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GLP-1 therapy shows promise for severely obese adolescents
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Despite recent FDA approvals for the adult population, obesity therapies for adolescents are limited. However, preliminary data from a 3-month trial examining the effects of a glucagon-like peptide-1 receptor agonist on BMI in severely obese adolescents have yielded positive findings.
Researchers conducted a 3-month, double blind, randomly assigned, placebo-controlled, multicenter trial followed by a 3-month open-label extension trial. Patients (n=26) aged 12 to 19 years with severe obesity were enrolled and received lifestyle modification counseling and randomly administered exenatide (Bydureon, Amylin Pharmaceuticals) or placebo injection twice daily.
Data indicate that 22 patients finished the trial, and exenatide encouraged a greater reduction in BMI percentage change compared with placebo (–2.7%; 95% CI, –5.02 to –0.37). Similarly, there were absolute changes to BMI (–1.13; 95% CI, –2.03 to –0.24) and body weight (–3.26 kg; 95% CI, –5.87 to –0.66).
In an accompanying editorial, Jeffrey B. Schwimmer, MD, of the University of California, San Diego School of Medicine and department of gastroenterology at Rady Children’s Hospital in San Diego, wrote that one challenge for pediatric obesity trials is determining the appropriate level of intervention.
“Ultimately, there is a need to better link weight-related outcome parameters to other clinical outcomes. Until then, controversy will remain in the choice of outcome for pediatric weight loss studies,” he wrote.
Schwimmer also wrote on the importance of two new drugs — lorcaserin (Belviq, Eisai) and phentermine-topiramate (Qsymia, Vivus) — that were recently approved by the FDA for the treatment of obesity in adults.
“Data on the safety and efficacy of these medications are needed in the pediatric population,” he wrote.
The study researchers concluded that their findings demonstrate that GLP-1 receptor agonist therapy reduced BMI in adolescent patients with severe obesity.
For more information:
Kelly AS. JAMA Pediatr. 2013;doi:10.1001/jamapediatrics.2013.1045.
Schwimmer JB. JAMA Pediatr. 2013;doi:10.1001/jamapediatrics.2013.1661.
Disclosure: Two of the researchers report funding from Amylin and Eli Lilly, and one has served on a pediatric obesity advisory board (clinical trial design) for Novo Nordisk.
Perspective
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Steven R. Smith, MD
It is predicted that by 2030, 10% of Americans will be classified as severely obese by having a BMI greater than 40 kg/m2. Severe obesity is particularly difficult to treat and lifestyle modification is often inadequate.
Bariatric surgery is effective in adolescence, but many are reluctant to take that route. Apart from lifestyle and surgery, obese adolescents, their parents and their physicians have few options.
The recent approval of two medications treating adult obesity increased interest in pharmacotherapy. Metformin improves glycemia, prevents diabetes in adults and has a good safety profile in adults. On average, metformin produces modest reductions in body weight, but some adolescents respond very well.
Like metformin, exenatide (an injectable GLP-1 analogue) also has a good safety profile in adults making it a logical starting point. The work of Kelly et al suggests that exenatide might also be effective in severely obese adolescents. On average, adolescents treated with exenatide lost about 3 kg over 3 months, improved glycemia and reduced blood pressure. As in adults, there is large variation in the degree of weight lost and effects on BP.
This is one the first of many studies to examine the use of drugs to treat severe obesity in adolescents, but given the trends it will not be the last.
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