Liraglutide pharmacokinetics and exposure-response in adolescents with obesity

被引:8
作者
Carlsson Petri, Kristin C. [1 ]
Hale, Paula M. [2 ]
Hesse, Dan [3 ]
Rathor, Naveen [4 ]
Mastrandrea, Lucy D. [5 ]
机构
[1] Novo Nordisk AS, Dept Quantitat Clin Pharmacol, Soborg, Denmark
[2] Novo Nordisk Inc, Clin Dev Med & Regulatory Affairs, Plainsboro, NJ USA
[3] Novo Nordisk AS, Dept Med & Sci Obes & Metab, Soborg, Denmark
[4] Novo Nordisk AS, Dept Global Med Affairs, Soborg, Denmark
[5] SUNY Buffalo, Jacobs Sch Med & Biomed Sci, Div Pediat Endocrinol Diabet, Buffalo, NY USA
来源
PEDIATRIC OBESITY | 2021年 / 16卷 / 10期
关键词
adolescents; clinical trial; GLP‐ 1; liraglutide; paediatric; pharmacokinetics; 3.0; MG; WEIGHT-LOSS; CHILDHOOD; OVERWEIGHT; INDIVIDUALS; POPULATION; MANAGEMENT; EFFICACY; CHILDREN; SAFETY;
D O I
10.1111/ijpo.12799
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
Background Obesity in adolescence presents a major public health challenge, often leading to obesity in adulthood with associated chronic disease. Objectives This study aimed to perform a population pharmacokinetic and exposure-response analysis of liraglutide by meta-analysis of data from trials conducted in children, adolescents and adults with obesity. Methods The population pharmacokinetic analysis investigated the effect of covariates body weight, age group (children, adolescents and adults) and sex on liraglutide exposure in adolescents compared with previous results in adults. The exposure-response relationship of liraglutide for the change from baseline in body mass index standard deviation score (BMI SDS) was evaluated in adolescents and compared to that in adults. Results Body weight was the main covariate affecting liraglutide exposure, with lower exposures at higher body weights, whereas age group was of no importance and sex was of little importance. An exposure-response relationship was demonstrated for liraglutide in both adolescents and adults as the decrease in BMI SDS from baseline increased in an exposure-dependent manner with increasing liraglutide exposure. Conclusions The population pharmacokinetic analysis supported similar liraglutide exposures in adolescents and adults; body weight was the most important covariate affecting exposure. An exposure-response relationship was established for liraglutide.
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页数:11
相关论文
共 41 条
[1]  
[Anonymous], 2015, Summary of Product Characteristics Avastin
[2]   Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study [J].
Astrup, Arne ;
Rossner, Stephan ;
Van Gaal, Luc ;
Rissanen, Aila ;
Niskanen, Leo ;
Al Hakim, Mazin ;
Madsen, Jesper ;
Rasmussen, Mads F. ;
Lean, Michael E. J. .
LANCET, 2009, 374 (9701) :1606-1616
[3]   A values-based Motivational Interviewing (MI) intervention for pediatric obesity: Study design and methods for MI Values [J].
Bean, Melanie K. ;
Mazzeo, Suzanne E. ;
Stern, Marilyn ;
Bowen, Deborah ;
Ingersoll, Karen .
CONTEMPORARY CLINICAL TRIALS, 2011, 32 (05) :667-674
[4]   Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial [J].
Blackman, A. ;
Foster, G. D. ;
Zammit, G. ;
Rosenberg, R. ;
Aronne, L. ;
Wadden, T. ;
Claudius, B. ;
Jensen, C. B. ;
Mignot, E. .
INTERNATIONAL JOURNAL OF OBESITY, 2016, 40 (08) :1310-1319
[5]  
Cox Laura, 2015, Nurs Child Young People, V27, P16, DOI 10.7748/ncyp.27.1.16.e565
[6]   Pharmacotherapy for the Treatment of Overweight and Obesity in Children, Adolescents, and Young Adults in a Large Health System in the US [J].
Czepiel, Kathryn S. ;
Perez, Numa P. ;
Reyes, Karen J. Campoverde ;
Sabharwal, Shreya ;
Stanford, Fatima Cody .
FRONTIERS IN ENDOCRINOLOGY, 2020, 11
[7]   Liraglutide in an Adolescent Population with Obesity: A Randomized, Double-Blind, Placebo-Controlled 5-Week Trial to Assess Safety, Tolerability, and Pharmacokinetics of Liraglutide in Adolescents Aged 12-17 Years [J].
Danne, Thomas ;
Biester, Torben ;
Kapitzke, Kerstin ;
Jacobsen, Sanja H. ;
Jacobsen, Lisbeth V. ;
Petri, Kristin C. Carlsson ;
Hale, Paula M. ;
Kordonouri, Olga .
JOURNAL OF PEDIATRICS, 2017, 181 :146-+
[8]   Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes The SCALE Diabetes Randomized Clinical Trial [J].
Davies, Melanie J. ;
Bergenstal, Richard ;
Bode, Bruce ;
Kushner, Robert F. ;
Lewin, Andrew ;
Skjoth, Trine Vang ;
Andreasen, Arne Haahr ;
Jensen, Christine Bjorn ;
DeFronzo, Ralph A. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2015, 314 (07) :687-699
[9]   Development of a WHO growth reference for school-aged children and adolescents [J].
de Onis, Mercedes ;
Onyango, Adelheid W. ;
Borghi, Elaine ;
Siyam, Amani ;
Nishida, Chizuru ;
Siekmann, Jonathan .
BULLETIN OF THE WORLD HEALTH ORGANIZATION, 2007, 85 (09) :660-667
[10]   The epidemiological burden of obesity in childhood: a worldwide epidemic requiring urgent action [J].
Di Cesare, Mariachiara ;
Soric, Maroje ;
Bovet, Pascal ;
Miranda, J. Jaime ;
Bhutta, Zulfiqar ;
Stevens, Gretchen A. ;
Laxmaiah, Avula ;
Kengne, Andre-Pascal ;
Bentham, James .
BMC MEDICINE, 2019, 17 (01)