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Title: No Benefits Seen With Metformin for Insulin Resistance in Obese Children: Presented at ECE

"No Benefits Seen With Metformin for Insulin Resistance in Obese Children: Presented at ECE"

By Chris Berrie BERLIN -- May 7, 2008 -- Use of metformin does not appear to improve insulin resistance compared with placebo among children and adolescents with obesity, according to the largest prospective, randomised, placebo-controlled study of metformin use in these patients to date. This finding was presented by principal investigator Susanna Wiegand, MD, Head, Obesity Department, Paediatric Endocrinology and Diabetology, Charité Children's Hospital, Universitätsmedizin Berlin, Berlin, Germany, here on May 5th at the 10th European Congress of Endocrinology (ECE). Features of the metabolic syndrome are already present in young obese patients, and impaired glucose metabolism with insulin resistance is an alarming sign of their existing comorbidity. Metformin is used world-wide for treatment of insulin resistance, including in obese adolescents, but few randomised, controlled trials have evaluated its use in this population, Dr. Wiegand noted. These previous randomised studies in childhood cohorts included few patients, but indicated potential beneficial effects of metformin, she said. However, they showed low levels of significance. Dr. Wiegand and colleagues therefore investigated the use of metformin in a larger childhood obesity cohort to determine its effect in patients following a nonpharmacological, multiprofessional intervention programme. Study subjects were 243 nondiabetic children and adolescents aged 10 to 17 years and diagnosed with insulin resistance (homeostasis model assessment [HOMA] >97%) and/or impaired glucose tolerance. After following an initial 6-month weight-reduction programme, patients with unsuccessful weight reduction and persistent insulin resistance were randomised to receive either placebo or metformin 500 mg twice daily for 6 months. These 67 patients had a mean age of 13.8 years, 32.9% were male, mean body mass index (BMI) was 32.5 kg/m[², and homeostasis model of assessment (HOMA) was 5.00.

Patients were assessed at randomisation and after 3 and 6 months of treatment for anthropometric parameters and metabolic parameters of fasting blood samples, as well as monitoring for adverse effects.

After 6 months of treatment, the greater reductions seen in BMI for placebo versus metformin (36% vs 53%, respectively) and HOMA (54% vs 73%) did not reach statistical significance. This was the same for all changes seen between placebo and metformin groups for all weight and glucose metabolism parameters.

This lack of significant differences in all tested parameters does not support the use of metformin to improve insulin resistance in obese children, at least in those who participate in multiprofessional obesity programmes.

"This is an important result, because metformin is widely used, and you really have to make sure that it is only used if it is indicated," Dr. Wiegand noted. "For us the question is answered now: it is not a drug you should use in general in this group of patients."

Funding for this study was provided by Merck & Co.

[Presentation title: Prospective, Placebo-Controlled, Randomised Treatment of 67 Obese Children/ Adolescents With Metformin. Abstract P566]

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