Pediatric News - Sibutramine can offset pediatric weight disorders
LAS VEGAS — Sibutramine (Meridia), an adult diet drug, can help control the weight of children with hypothalamic obesity and other syndromes that make behavioral interventions ineffective, results from a small, double-blind, placebo-controlled trial suggest.
Claude Marcus, M.D., reported statistically significant differences in reduction of body mass index (BMI) when the children were on sibutramine, compared with when they were on placebo. Triglyceride levels also declined significantly with sibutramine, Dr. Marcus said at the annual meeting of the North American Association for the Study of Obesity.
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“These are very difficult patients to treat,” explained Dr. Marcus of the Karolinska Institute in Stockholm where the trial was conducted.
These patients are extremely resistant to behavioral treatments that help normal children, and often have a very low quality of life, he said at the meeting, which was cosponsored by the American Diabetes Association.
The trial enrolled 50 obese young peon pie who were 7 to 20 years old and had a range of disorders: mental retardation or attention-deficit-hyperactivity disorder (21 children), central nervous system lesions (10), Lawrence-Moon-Bardet-Biedl syndrome (6), Prader-Willi syndrome (4), myelomeningocele (4), Mb Down syndrome (3), and mutation in the MC4R gene (2).
Half of the children started on sibutramine and crossed over to placebo after 20 weeks. The other half started on placebo and switched to sibutramine. In 38 children, doses were escalated from 10 to 15 mg because of unsatisfactory weight loss, but Dr. Marcus said the best dose is still uncertain.
The group that started on sibutramine experienced a 0.72 reduction in BMI while on the drug, followed by a 0.43 rebound when they went on placebo. Conversely, the group that started on placebo lost 0.06 in BMI during the first half of the trial and 0.68 when they went on sibutramine.
Dr. Marcus acknowledged that these amounts are small, compared with other weight-loss studies, but described them as significant for the population. He said sibutramine slowed weight gain in some children who were in a weight-increase phase, while having an extreme effect in others.
“One child lost 40 kilos,” he said, cautioning that the subgroups in the study were too small to make comparisons by disorder.
Sibutramine was generally well tolerated, according to Dr. Marcus. Five children dropped out of the study–three because of recurrence of CNS tumors and two because they did not comply with the treatment.
Four youngsters were on concurrent selective serotonin reuptake inhibitors (SS-RIs); no side effects were reported with the combination. Three children were diagnosed with severe depression while on placebo.
Dr. Marcus said the children are now off sibutramine because it is only approved for ages 16 and older. He announced plans to start another dose trial that would enable them to resume treatment.
The trial was supported by the Swedish Research Council, the Swedish Children’s Cancer Foundation, Abbott Scandinavia AB (distributor of sibutramine), and the Freemasons in Stockholm Foundation for Children’s Welfare.
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