FRIDAY, June 6 (HealthDay News) -- Two studies looking at the
benefits of aggressively lowering blood sugar in people with type 2
diabetes have come to significantly different conclusions: One
study found a 21 percent
reduced risk for kidney disease, while the other found a 22
percent
increased risk of death.
However, the first study found no increased risk of death by
aggressively lowering blood sugar levels. And diabetes experts
noted that the increased death risk found in the second study
probably owed to the fact that the participants were "high-risk
patients" -- more than one-third had suffered a heart attack or
stroke before the trial began and the remainder had major
cardiovascular risk factors. So the findings wouldn't apply to most
people with type 2 diabetes, they note.
Both studies were presented Friday at the American Diabetes
Association's annual meeting in San Francisco, and will be
published in the June 12 issue of the
New England Journal of Medicine.
The goal of both studies was to lower blood sugar levels through
the aggressive use of drug therapy. In the second study, the goal
was to reach an A1C level of less than 6 percent in the intensive
therapy group, while the standard group goal was between 7 percent
and 7.9 percent. When the U.S.-government sponsored trial was
terminated 18 months early in February, the median A1C was 6.4
percent in the intensive group, compared to 7.5 percent in the
standard group. A1C is a measure of blood glucose over the previous
two to three months.
In the first study, called ADVANCE (Action in Diabetes and
Vascular Disease), researchers found that among those who underwent
intensive blood sugar control, there was a 21 percent reduced risk
of developing kidney disease.
"Intensive glucose control significantly reduces serious
vascular complications in diabetes, primarily kidney disease," lead
researcher Dr. Anushka Patel, director of the Cardiovascular
Division at the George Institute for International Health in
Sydney, Australia, said during a teleconference Friday.
"There were no clear effects on macrovascular complications such
as heart attack or stroke," Patel said. "Most importantly, using
the strategy we employed for intensive glucose control, there was
no increased risk of death."
In the study, 11,140 high-risk patients with type 2 diabetes
either underwent intensive blood sugar control or standard
treatment. By the end of the trial, most of the patients in the
intensive care group were on several drugs, including insulin.
The ADVANCE researchers did not find any effect on
cardiovascular disease between the two groups. The study also
didn't find any increased risk of death for either group, unlike
the second trial.
"These findings confirm what we already know -- that
microvascular complications, and particularly kidney disease, is
less with people whose blood sugar is intensively controlled," said
Dr. Spyros Mezitis, an endocrinologist at Lenox Hill Hospital in
New York City.
"This trial reassures us that we should be intensively
controlling the blood sugar of patients so that we avoid
microvascular complications," Mezitis added.
In the second study, called ACCORD (Action to Control
Cardiovascular Risk in Diabetes), researchers found a 22 percent
increased risk of death among patients receiving intensive blood
sugar control, compared with those receiving standard
treatment.
"In people with type 2 diabetes who are at high risk for
cardiovascular disease, a therapeutic strategy that targets a blood
sugar level below current recommendations increases mortality,"
ACCORD researcher Dr. Hertzel C. Gerstein, a professor in the
Department of Medicine at McMaster University in Hamilton, Ontario,
Canada, said during the teleconference.
"The reasons that people died was varied and there was no one
reason that people died, and there was no clear difference in the
actual cause of death in the intensive or standard group," Gerstein
said. "Many analyses have been done to try to see if a reason could
be found to explain why there was this mortality finding. At this
point in time, none of these analyses have identified any one
reason."
In the study, 10,251 patients with type 2 diabetes received
intensive blood sugar control or standard treatment. During the
trial, there was a 35 percent higher rate of death from
cardiovascular events among patients in the intensive treatment
group. However, those in the intensive care group also had a 24
percent lower risk of having a nonfatal heart attack. There was no
difference between the groups in the risk for nonfatal stroke or
heart failure, the researchers found.
Despite the findings of the ACCORD trial, one diabetes expert
doesn't think they apply to most people with type 2 diabetes.
"Early and aggressive blood glucose control remains the optimum
treatment approach for people with type 2 diabetes," said Dr. James
A. Underberg, a clinical assistant professor of medicine at New
York University Medical School.
Underberg said the results of the trial reflected the patient
population in the study -- people with heart problems -- and not
the dangers of aggressively lowering blood sugar.
"Data showing that high-risk patients are at greater risk for
heart disease are not surprising, and should be considered a
non-event for the average patient," Underberg said. "It's important
that we don't lose sight of the benefits of lowering blood sugar,
including fewer long-term microvascular complications."
"As I've always told my patients with type 2 diabetes, it's
important to achieve and maintain your blood sugar goals," he said.
"ACCORD hasn't changed any of that. The trial was conducted in a
select patient population, which is just not reflective of the
majority of the millions of Americans with type 2 diabetes."
In a third report from the meeting, a study of 1,791 U.S.
veterans with type 2 diabetes found that aggressive blood glucose
control reduced the risk of cardiovascular disease, but the risk
reduction wasn't significant.
More information
To learn more about type 2 diabetes, visit the
American Diabetes Association.