Rosiglitazone effective add-on to metformin in diabetic youths
MedWire News: Adding rosiglitazone to metformin provides more durable glycemic control in children and adolescents with Type 2 diabetes than metformin alone, show study findings.
The metformin plus rosiglitazone regimen is also more effective than adding intensive lifestyle intervention to metformin, say Kathryn Hirst (George Washington University, Rockville, Maryland, US) and colleagues.
"Because the risk of microvascular and macrovascular complications in adults increases with both the duration of diabetes and lack of glycemic control, it is imperative to achieve and sustain metabolic control in youth," write the researchers in TheNew England Journal of Medicine.
However, "addressing the physiological and psychological changes that normally occur during adolescence requires a high level of family involvement and makes the achievement of stringent treatment goals especially difficult in the case of adolescents with diabetes," they add.
The team compared the efficacy of metformin monotherapy with two alternative approaches in participants, aged 10‑17 years, from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study.
The participants (n=699), who all had recent-onset Type 2 diabetes, were randomly assigned to metformin 1000 mg twice daily, metformin plus rosiglitazone 4 mg twice daily, or metformin plus an intensive lifestyle intervention program that focused on weight loss through family-based changes in eating and physical activity.
Participants were followed-up over a mean of 3.9 years for time to treatment failure, defined as a glycated hemoglobin level of over 8% persisting for 6 months or sustained metabolic decompensation requiring insulin.
The researchers report that 319 (45.6%) of the participants had treatment failure, with a median time to treatment failure of 11.5 months.
Overall, rates of failure were 51.7% with metformin alone, 38.6% with metformin plus rosiglitazone, and 46.6% with metformin plus lifestyle intervention.
The metformin and rosiglitazone combination was associated with a substantial 25.3% greater decrease in treatment failure than metformin alone, whereas the treatment failure rate did not differ significantly with metformin plus lifestyle intervention compared with metformin alone.
The team suggests that the majority of youth with Type 2 diabetes may require combination treatment or insulin therapy within a few years after diagnosis.
"Whether the effect shown in this study is specific for rosiglitazone, a more general effect of thiazolidinediones, or a feature of combination therapy is unclear," say the researchers. "This question is of particular importance, given the currently restricted status of rosiglitazone in the United States and Europe."
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By Sally Robertson