European Primary Care Cardiovascular Society

BMI standard deviation score reduced by GLP-1RA in obese adolescents

A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity

Literature - Kelly AS, Auerbach P, Barrientos-Perez M et al., - N Engl J Med. 2020. doi: 10.1056/NEJMoa1916038.

Introduction and methods

There is a need for effective, durable and safe interventions early in life for persons with obesity, as currently more than 70% of persons who have obesity before puberty will also have obesity during adulthood [1-3]. Liraglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA) that increases the postprandial insulin level in a glucose-dependent manner, reduces glucagon secretion and delays gastric emptying. It also reduces appetite and energy intake and thereby induces weight loss [4,5]. The FDA and EMA have approved liraglutide (3.0 mg) as an adjunct to lifestyle therapy in adults with obesity or overweight with ≥1 weight-related coexisting condition [6,7]. This study investigated the efficacy and safety of subcutaneous liraglutide (3.0 mg) as an adjunct to lifestyle therapy in pubertal adolescents with obesity.

This randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 32 sites in 5 countries (Belgium, Mexico, Russia, Sweden and the United States). It was composed of a 12-week run-in period, a 56-week treatment period (with dose escalation over a period of 4 to 8 weeks) and a 26-week follow-up period without treatment. 251 Pubertal adolescents (12 to <18 years of age) with obesity were randomized to receive liraglutide (3.0 mg, n=125) or placebo (n=126) administered subcutaneously once daily. The starting dose of the liraglutide treatment was 0.6 mg daily for 1 week and the dose was increased weekly until the maximum tolerated dose or the 3.0 mg dose was reached. Obesity was defined as a BMI corresponding to an adult value of ≥30 and in the ≥95th percentile for age and sex. Participants were required to a have a stable (self-reported) body weight and poor response to lifestyle therapy alone. Persons with type 1 diabetes were excluded, but those with T2DM were eligible to participate.

The primary endpoint was change from baseline in the BMI standard-deviation score at week 56. This score is a measure of the number of standard deviations from the population mean BMI, matched for age and sex.

Main results

Conclusion

Treatment with liraglutide plus lifestyle therapy led to a greater reduction in the BMI standard-deviation score compared to placebo plus lifestyle therapy in adolescents with obesity. Gastrointestinal adverse events, including nausea, vomiting and diarrhea, occurred more frequently in the liraglutide group compared to the placebo group, which suggests that treatment with liraglutide may not suitable for all patients.

References

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