The TODAY study (NEJM 2012; 366: 2247-56 and editorial 2315-16) =Treatment Options for Type 2 Diabetes in Adolescents and Youth.
While the study has a catchy acronym, the findings are disturbing. Eligible patients (n=699) were 10 to 17 years old were followed on average over 3.86 years; they were divided into three groups:
- Metformin 1000mg BID –48% achieved primary outcome (glycated hemoglobin <8% for at least 6 months).
- Metformin with lifestyle changes –53% achieved primary outcome. The lifestyle counseling that patients received in the study likely exceeded the typical counseling that most patients receive in clinical practice.
- Metformin with rosiglitazone (4mg BID) –61% achieved primary outcome. While this group had the best glycemic response, this group also had the greatest increase in BMI.
Other findings:
Comorbid conditions were common:
- Hypertension: at baseline in 81 (11.6%) and new cases during study 155 (22.2%)
- Dyslipidemia (LDL): at baseline in 23 (3.3%) and new cases during study 49 (7%)
- Triglyceridemia: at baseline in 127 (18.2%) and new cases during study 70 (10%)
- Microalbuminurina: at baseline in 44 (6.3%) and new cases during study 72 (10.3%)
Frequent adverse events noted with medications (Table 2 in study): gastrointestinal symptoms noted in about half of all study participants in each group, rash noted in about 40%, and elevated LFTs in about 40%.
Take home messages (borrowed from editorial):
“Most youth with type 2 diabetes will require multiple oral agents or insulin therapy within a few years after diagnosis”
“Fifty years ago, children did not avoid obesity by making healthy choices; they simply lived in an environment that provided fewer calories and included more physical activity.”
“Public-policy approaches–sufficient economic incentives to produce and purchase healthy foods and to build safe environments that require physical movement…will be necessary to stem the epidemic of type 2 diabetes and its associated morbidity.”
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