Posted by Carla Rothaus
In the trial by Kelly et al., was liraglutide beneficial in adolescents with obesity?
Kelly et al. conducted a randomized, double-blind, placebo-controlled, phase 3 trial that evaluated the efficacy and safety of subcutaneous liraglutide (3.0 mg) as an adjunct to lifestyle therapy for weight management in adolescents with obesity. Read the NEJM Original Article here.
Q: How often is obesity before puberty associated with obesity during adulthood?
A: More than 70% of persons who have obesity before puberty will also have obesity as adults, which underscores the need for effective and durable interventions with adequate safety profiles early in life. In pediatric patients, first-line treatment for obesity is typically lifestyle therapy, which often yields poor responses.
Q: What pharmacotherapies are available to treat obesity in pediatric patients?
A: Orlistat and phentermine are the only Food and Drug Administration–approved pharmacotherapies for the treatment of obesity in pediatric patients, and they can be used only in persons 12 years of age or older and in persons older than 16 years of age, respectively. The European Medicines Agency has not approved any pharmacotherapeutic agents for obesity in pediatric patients. Bariatric surgery is offered to adolescents only when they have severe obesity, and it is performed infrequently. Thus, pharmacologic treatment options that can be used as adjuncts to lifestyle therapy in adolescents with obesity are of interest.
Morning Report Questions
Q: In the trial by Kelly et al., was liraglutide beneficial in adolescents with obesity?
A: Liraglutide was superior to placebo with regard to the change from baseline in the body-mass index standard-deviation score at week 56 (the primary endpoint), with an estimated treatment difference of −0.22 (95% confidence interval [CI], −0.37 to −0.08; P=0.002). In contrast to trials involving adults and to an observational trial involving adolescents, this trial showed no substantial differences between the liraglutide group and the placebo group in cardiometabolic markers or results on quality-of-life assessments. In line with observations from placebo-controlled trials of liraglutide (3.0 mg) in adults, weight regain was seen in the 26-week follow-up period, reinforcing the concept that obesity is a chronic disease that requires continued treatment.
Q: What adverse events were most often reported with liraglutide in the trial by Kelly et al.?
A: Gastrointestinal events — including nausea, vomiting, and diarrhea — were the events most frequently reported with liraglutide; these events were more common with liraglutide than with placebo (occurring in 81 participants [64.8%] vs. 46 participants [36.5%], P<0.001), and they occurred primarily within the initial 4 to 8 weeks of the treatment period, during liraglutide dose escalation. There was a clear imbalance between groups in the frequency of adverse events that led to discontinuation of the trial treatment (occurring in 13 participants who were treated with liraglutide and none who were treated with placebo), which was primarily due to gastrointestinal side effects.
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