Anti-Diabetes Therapy: Safety Considerations for Patients With Impaired Kidney Function

References

• . Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States 2011. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, 2011. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed January 23, 2014
   Google Scholar
• . Plantinga LC, Crews DC, Coresh J, ; CDC CKD Surveillance Team. Prevalence of chronic kidney disease in US adults with undiagnosed diabetes or prediabetes. Clin J Am Soc Nephrol. 2010;5(4):673–682
   PubMed Web of Science ®Google Scholar
• . Plantinga LC, Boulware LE, Coresh J, . Patient awareness of chronic kidney disease: trends and predictors. Arch Intern Med. 2008;168(20):2268–2275
   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). Diabetologia. 2012;55(6):1577–1596
   PubMed Web of Science ®Google Scholar
• . Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31–41
   PubMed Web of Science ®Google Scholar
• . Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130(6):461–470
   PubMed Web of Science ®Google Scholar
• . Levey AS, Stevens LA, Schmid CH, ; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604–612
   PubMed Web of Science ®Google Scholar
• . Delanaye P, Mariat C, Cavalier E, Maillard N, Krzesinski JM, White CA. Trimethoprim, creatinine and creatinine-based equations. Nephron Clin Pract. 2011;119(3):c187–c193; discussion c193–c194
   PubMedGoogle Scholar
• . Inker LA, Schmid CH, Tighiouart H, ; CKD-EPI Investigators. Estimating glomerular filtration rate from serum creatinine and cystatin C. N Engl J Med. 2012;367(1):20–29
   PubMed Web of Science ®Google Scholar
• . Peralta CA, Shlipak MG, Judd S, . Detection of chronic kidney disease with creatinine, cystatin C, and urine albumin-to-creatinine ratio and association with progression to end-stage renal disease and mortality. JAMA. 2011;305(15):1545–1552
   PubMed Web of Science ®Google Scholar
• . National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification and stratification. Am J Kidney Dis. 2002;39(2 suppl 1):S1–S266
   PubMed Web of Science ®Google Scholar
• . Kobayashi S, Maesato K, Moriya H, Ohtake T, Ikeda T. Insulin resistance in patients with chronic kidney disease. Am J Kidney Dis. 2005;45(2):275–280
   PubMed Web of Science ®Google Scholar
• . Chen J, Muntner P, Hamm LL, . Insulin resistance and risk of chronic kidney disease in nondiabetic US adults. J Am Soc Nephrol. 2003;14(2):469–477
   PubMed Web of Science ®Google Scholar
• . Pham H, Robinson-Cohen C, Biggs ML, . Chronic kidney disease, insulin resistance, and incident diabetes in older adults. Clin J Am Soc Nephrol. 2012;7(4):588–594
   PubMed Web of Science ®Google Scholar
• . Stumvoll M, Meyer C, Perriello G, Kreider M, Welle S, Gerich J. Human kidney and liver gluconeogenesis: evidence for organ substrate selectivity. Am J Physiol. 1998;274(5 Pt 1):E817–E826
   Google Scholar
• . Park J, Lertdumrongluk P, Molnar MZ, Kovesdy CP, Kalantar-Zadeh K. Glycemic control in diabetic dialysis patients and the burnt-out diabetes phenomenon. Curr Diab Rep. 2012;12(4):432–439
   PubMed Web of Science ®Google Scholar
• . Moen MF, Zhan M, Hsu VD, . Frequency of hypoglycemia and its significance in chronic kidney disease. Clin J Am Soc Nephrol. 2009;4(6):1121–1127
   PubMed Web of Science ®Google Scholar
• . Tangri N, Stevens LA, Griffith J, . A predictive model for progression of chronic kidney disease to kidney failure. JAMA. 2011;305(15):1553–1559
   PubMed Web of Science ®Google Scholar
• . Lipska KJ, Bailey CJ, Inzucchi SE. Use of metformin in the setting of mild-to-moderate renal insufficiency. Diabetes Care. 2011;34(6):1431–1437
   PubMed Web of Science ®Google Scholar
• . Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352(9131):837–853
   PubMed Web of Science ®Google Scholar
• . Ismail-Beigi F, Craven T, Banerji MA, ; ACCORD trial group. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet. 2010;376(9739):419–430
   PubMed Web of Science ®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
• . Duckworth W, Abraira C, Moritz T, ; VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009;360(2):129–139
   PubMed Web of Science ®Google Scholar
• . Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580–591
   PubMed Web of Science ®Google Scholar
• . Shurraw S, Hemmelgarn B, Lin M, ; Alberta Kidney Disease Network. Association between glycemic control and adverse outcomes in people with diabetes mellitus and chronic kidney disease: a population-based cohort study. Arch Intern Med. 2011;171(21):1920–1927
   PubMedGoogle Scholar
• . US Department of Health and Human Services Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance For Industry. Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing and Labeling. Washington, DC, US Department of Health and Human Services; 1998
