the
treatment goals should be in patients with various characteristics."
 Conducted at 77 sites nationwide and in Canada, the
trial includes adults between the ages of 40 and 82 at enrollment who,
in addition to type 2 diabetes, also have two or more other risk factors
for heart disease or had been diagnosed with heart disease before
entering the study. Thus, participants were included in the ACCORD trial
because they were at especially high risk more risk than is associated
with diabetes alone for having a heart attack, stroke, or of dying
from cardiovascular disease.
Participants, who on average had diabetes for 10
years at enrollment, were randomly assigned to either standard (5,123
participants) or intensive (5,128) blood sugar treatment goals. They
were also enrolled in one of two other ACCORD randomized clinical trials
examining effects of treatments for blood pressure or blood lipids;
those study components will continue. Participants had been followed for
2 years to 7 years at the time the intensive blood sugar control
treatment was stopped.
These results from ACCORD do not apply to patients
with type 1 (juvenile) diabetes, according to Fradkin. It is also
unclear whether the results apply to patients with recently diagnosed
type 2 diabetes or those whose cardiovascular risk is lower than the
participants studied in ACCORD.
Extensive analyses by ACCORD researchers have not
determined a specific cause for the increased deaths among the intensive
treatment group. Based on analyses conducted to date, there is no
evidence that any medication or combination of medications is
responsible.
Most participants in the intensive treatment group
achieved their lower blood sugar goals with combinations of Food and
Drug Administration-approved diabetes medications. For both the
intensive and standard treatment groups, study clinicians could use all
major classes of diabetes medications available: metformin,
thiazolidinediones (TZDs, primarily rosiglitazone), insulins,
sulfonylureas, exanatide, and acarbose.
"Because of the recent concerns with rosiglitazone,
our extensive analysis included a specific review to determine whether
there was any link between this particular medication and the increased
deaths. We found no link," said William T. Friedewald, M.D., ACCORD
Steering Committee Chair and Clinical Professor of Medicine and Public
Health at Columbia University.
ACCORD researchers will continue to monitor
participants and conduct additional analyses to try and explain the
findings. Investigators are preparing a report of the findings for a
peer-reviewed publication.
An estimated 21 million Americans have diabetes and
284,000 die from it each year. Sixty-five percent of the deaths are
related to cardiovascular causes. Type 2 diabetes increases the risk for
heart disease 2 to 4 times.
The National Diabetes Education Program, a program
of the NIDDK and the Centers for Disease Control and Prevention (CDC),
promotes the diabetes care guidelines of the American Diabetes
Association (ADA), which recommend an A1C goal of less than 7 percent
for most people with type 2 diabetes.
The ADA guidelines are based on established
evidence that blood sugar control to this level reduces microvascular
complications resulting from diabetes including eye, kidney, and nervous
system diseases in people with type 1 or type 2 diabetes, and reduces
cardiovascular disease in type 1 diabetes.
The guidelines also state that treatment goals
should be tailored to the individual. For example, a less stringent A1C
goal should be considered for people with severe or frequent low blood
sugar or with other medical conditions. These important ACCORD results
can now be considered in addition to the guidelines when individualizing
treatment.
NIDDK contributed funding and scientific expertise
to ACCORD. The NIH's National Institute of Aging and National Eye
Institute, as well as the CDC, are also contributing in order to conduct
sub-studies in ACCORD. The following companies provided study
medications, equipment, or supplies: Abbott Laboratories, Amylin
Pharmaceuticals, AstraZeneca LP, Aventis Pharmaceuticals, Inc., Closer
Healthcare, GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals, Inc.,
MediSense Products (Division of Abbott Laboratories), Merck & Company,
Inc., Novartis Pharmaceuticals, Inc., Novo Nordisk Pharmaceuticals,
Inc., and Omron Healthcare, Inc.
To arrange an interview with an NHLBI spokesperson,
please contact the NHLBI Communications Office at (301) 496-4236 or
email
nhlbi_news@nhlbi.nih.gov. To interview Dr. Friedewald on Wednesday,
please contact NHLBI; after February 6, contact Randee Sacks Levine at
Columbia University Office of Communications at 212-305-8044.
Part of the National Institutes of Health, the
National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and
supports research related to the causes, prevention, diagnosis, and
treatment of heart, blood vessel, lung, and blood diseases; and sleep
disorders. The Institute also administers national health education
campaigns on women and heart disease, healthy weight for children, and
other topics. NHLBI materials are available online at
www.nhlbi.nih.gov.
The National Institutes of Health (NIH) The
Nation's Medical Research Agency includes 27 Institutes and Centers
and is a component of the U.S. Department of Health and Human Services.
It is the primary federal agency for conducting and supporting basic,
clinical and translational medical research, and it investigates the
causes, treatments, and cures for both common and rare diseases. For
more information about NIH and its programs, visit
www.nih.gov.
More:
>>
National Diabetes Information Clearinghouse,
http://diabetes.niddk.nih.gov/
>>
National Diabetes Education Program
http://ndep.nih.gov/
>>
Your Guide to Living Well With Heart Disease,
http://www.nhlbi.nih.gov/health/public/heart/other/your_guide/living_well.htm
>>
ACCORD clinical trial website,
http://www.accordtrial.org/public/index.cfm
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