Rosiglitazone A Viable Option for Children

Children assigned rosiglitazone lowered A1c by .25% over those on metformin but had average weight gain of 3 kg vs. no weight gain among those assigned metformin.

Rosiglitazone seems safe and effective for lowering glucose levels in pediatric patients with type 2 diabetes.

Results of a study conducted by researchers at the Children’s Hospital in Montefiore, N.Y., indicated that rosiglitazone could be an important treatment option for this population. Researchers said these findings are important because treatment options for younger patients with type 2 diabetes are limited. As the global prevalence of type 2 diabetes in children continues to increase, the need also increases for treatment and prevention options.

Researchers enrolled 195 children, aged 8 to 17, with type 2 diabetes. The average age of participants was 14; average weight, 90 kg; average BMI, 33.6. All patients had been previously treated with diet and exercise or oral monotherapy.

The first phase of the 24-week trial was a four-week run-in/wash-out period; all participants were given placebo during that time. At the end of this phase, patients were randomized to treatment with 2 mg rosiglitazone (Avandia, GlaxoSmithKline) twice daily or 500 mg metformin twice daily.

At week eight, doses of both regimens were increased. Patients in the rosiglitazone group were assigned 4 mg twice daily; patients in the metformin group were assigned 1,000 mg twice daily. The treatment goal was to attain fasting plasma glucose levels < 126 mg/dL.

At the time of randomization, HbA1c levels were higher in the metformin group. Patients randomized to the rosiglitazone group had an average HbA1c level of 7.88%; the average in the metformin group at this time was 8.17%.

But by the end of the 24-week study, significant reductions in HbA1c levels were recorded in both groups. The average decrease in the rosiglitazone group was 0.25% and 0.55% in the metformin group.

Reductions in patients’ HbA1c during the run-in period may have been influenced by prior oral monotherapy. But by the end of the 24-week study, the HbA1c levels of all patients were similar, regardless of previous therapy.

Effects of rosiglitazone in pediatric patients were similar to those seen in adults, the researchers reported. The treatment was safe and well-tolerated; the only adverse event was mild peripheral edema in one patient assigned rosiglitazone.
Patients treated with rosiglitazone had an average weight gain of 3 kg at the end of the study vs. no weight gain among patients treated with metformin.

Saenger P, Kenneth J, Guissou D, et al. Benefits of rosiglitazone in children with type 2 diabetes mellitus. Presented at the European Society for Paediatric Endocrinology/Lawson Wilkins Pediatric Endocrine Society 7th Joint Meeting. Sept. 21-24, 2005. Lyon, France.