Liraglutide

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Author/s:

Andrew Kraftson, Dina Griauzde

A Randomized, Controlled Trial of Liraglutide for Adolescents With Obesity

John Bayhi — Fri, 29 May 2020 18:48:44 +0000

Date Added:

May 29, 2020

Journal/Publication:

New England Journal of Medicine

Publisher:

Massachusetts Medical Society

Publication Date:

May 28, 2020

Issue:

Volume:

382

Pages:

2117-2128

URL:

A Randomized, Controlled Trial of Liraglutide for Adolescents With Obesity

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1916038

Keywords

PMID (1):

32233338

MeSH

In this 2-year RCT, liraglutide plus lifestyle counseling was twice as effective as lifestyle counseling plus placebo for helping adolescents achieve significant weight loss. James W. Mold, MD, MPH

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Background: Obesity is a chronic disease with limited treatment options in pediatric patients. Liraglutide may be useful for weight management in adolescents with obesity.

Methods: In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide (3.0 mg) or placebo subcutaneously once daily, in addition to lifestyle therapy. The primary end point was the change from baseline in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) standard-deviation score at week 56.

Results: A total of 125 participants were assigned to the liraglutide group and 126 to the placebo group. Liraglutide was superior to placebo with regard to the change from baseline in the BMI standard-deviation score at week 56 (estimated difference, -0.22; 95% confidence interval [CI], -0.37 to -0.08; P = 0.002). A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%). A greater reduction was observed with liraglutide than with placebo for BMI (estimated difference, -4.64 percentage points) and for body weight (estimated difference, -4.50 kg [for absolute change] and -5.01 percentage points [for relative change]). After discontinuation, a greater increase in the BMI standard-deviation score was observed with liraglutide than with placebo (estimated difference, 0.15; 95% CI, 0.07 to 0.23). More participants in the liraglutide group than in the placebo group had gastrointestinal adverse events (81 of 125 [64.8%] vs. 46 of 126 [36.5%]) and adverse events that led to discontinuation of the trial treatment (13 [10.4%] vs. 0). Few participants in either group had serious adverse events (3 [2.4%] vs. 5 [4.0%]). One suicide, which occurred in the liraglutide group, was assessed by the investigator as unlikely to be related to the trial treatment.

Conclusions: In adolescents with obesity, the use of liraglutide (3.0 mg) plus lifestyle therapy led to a significantly greater reduction in the BMI standard-deviation score than placebo plus lifestyle therapy. (Funded by Novo Nordisk; NN8022-4180 ClinicalTrials.gov number, NCT02918279.).

Author/s:

Kelly, AS, Auerbach, P, Barrientos-Perez, M, Gies, I, Hale, PM, Marcus, C, Mastrandrea, LD, Prabhu, N, Arslanian, S, NN8022-4180 Trial Investigators

A Randomized, Controlled Trial of Liraglutide for Adolescents With Obesity

Brian Desmarais — Fri, 29 May 2020 18:46:27 +0000

Date Added:

May 29, 2020

Journal/Publication:

New England Journal of Medicine

Publication Date:

March 31, 2020

Issue:

Volume:

382

Pages:

2117-2128

URL:

A Randomized, Controlled Trial of Liraglutide for Adolescents With Obesity

Type:

Clinical Research Results

DOI (1):

10.1056/NEJMoa1916038

MeSH

In this 2-year RCT, liraglutide plus lifestyle counselling was twice as effective as lifestyle counseling plus placebo for helping adolescents achieve significant weight loss. James W. Mold, MD, MPH

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Background: Obesity is a chronic disease with limited treatment options in pediatric patients. Liraglutide may be useful for weight management in adolescents with obesity.

Author/s:

Kelly, A.S., Auerbach, P., Barrientos-Perez, M., Gies, I., Hale, P.M., Marcus, C., Mastrandrea, L.D., Prabhu, N., Arslanian, S.