A drug made of metformin and Avandia is better at controlling blood sugar levels in children and adolescents with type 2 diabetes than metformin alone, but the serious risks associated with Avandia raise concerns about the new drug combo.
Avandia is a type 2 diabetes medication that was severely restricted by the Food and Drug Administration (FDA) in 2010 after the drug was linked to fatal heart attacks. Actos, another type 2 diabetes medication, is in the same class of medications and was recently linked to bladder cancer.
The new study, called the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY), was designed in 2002, before heart risk or cancer concerns were raised about Avandia or Actos. The study was almost completed when the FDA placed restrictions on Avandia and issued warnings for Actos.
The TODAY study was developed to help identify safe and effective type 2 diabetes treatment options for young people in response to the rise in childhood obesity and the dramatic increase in type 2 diabetes in children and teenagers. Typically, failure rates of type 2 diabetes medications in children are higher than in adults.
The TODAY study involved 699 patients, ages 10-17, who had been diagnosed with diabetes about eight months prior. Patients were randomly given metformin alone, metformin plus Avandia, or metformin plus lifestyle intervention focused on weight loss. Researchers found that metformin plus lifestyle changes offered an immediate benefit but that metformin plus Avandia offered the best control of blood sugar levels.
Overall, the side effects were not considered serious and occurred in 19 percent of patients. The largest number of side effects was seen in the metformin-plus-lifestyle change group.
Source: ABC News