medwireNews: Adding liraglutide 3.0 mg to lifestyle therapy increases weight loss in obese adolescents, show the findings of a placebo-controlled phase 3 trial.
Over the course of 56 weeks of treatment, the BMI standard deviation score fell by an average of 0.23, from a baseline of 3.14, in the 125 study participants taking liraglutide versus no change from a baseline of 3.20 in the 126 adolescents taking placebo, which was a significant between-group difference.
“Although evidence in children is limited, a change in the BMI standard-deviation score of at least 0.20 has been suggested to be clinically meaningful”, write Aaron Kelly (University of Minnesota, Minneapolis, USA) and study co-authors in The New England Journal of Medicine.
BMI fell by 1.39 kg/m2 in the liraglutide group, compared with a 0.19 kg/m2 increase in the placebo group, and the corresponding changes in bodyweight were a 2.26 kg reduction versus a 2.25 kg increase, despite all participants receiving nutrition and physical activity advice.
The researchers note the bodyweight changes are similar to the treatment effect seen for liraglutide in adults.
However, in line with findings in adults, there was a rebound effect during an additional 26 weeks of follow-up after treatment ended; the BMI standard deviation score increased by an average of 0.22 among adolescents who had been taking liraglutide compared with 0.07 among those in the placebo group.
“Some studies indicate that even temporary weight loss may have long-term benefits, but the extent to which this applies in adolescents and the extent to which long-term adherence to pharmacotherapy can be expected are unknown”, say Kelly and team.
Indeed, they found that just seven of 112 serum samples taken for pharmacokinetic analysis at week 8 had undetectable levels of liraglutide, compared with 29 of 98 samples taken at week 56, “a finding that suggests decreasing adherence to the medication”.
The study participants had an average age of approximately 14.5 years, approximately 60% were female and around a quarter had prediabetes or type 2 diabetes. Of those taking liraglutide, 82.4% achieved escalation to the full dose of 3.0 mg/day.
The researchers found the safety profile of liraglutide to be similar in their adolescent study participants as it is in adults, with gastrointestinal complaints being the most frequent issue, reported by 64.8% versus 36.5% of liraglutide and placebo users, respectively.
However, they stress that 13 participants taking liraglutide discontinued treatment because of side effects, primarily gastrointestinal, whereas none in the placebo group discontinued.
“The higher frequency of gastrointestinal adverse events observed with liraglutide suggests that this treatment may not be suitable for all patients”, the team concludes.
By Eleanor McDermid
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N Engl J Med 2020; doi:10.1056/NEJMoa1916038