Language:

Exposure-response analyses of liraglutide 3.0 mg for weight management

Diabetes, obesity & metabolism, 2016-05, Vol.18 (5), p.491-499

2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. ;2016 John Wiley & Sons Ltd. ;ISSN: 1462-8902 ;EISSN: 1463-1326 ;DOI: 10.1111/dom.12639 ;PMID: 26833744

Full text available

Citations Cited by

Actions
1. Add to My Research
2. Remove from My Research
3. E-mail
4. Print
5. Permalink
6. Citation
7. EasyBib
8. EndNote
9. RefWorks
10. Delicious
11. Export RIS
12. Export BibTeX

Title:
Exposure-response analyses of liraglutide 3.0 mg for weight management
Author: Wilding, J. P. H. ; Overgaard, R. V. ; Jacobsen, L. V. ; Jensen, C. B. ; le Roux, C. W.
Subjects: Appetite Depressants - administration & dosage ; Appetite Depressants - adverse effects ; Appetite Depressants - pharmacokinetics ; Appetite Depressants - therapeutic use ; Body Mass Index ; body weight ; Cohort Studies ; Combined Modality Therapy - adverse effects ; Diabetes Mellitus, Type 2 - complications ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - therapy ; Diet, Reducing ; Dose-Response Relationship, Drug ; Double-Blind Method ; Exercise ; Female ; glucagon-like peptide-1 ; Glucagon-Like Peptide-1 Receptor - agonists ; Glucagon-Like Peptide-1 Receptor - metabolism ; Humans ; Hypoglycemic Agents - therapeutic use ; incretin ; Incretins - administration & dosage ; Incretins - adverse effects ; Incretins - pharmacokinetics ; Incretins - therapeutic use ; Liraglutide - administration & dosage ; Liraglutide - adverse effects ; Liraglutide - pharmacokinetics ; Liraglutide - therapeutic use ; Male ; Middle Aged ; Obesity - blood ; Obesity - complications ; Obesity - drug therapy ; Obesity - therapy ; Original ; Overweight - blood ; Overweight - complications ; Overweight - drug therapy ; Overweight - therapy ; pharmacokinetic ; Prediabetic State - complications ; Prediabetic State - therapy ; Sex Characteristics ; Weight Loss - drug effects
Is Part Of: Diabetes, obesity & metabolism, 2016-05, Vol.18 (5), p.491-499
Description: Aims Liraglutide 3.0 mg, an acylated GLP‐1 analogue approved for weight management, lowers body weight through decreased energy intake. We conducted exposure‐response analyses to provide important information on individual responses to given drug doses, reflecting inter‐individual variations in drug metabolism, absorption and excretion. Methods We report efficacy and safety responses across a wide range of exposure levels, using data from one phase II (liraglutide doses 1.2, 1.8, 2.4 and 3.0 mg), and two phase IIIa [SCALE Obesity and Prediabetes (3.0 mg); SCALE Diabetes (1.8; 3.0 mg)] randomized, placebo‐controlled trials (n = 4372). Results There was a clear exposure–weight loss response. Weight loss increased with greater exposure and appeared to level off at the highest exposures associated with liraglutide 3.0 mg in most individuals, but did not fully plateau in men. In individuals with overweight/obesity and comorbid type 2 diabetes, there was a clear exposure–glycated haemoglobin (HbA1c) relationship. HbA1c reduction increased with higher plasma liraglutide concentration (plateauing at ∼21 nM); however, for individuals with baseline HbA1c >8.5%, HbA1c reduction did not fully plateau. No exposure–response relationship was identified for any safety outcome, with the exception of gastrointestinal adverse events (AEs). Individuals with gallbladder AEs, acute pancreatitis or malignant/breast/benign colorectal neoplasms did not have higher liraglutide exposure compared with the overall population. Conclusions These analyses support the use of liraglutide 3.0 mg for weight management in all subgroups investigated; weight loss increased with higher drug exposure, with no concomitant deterioration in safety/tolerability besides previously known gastrointestinal side effects.
Publisher: Oxford, UK: Blackwell Publishing Ltd
Language: English
Identifier: ISSN: 1462-8902
EISSN: 1463-1326
DOI: 10.1111/dom.12639
PMID: 26833744
Source: MEDLINE
Alma/SFX Local Collection

Back to results list


INSPIRE LIBRARY - TON DUC THANG UNIVERSITY	(84-028) 37 755 057	Feedback
19 Nguyen Huu Tho St. Dist.7, HCM	thuvien@tdtu.edu.vn	Feedback

Exposure-response analyses of liraglutide 3.0 mg for weight management

2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. ;2016 John Wiley & Sons Ltd. ;ISSN: 1462-8902 ;EISSN: 1463-1326 ;DOI: 10.1111/dom.12639 ;PMID: 26833744

Searching Remote Databases, Please Wait