Embargo expired: 2/4/2013 4:00 PM EST
Source Newsroom: American Medical Association (AMA)
Newswise — Preliminary evidence from a clinical trial suggests that treatment with glucagon-like peptide-1 (GLP-1) receptor agonists was associated with reduced body mass index and body weight in adolescents with severe obesity, according to a report published Online First by JAMA Pediatrics, a JAMA Network publication.
GLP-1 receptor agonist therapy, approved for adults with type 2 diabetes mellitus, reduces body weight by enhancing satiety and suppressing appetite, even in patients without diabetes, according to the study background.
Aaron S. Kelly, Ph.D., of the University of Minnesota Medical School, Minneapolis, and colleagues conducted a three-month, placebo-controlled trial followed by a three-month open-label extension during which medication was offered to all patients. A total of 22 patients (12 to 19 years of age) completed the trial, in which the medication exenatide was administered subcutaneously (injected).
“The results of this clinical trial extend the findings of our previous pilot and feasibility study and offer additional evidence, within the context of a randomized, placebo-controlled trial, that treatment with a GLP-1 receptor agonist significantly reduces BMI and body weight in adolescents with severe obesity,” the authors note.
Exenatide caused a greater reduction in BMI compared with placebo (-2.7 percent). Researchers also observed a further reduction in BMI during the open-label phase for those patients initially randomized to exenatide (cumulative BMI reduction of 4 percent). The medication also resulted in a reduction, on average, in systolic blood pressure of -6mm HG, although researchers note it did not reach the level of statistical significance.
“In conclusion, data from the current study provide evidence that GLP-1 receptor agonist treatment reduces BMI and elicits a potentially meaningful reduction in SBP in adolescents with severe obesity,” the authors conclude.
(JAMA Pediatr. Published online February 4, 2013. doi:10.1001/jamapediatrics.2013.1045. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor’s Note: Authors made conflict of interest disclosures. Funding for this study was provided by a Community Health Collaborative grant from the University of Minnesota Clinical and Translational Science Institute, by an award from the National Center for Research Resources and by a grant from the National Center for Advancing Translational Sciences of the National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Editorial: Clinical Trials for Adolescent Obesity
In a related editorial, Jeffrey B. Schwimmer, M.D., of the University of California, San Diego, writes: “The need for medication(s) to treat pediatric obesity stems from the frequency and severity of childhood obesity and its complications.”
“How to select which children merit treatment with medication and are most likely to benefit from a given treatment is a pressing issue for both clinical care and the research studies on which that care will be based,” Schwimmer continues.
“Moving beyond the results of the current study, it is noteworthy that two new drugs were recently approved by the FDA [U.S. Food and Drug Administration] for the treatment of obesity in adults. Data on the safety and efficacy of these medications are needed in the pediatric population,” he concludes.
(JAMA Pediatr. Published online February 4, 2013. doi:10.1001/jamapediatrics.2013.1661. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor’s Note: This work was supported in part by grants from the National Center for Research Resources for the Clinical and Translational Research Institute, University of California, San Diego. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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