1. The combination of liraglutide and lifestyle therapy was shown to significantly reduce body mass index (BMI) standard-deviation score compared to the placebo group.
2. The use of liraglutide as adjuvant therapy was shown to cause a higher frequency of gastrointestinal adverse events.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Obesity is a chronic and progressive disease with few treatment options for the pediatric patient population. The first-line treatment is lifestyle therapy, which has yielded poor results, and bariatric surgery is seldom performed within this patient population. Pharmacologically, only orlistat and phentermine have been approved by the Food and Drug Administration. As such, liraglutide presents another treatment option in combination with lifestyle therapy for adolescents where obesity is of concern. The study evaluated the efficacy and safety of subcutaneous liraglutide in combination with lifestyle therapy for weight management in adolescents with obesity. All participants received lifestyle therapy and were randomized to receive liraglutide or placebo. The study found the addition of liraglutide with lifestyle therapy led to a greater reduction in the BMI standard-deviation score, a relative measure of BMI adjusted for age and sex, compared to the placebo group. However, the participants in the liraglutide group presented with a higher frequency of gastrointestinal adverse effects compared to the placebo group.
This randomized, double-blind, phase 3, trial was limited by the lack of cardiometabolic profiling conducted throughout the study as secondary outcomes. Since a major concern of childhood obesity surrounds cardiovascular outcomes, cardiometabolic profiling may have elucidated the effect of liraglutide treatment on cardiac health. Nonetheless, this study was strengthened by the high retention rate and evenly matched sample size. For physicians, these findings highlighted an alternative therapy to be prescribed to pediatric patients to complement the weight management through lifestyle therapy.
Click to read the study in NEJM
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