Liraglutide effects in a paediatric (7‐11 y) population with obesity: A randomized, double‐blind, placebo‐controlled, short‐term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
Summary: Background: Childhood obesity is a major public health concern with limited treatment options. Objective: The aim of this study was to assess safety, tolerability, pharmacokinetics, and pharmacodynamics during short‐term treatment with liraglutide in children (7‐11 y) with obesity. Methods:...
| Publicado en: | Pediatric Obesity Vol. 14; no. 5 |
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| Autores principales: | , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Wiley-Blackwell
May2019
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=135744686&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 135744686 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 20476302 ETV7 jtl: Pediatric Obesity issn: 20476302 maglogo: Y pubinfo: dt: May2019 vid: 14 iid: 5 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 135744686 135744686 135744686 10.1111/ijpo.12495 135744686 ppct: 1 formats: fmt: – @attributes: type: T – @attributes: type: C – @attributes: type: P tig: atl: Liraglutide effects in a paediatric (7‐11 y) population with obesity: A randomized, double‐blind, placebo‐controlled, short‐term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. aug: au: Mastrandrea, Lucy D. Witten, Louise Carlsson Petri, Kristin C. Hale, Paula M. Hedman, Hanna K. Riesenberg, Robert A. affil: Jacobs School of Medicine and Biomedical Sciences, Division of Pediatric Endocrinology/Diabetes, University at Buffalo, Buffalo New York sug: subj: Glucagon-Like Peptide-1 Receptor Agonists Pharmacodynamics Glucagon-Like Peptide-1 Receptor Agonists Pharmacokinetics Pediatric Obesity Drug Therapy Human Randomized Controlled Trials Random Assignment Double-Blind Studies Glucagon-Like Peptide-1 Receptor Agonists Administration and Dosage Injections, Subcutaneous Child Female Male Gastrointestinal Diseases Body Weight Drug Effects Body Mass Index Hypoglycemia Treatment Outcomes Child: 6-12 years Female Male ab: Summary: Background: Childhood obesity is a major public health concern with limited treatment options. Objective: The aim of this study was to assess safety, tolerability, pharmacokinetics, and pharmacodynamics during short‐term treatment with liraglutide in children (7‐11 y) with obesity. Methods: In this randomized, double‐blind, placebo‐controlled trial, 24 children received at least one dose of once‐daily subcutaneous liraglutide (n = 16) or placebo (n = 8) starting at 0.3 mg with weekly dose escalations up to 3.0 mg or maximum tolerated dose, and 20 children completed the trial (14 in the liraglutide group and six in the placebo group). The primary endpoint was the number of adverse events. Results: Baseline characteristics (mean ± standard deviation) included the following: age 9.9 ± 1.1 years, weight 71.5 ± 15.4 kg, and 62.5% male. Thirty‐seven adverse events were reported in nine liraglutide‐treated participants (56.3%) versus 12 events in five placebo‐treated participants (62.5%). Most adverse events were mild in severity, three were of moderate severity, and none were severe. Gastrointestinal disorders were the most frequently reported events occurring in 37.5% of liraglutide‐treated participants compared with placebo (12.5%). Six asymptomatic hypoglycaemic episodes occurred in five participants of whom four were liraglutide treated. Liraglutide exposure was consistent with dose proportionality. Body weight was the only covariate to significantly impact exposure. A significant reduction in body mass index (BMI) Z score from baseline to end of treatment (estimated treatment difference: −0.28; P = 0.0062) was observed. Conclusion: Short‐term treatment with liraglutide in children with obesity revealed a safety and tolerability profile similar to trials in adults and adolescents with obesity, with no new safety issues. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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