Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis

Clinical Pharmacokinetics

Volumn 55, Issue 11, 2016, Pages 1413-1422

  Overgaard, Rune V ^a   Petri, Kristin C ^a   Jacobsen, Lisbeth V ^a   Jensen, Christine B ^a  

^a NOVO NORDISK A S   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

LIRAGLUTIDE; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE 1;

ADULT; AGE; AGED; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; DOSE CALCULATION; DOSE RESPONSE; DRUG EXPOSURE; ETHNICITY; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; INJECTION SITE; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); OBESITY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RACE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEX DIFFERENCE; WEIGHT REDUCTION; ADOLESCENT; AGONISTS; BIOLOGICAL MODEL; CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECTS; MIDDLE AGED; OVERWEIGHT; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PREDIABETIC STATE; RANDOMIZED CONTROLLED TRIAL; YOUNG ADULT;

ADOLESCENT; ADULT; AGE FACTORS; AGED; BODY WEIGHT; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GLUCAGON-LIKE PEPTIDE 1; HUMANS; HYPOGLYCEMIC AGENTS; LIRAGLUTIDE; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; OBESITY; OVERWEIGHT; PREDIABETIC STATE; SEX FACTORS; YOUNG ADULT;

EID: 84969785501     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-016-0410-7     Document Type: Article

References (45)

