In a nutshell
The TODAY study (Treatment Options for Type 2 Diabetes in Adolescents and Youth) compared 3 different therapy approaches in children and adolescence recently diagnosed with T2DM (within the last 2 years). They found that combined Metformin/Rosiglitazone treatment was most effective in maintaining blood sugar control, whereas Metformin along with lifestyle modifications (i.e. diet and sports) had the best effect on weight loss.
Some background
As the numbers of obese children and adolescents rise, more and more are diagnosed with type 2 diabetes (T2DM). Glycemic control is the attemp to keep blood sugar levels as close to normal as possible. It is measured by glycated hemoglobin (HbA1c), which reflects the average blood glucose levels for the past three months. Achieving glycemic control in adolescence is challenging due to physiological and psychological changes at that age. Poor management of diabetes in childhood raises the risk for the development of complications as adults.
Methods & findings
The study included almost 700 participants between the ages of 10-17 years old who were randomly divided into 3 treatment groups. The first group was treated with the oral medication Metformin (Glucophage). The second group was treated with Metformin combined with Rosiglitazone (Avandia). The third group was treated with Metformin combined with a lifestyle-intervention program focusing on weight loss through eating and activity behaviors.
All participants received diabetes education and had a parent or an adult caregiver ensuring adherence to their therapy regimen.
The goal of treatment was to achieve glycemic control, defined as a HbA1c level of 8% and below.
The results showed that almost half of all participants (45.6%) achieved the target glycemic control during the study period (almost 4 years). When comparing treatment options, glycemic control was obtained in approximately 61%, 53% and 48% in Metformin/Rosiglitazone, Metformin/lifestyle modification and Metformin alone groups, respectively. Thus, Metformin plus Rosiglitazone was the superior therapy in this study population. It was particularly effective in girls with T2DM.
Body mass index (BMI) was monitored for up to 60 months. Metformin plus lifestyle modification was the most effective approach for BMI reduction within the critical first 6 months of treatment, when weight-loss interventions typically have their greatest impact. In contrast, the combination Metformin/Rosiglitazone caused weight gain.
Adherence to the medication regimen was successful in 84% of the participants at 8 months and declined to 57% after 5 years.
The bottom line
In the present study, combined treatment of Metformin plus Rosiglitazone was the most successive treatment in achieving glycemic control, but with the cost of a relative weight gain. On the other hand, Metformin plus lifestyle modification was the superior intervention for weight reduction. All three treatment options are viable for children and adolescents with newly diagnosed T2DM.
The fine print
Annotation: Rosiglitazone had know cardiovascular risks (including heart attacks) and should be used cautiously.
Patients should read Rosiglitazone – FDA safety announcement .
Published By :
The New England Journal of Medicine
Date :
Jun 14, 2012