Effect of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Albiglutide

References

• . US Renal Data System. USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Bethesda, MD: National Institutes of Health; 2013
   Google Scholar
• . Centers for Disease Control and Prevention. 2014 national chronic kidney disease fact sheet. http://www.cdc.gov/diabetes/pubs/factsheets/kidney.htm. Accessed March 18, 2014
   Google Scholar
• . Patel A, MacMahon S, Chalmers J, . Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358(24):2560–2572
   PubMed Web of Science ®Google Scholar
• . Herrington WG, Nye HJ, Aung T. Metformin use in chronic kidney disease: new evidence to guide dosing. QJM. 2013;106(11):1059–1061
   PubMed Web of Science ®Google Scholar
• . Martinez-Castelao A, Gorriz JL, Sola E, . About the discrepancies between consensus documents, clinical practice guidelines, and legal regulations in the treatment of type 2 diabetes. Nefrologia. 2012;32(4):419–426
   PubMed Web of Science ®Google Scholar
• . Scheen AJ. Pharmacokinetic considerations for the treatment of diabetes in patients with chronic kidney disease. Exp Opin Drug Metab Toxicol. 2013;9(5):529–550
   PubMed Web of Science ®Google Scholar
• . St Onge EL, Miller SA. Albiglutide: a new GLP-1 analog for the treatment of type 2 diabetes. Expert Opin Biol Ther. 2010;10(5):801–806
   PubMed Web of Science ®Google Scholar
• . Setji T, Feinglos M. Albiglutide: Clinical overview of a long-acting GLP-1 receptor agonist in the treatment of type 2 diabetes. Exp Rev Endocrinol Metab. 2013;8(3):229–238
   PubMedGoogle Scholar
• . Bush MA, Matthews JE, De Boever EH, . Safety, tolerability, pharmacodynamics and pharmacokinetics of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in healthy subjects. Diabetes Obes Metab. 2009;11(5):498–505
   PubMed Web of Science ®Google Scholar
• . Matthews JE, Stewart MW, De Boever EH, . Pharmacodynamics, pharmacokinetics, safety and tolerability of albiglutide, a long-acting GLP-1 mimetic, in patients with type 2 diabetes. J Clin Endocrinol Metab. 2008;93(12):4810–4817
   PubMed Web of Science ®Google Scholar
• . Nauck M, Stewart M, Perkins C, . HARMONY 2 results at week 52 primary endpoint: once-weekly albiglutide monotherapy for patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetologia. 2013;56( Suppl 1):S360–S361
   Web of Science ®Google Scholar
• . Pratley R, Stewart M, Cirkel D, Ye J, Perry C, Carr MC. Harmony 4: 52-week efficacy of albiglutide vs insulin glargine in patients with type 2 diabetes mellitus. Diabetologia. 2013;56( Suppl 1):S360–S361
   Web of Science ®Google Scholar
• . Stewart M, Yang F, Perry C, Carr MC, Home PD. 52-week efficacy of albiglutide vs placebo and vs pioglitazone in triple therapy (background metformin and glimepiride) in patients with type 2 diabetes: Harmony 5 Study. Diabetologia. 2013;56( Suppl 1):S361
   Web of Science ®Google Scholar
• . Leiter LA, Carr MC, Stewart M, Jones-Leone AR, Yang F, Handelsman Y. HARMONY 8: once weekly (QW) GLP1 agonist albiglutide (albi) vs. sitagliptin (sita) in type 2 diabetes (T2D) pts with renal impairment (RI): week 26 results. Diabetes. 2013;62( suppl 1):A17 (abstract)
   Web of Science ®Google Scholar
• . Fast DM, Kelley M, Viswanathan CT, . Workshop report and follow-up—AAPS Workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples—implications of Crystal City recommendations. AAPS J. 2009;11(2):238–241
   PubMedGoogle Scholar
• . Inzucchi SE, Bergenstal RM, Buse JB, . Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6):1364–1379
   PubMed Web of Science ®Google Scholar
• . Linnebjerg H, Kothare PA, Park S, . Effect of renal impairment on the pharmacokinetics of exenatide. Br J Clin Pharmacol. 2007;64(3):317–327
   PubMed Web of Science ®Google Scholar
• . Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M. Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Br J Clin Pharmacol. 2009;68(6):898–905
   PubMed Web of Science ®Google Scholar
• . Jones CH, Wells L, Stoves J, Farquhar F, Woodrow G. Can a reduction in extracellular fluid volume result in increased serum albumin in peritoneal dialysis patients? Am J Kidney Dis. 2002;39(4):872–875
   PubMed Web of Science ®Google Scholar
• . Chen YC, Chen HH, Yeh JC. Postdialysis serum albumin is more rational than predialysis value. Nephron. 1999;82(3):284–285
   PubMed Web of Science ®Google Scholar
• . Garber AJ. Incretin effects on beta-cell function, replication, and mass: the human perspective. Diabetes Care. 2011;34 Suppl 2:S258–S263
   PubMed Web of Science ®Google Scholar
• . Pratley RE, Nauck MA, Barnett AH, . Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014;2(4):289–297
   PubMed Web of Science ®Google Scholar
• . Rosenstock J, Reusch J, Bush M, Yang F, Stewart M. The potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care. 2009;32(10):1880–1886
   PubMed Web of Science ®Google Scholar
• . Ferrer-Garcia JC, Martinez-Chanza N, Tolosa-Torrens M, Sanchez-Juan C. Exenatide and renal failure. Diabet Med. 2010;27(6):728–729
   PubMed Web of Science ®Google Scholar
• . Johansen OE, Whitfield R. Exenatide may aggravate moderate diabetic renal impairment: a case report. Br J Clin Pharmacol. 2008;66(4):568–569
   PubMed Web of Science ®Google Scholar
• . Lopez-Ruiz A, del Peso-Gilsanz C, Meoro-Aviles A, . Acute renal failure when exenatide is co-administered with diuretics and angiotensin II blockers. Pharm World Sci. 2010;32(5):559–561
   PubMedGoogle Scholar
• . Weise WJ, Sivanandy MS, Block CA, Comi RJ. Exenatide-associated ischemic renal failure. Diabetes Care. 2009;32(2):e22–e23
   Google Scholar
• . Kaakeh Y, Kanjee S, Boone K, Sutton J. Liraglutide-induced acute kidney injury. Pharmacotherapy. 2012;32(1):e7–11
   PubMed Web of Science ®Google Scholar
• . Narayana SK, Talab SK, Elrishi MA. Liraglutide-induced acute kidney injury. Pract Diabetes. 2012;29(9):380–382
   Google Scholar
• . Victoza (liraglutide [rDNA origin] injection) [prescribing information]. Princeton, NJ: Novo Nordisk Inc.; 2013
   Google Scholar
• . Byetta (exenatide) injection [prescribing information]. San Diego, CA: Amylin Pharmaceuticals, Inc.; 2013
   Google Scholar