1. ® (liraglutide) highlights of prescribing information. Novo Nordisk Inc. 2015. Available at: http://www.novo-pi.com/saxenda.pdf. Accessed Oct 2015.
2. ® (liraglutide) summary product information. Novo Nordisk Canada Inc. 2015. Available at: http://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/Saxenda_PM_English.pdf. Accessed Aug 2015.
3. ® (liraglutide) summary product information. European Medicines Agency. 2015. Available at: http://ec.europa.eu/health/documents/community-register/2015/20150323131125/anx_131125_en.pdf. Accessed Sep 2015.
4. Federación Mexicana de Diabetes A.C. COFEPRIS approved the first treatment for chronic management of obesity in Mexico [press release], Feb 2015. Available at: http://fmdiabetes.org/aprueba-la-cofepris-primer-tratamiento-para-el-manejo-cronico-de-la-obesidad-en-mexico/. Accessed Nov 2015.
5. Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, SCALE Obesity and Prediabetes NN8022-1839 Study Group, et al. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med. 2015;373:11–22.
6. Davies M, Bode B, Kushner R, Kushner RF, Lewin A, Skjøth TV, NN8022-1922 Study Group, et al. Efficacy of liraglutide for weight loss among patients with type 2 diabetes: the SCALE diabetes randomized clinical trial. JAMA. 2015;314:687–99.
7. Secher A, Jelsing J, Baquero AF, Hecksher-Sørensen J, Cowley MA, Dalbøge LS, et al. The arcuate nucleus mediates GLP-1 receptor agonist liraglutide-dependent weight loss. J Clin Invest. 2014;124:4473–88.
8. van Can CJ, Sloth B, Jensen CB, Flint A, Blaak EE, Saris WH. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults. Int J Obes (Lond). 2014;38:784–93.
9. Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, American College of Cardiology/American Heart Association Task Force on Practice Guidelines, Obesity Society, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014;63:2985–3023.
10. Eckel RH, Kahn SE, Ferrannini E, Goldfine AB, Nathan DM, Schwartz MW, et al. Obesity and type 2 diabetes: what can be unified and what needs to be individualized? J Clin Endocrinol Metab. 2011;96:1654–63.
11. Selvin E, Parrinello CM, Sacks DB, Coresh J. Trends in prevalence and control of diabetes in the United States, 1988–1994 and 1999–2010. Ann Intern Med. 2014;160:517–25.
12. Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, Anis AH. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9:88.
13. Khaodhiar L, McCowen KC, Blackburn GL. Obesity and its comorbid conditions. Clin Cornerstone. 1999;2:17–31.
14. Collaboration Prospective Studies, Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, et al. Body-mass index and cause-specific mortality in 900,000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009;373:1083–96.
15. Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010;18:24–33.
16. Dahaghin S, Bierma-Zeinstra SM, Koes BW, Hazes JM, Pols HA. Do metabolic factors add to the effect of overweight on hand osteoarthritis? The Rotterdam Study. Ann Rheum Dis. 2007;66:916–20.
17. Phelan S, Kanaya AM, Subak LL, Hogan PE, Espeland MA, Wing RR, Action for Health in Diabetes (Look AHEAD) Research Group, et al. Prevalence and risk factors for urinary incontinence in overweight and obese diabetic women: action for health in diabetes (look ahead) study. Diabetes Care. 2009;32:1391–7.
18. Subak LL, Whitcomb E, Shen H, Saxton J, Vittinghoff E, Brown JS. Weight loss: a novel and effective treatment for urinary incontinence. J Urol. 2005;174:190–5.
19. Bray GA. Health hazards of obesity. Endocrinol Metab Clin North Am. 1996;25:907–19.
20. Wadden TA, Stunkard AJ. Social and psychological consequences of obesity. Ann Intern Med. 1985;103:1062–7.
21. Jia H, Lubetkin EI. The impact of obesity on health-related quality-of-life in the general adult US population. J Public Health (Oxf). 2005;27:156–64.
22. Rueda-Clausen CF, Padwal RS, Sharma AM. New pharmacological approaches for obesity management. Nat Rev Endocrinol. 2013;9:467–78.
23. Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U, et al. Endocrine Society. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100:342–62.
24. US FDA. Guidance for industry. Developing products for weight management. Draft Guidance. 2007. Available at: http://www.fda.gov/downloads/Drugs/Guidances/ucm071612.pdf. Accessed June 2015.
25. Hurt RT, Edakkanambeth VJ, Ebbert JO. New pharmacological treatments for the management of obesity. Curr Gastroenterol Rep. 2014;16:394.
26. Ingwersen SH, Khurana M, Madabushi R, Watson E, Jonker DM, Le Thi TD, et al. Dosing rationale for liraglutide in type 2 diabetes mellitus: a pharmacometric assessment. J Clin Pharmacol. 2012;52:1815–23.
27. Astrup A, Rossner S, Van GL, Rissanen A, Niskanen L, Al Hakim M, et al. NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009;374:1606–16.
28. Hu C, Zhang J, Zhou H. Confirmatory analysis for phase III population pharmacokinetics. Pharm Stat. 2011;10:14–26.
29. US FDA. Guidance for industry. Population pharmacokinetics. 2009. Available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM072137.pdf. Accessed June 2015.
30. EMA. Guideline on the investigation of drug interactions. 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500129606.pdf. Accessed June 2015.
31. Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, CKD-EPI Chronic Kidney Disease Epidemiology Collaboration, et al. A new equation to estimate glomerular filtration rate. CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). Ann Intern Med. 2009;150:604–12.
32. Agersø H, Jensen LB, Elbrond B, Rolan P, Zdravkovic M. The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Diabetologia. 2002;45:195–202.
33. Agersø H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur J Pharm Sci. 2003;19:141–50.
34. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. 2013. Available at: http://www.wma.net/en/30publications/10policies/b3/. Accessed June 2015.
35. International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. Good Clinical Practice. 1996. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf. Accessed June 2015.
36. Jacobsen LV, Flint A, Olsen AK, Ingwersen SH. Liraglutide in type 2 diabetes mellitus: clinical pharmacokinetics and pharmacodynamics. Clin Pharmacokinet. doi:10.1007/s40262-015-0343-6. Epub 23 Nov 2015.
37. Elbrønd B, Jakobsen G, Larsen S, Agersø H, Jensen LB, Rolan P, et al. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care. 2002;25:1398–404.
38. Jiang J, Zhang J, Jacobsen LV, Hu P. The pharmacokinetics, pharmacodynamics, and tolerability of liraglutide, a once-daily human GLP-1 analogue, after multiple subcutaneous administration in healthy Chinese male subjects. J Clin Pharmacol. 2011;51:1620–7.
39. Ingwersen SH, Petri KC, Tandon N, Yoon KH, Chen L, Vora J, et al. Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea. Diabetes Res Clin Pract. 2015;108:113–9.
40. Watson E, Jonker DM, Jacobsen LV, Ingwersen SH. Population pharmacokinetics of liraglutide, a once-daily human glucagon-like peptide-1 analog, in healthy volunteers and subjects with type 2 diabetes, and comparison to twice-daily exenatide. J Clin Pharmacol. 2010;50:886–94.
41. Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016;18(5):491–9.
42. Malm-Erjefält M, Bjørnsdottir I, Vanggaard J, Helleberg H, Larsen U, Oosterhuis B, et al. Metabolism and excretion of the once-daily human glucagon-like peptide-1 analog liraglutide in healthy male subjects and its in vitro degradation by dipeptidyl peptidase IV and neutralendopeptidase. Drug Metab Dispos. 2010;38:1944–53.
43. Pai MP. Estimating the glomerular filtration rate in obese adult patients for drug dosing. Adv Chronic Kidney Dis. 2010;17:e53–62.
44. ® (liraglutide) Summary of product characteristics. 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf. Accessed Aug 2015.
45. ® (liraglutide) Highlights of prescribing information. 2010. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf. Accessed Sep 2015.