A combination of two diabetes drugs,
metformin and rosiglitazone, was more effective in treating youth with
recent-onset type 2 diabetes than metformin alone, a study funded by the
National Institutes of Health (NIH) has found. Adding an intensive lifestyle
intervention to metformin provided no more benefit than metformin therapy
alone.
The
study also found that metformin therapy alone was not an effective treatment
for many of these youth. In fact, metformin had a much higher failure rate in
study participants than has been reported in studies of adults treated with
metformin alone.
The
Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study is
the first major comparative effectiveness trial for the treatment of type 2
diabetes in young
people. TODAY was funded by the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), part of NIH. Study results will appear
in the New
England Journal of Medicine.
"The
results of this study tell us it might be good to start with a more aggressive
drug treatment approach in youth with type 2 diabetes," said Philip
Zeitler, M.D., Ph.D., the TODAY study chair and a pediatric endocrinologist at
Children's Hospital Colorado, Aurora. "We are learning that type 2
diabetes is a more aggressive disease in youth than in adults and progresses
more rapidly, which could be why metformin alone had a higher than expected
failure rate."
The
TODAY study tested how well and for how long each of three treatment approaches
controlled blood
glucose levels in youth enrolled from ages 10 to 17 with type 2
diabetes. Participants were randomly assigned to one of three treatment groups:
metformin alone, metformin and rosiglitazone together, and metformin plus
intensive lifestyle changes aimed at helping participants lose weight and
increase physical activity.
The
study found that treatment with metformin alone was inadequate for maintaining
acceptable, long-term, blood glucose control in 51.7 percent of youth over an
average follow-up of 46 months. The failure rate was 38.6 percent in the
metformin and rosiglitazone group, a 25.3 percent reduction from metformin
alone. In the metformin plus lifestyle group the failure rate was 46.6 percent.
The
childhood obesity epidemic has led to the emergence of type 2 diabetes in
youth. However, because type 2 diabetes has been primarily an adult illness,
information about how to effectively treat youth is limited, and pediatric
diabetes experts have had to rely on what is known about adult treatment.
Currently,
metformin is the standard treatment for young people with type 2 diabetes and
the only oral drug approved for this use by the U.S. Food and Drug Administration.
The
longer a person has type 2 diabetes, the greater the likelihood of developing
complications including coronary artery disease, stroke, kidney and eye
disease, and nerve damage, making it critical for young people with type 2
diabetes to quickly achieve and sustain control of their blood glucose.
"This
important study provides much-needed information about how to treat type 2
diabetes in young people. Earlier studies in adults have shown that early,
effective treatment can prevent serious and costly diabetes complications later
in life," said NIDDK Director Griffin P. Rodgers, M.D. "Longer-term
follow up will be important to understand whether more aggressive therapy for
youth with type 2 diabetes will yield long-term benefits as they move into
adulthood."
In
September 2010, the FDA restricted the use of rosiglitazone because of studies
linking the medicine to a higher risk of heart attacks and stroke in adults.
The TODAY Data Safety and Monitoring Board—an independent group of health and
science experts—carefully examined all safety data for TODAY participants and
recommended that the study should continue to test rosiglitazone. Rosiglitazone
is sold commercially as Avandia.
Studies
have shown lifestyle-change programs to be effective in improving blood glucose
control for adults with type 2 diabetes. However, the TODAY lifestyle
intervention—a family-based weight-management program that included intensive
education and activities delivered one-on-one by trained study staff—added no
benefit to the metformin therapy. Some youth lost weight during the study, but
the majority did not.
"Despite
a rigorous lifestyle
intervention, we were unable to achieve sustained lifestyle changes in
these youth, though similar strategies have proven effective in adults,"
said Barbara Linder, M.D., Ph.D., NIDDK senior advisor for childhood diabetes research.
"TODAY investigators will look more closely at those youth who succeeded
in losing weight to better understand how to achieve effective lifestyle change
in this population."
The
study enrolled 699 youth who had type 2 diabetes for
less than two years and a body mass index (BMI) at the 85th percentile or
greater. BMI is a measurement of weight in relation to height. Overweight
children have a BMI at the 85th to 94th percentile for their age and sex, while
obesity is defined as a BMI at the 95th percentile or more. The TODAY
participants had an average BMI at the 98th percentile.
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