   Google Scholar
• . Micronase [full prescribing information]. New York, NY: Pfizer Inc; 2010
   Google Scholar
• . Marbury TC, Ruckle JL, Hatorp V, . Pharmacokinetics of repaglinide in subjects with renal impairment. Clin Pharmacol Ther. 2000;67(1):7–15
   PubMed Web of Science ®Google Scholar
• . Schumacher S, Abbasi I, Weise D, . Single- and multiple-dose pharmacokinetics of repaglinide in patients with type 2 diabetes and renal impairment. Eur J Clin Pharmacol. 2001;57(2):147–152
   PubMed Web of Science ®Google Scholar
• . Devineni D, Walter YH, Smith HT, Lee JS, Prasad P, McLeod JF. Pharmacokinetics of nateglinide in renally impaired diabetic patients. J Clin Pharmacol. 2003;43(2):163–170
   PubMed Web of Science ®Google Scholar
• . Inoue T, Shibahara N, Miyagawa K, . Pharmacokinetics of nateglinide and its metabolites in subjects with type 2 diabetes mellitus and renal failure. Clin Nephrol. 2003;60(2):90–95
   PubMed Web of Science ®Google Scholar
• . Prandin [full prescribing information]. Princeton, NJ: Novo Nordisk Inc.; 2011
   Google Scholar
• . Budde K, Neumayer HH, Fritsche L, Sulowicz W, Stompôr T, Eckland D. The pharmacokinetics of pioglitazone in patients with impaired renal function. Br J Clin Pharmacol. 2003;55(4):368–374
   PubMed Web of Science ®Google Scholar
• . Onglyza [full prescribing information]. Princeton, NJ/Wilmington, DE: Bristol-Myers Squibb/AstraZeneca Pharmaceuticals LP; 2011
   Google Scholar
• . Januvia [full prescribing information]. Whitehouse Station, NJ: Merck and Co., Inc.; 2012
   Google Scholar
• . Nesina [full prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; 2013
   Google Scholar
• . Bergman AJ, Cote J, Yi B, . Effect of renal insufficiency on the pharmacokinetics of sitagliptin, a dipeptidyl peptidase-4 inhibitor. Diabetes Care. 2007;30(7):1862–1864
   PubMed Web of Science ®Google Scholar
• . Boulton DW, Li L, Frevert EU, . Influence of renal or hepatic impairment on the pharmacokinetics of saxagliptin. Clin Pharmacokinet. 2011;50(4):253–265
   PubMed Web of Science ®Google Scholar
• . Karim A, Fleck P, Hetman L, . Single-dose pharmacokinetics of the dipeptidyl peptidase-4 inhibitor alogliptin in subjects with renal impairment (Abstract 538-p). Diabetes. 2008;57( suppl 1):A160
   Web of Science ®Google Scholar
• . Graefe-Mody U, Friedrich C, Port A, . Effect of renal impairment on the pharmacokinetics of the dipeptidyl peptidase-4 inhibitor linagliptin. Diabetes Obes Metab. 2011;13(10):939–946
   PubMed Web of Science ®Google Scholar
• . Tradjenta [full prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc.; 2012
   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
• . Byetta [full prescribing information]. San Diego, CA: Amylin Pharmaceuticals, Inc.; 2011
   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
• . Victoza [full prescribing information]. Princeton, NJ: Novo Nordisk, Inc.; 2012
   Google Scholar
• . Welchol [full prescribing information]. Parsippany, NJ: Daiichi Sankyo, Inc.; 2011
   Google Scholar
• . Invokana [full prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2013
   Google Scholar
• . Kasichayanula S, Liu X, Pe Benito M, . The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013;76(3):432–444
   PubMed Web of Science ®Google Scholar
• . Hasslacher C, Multinational Repaglinide Renal Study Group. Safety and efficacy of repaglinide in type 2 diabetic patients with and without impaired renal function. Diabetes Care. 2003;26(3):886–891
   PubMed Web of Science ®Google Scholar
• . Abe M, Kikuchi F, Okada K, Kaizu K, Matsumoto K. Efficacy of pioglitazone on type 2 diabetic patients with hemodialysis. Diabetes Res Clin Pract. 2008;80(3):432–438
   PubMed Web of Science ®Google Scholar
• . Abe M, Okada K, Kikuchi F, Matsumoto K. Clinical investigation of the effects of pioglitazone on the improvement of insulin resistance and blood pressure in type 2-diabetic patients undergoing hemodialysis. Clin Nephrol. 2008;70(3):220–228
   PubMed Web of Science ®Google Scholar
• . Chan JC, Scott R, Arjona Ferreira JC, . Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency. Diabetes Obes Metab. 2008;10(7):545–555
   PubMed Web of Science ®Google Scholar
• . Arjona Ferreira JC, Corry D, Mogensen CE, . Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial. Am J Kidney Dis. 2013;61(4):579–587
   PubMed Web of Science ®Google Scholar
• . Nowicki M, Rychlik I, Haller H, Warren L, Suchower L, Gause-Nilsson I; D1680C00007 Investigators. Saxagliptin improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment. Diabetes Obes Metab. 2011;13(6):523–532
   PubMed Web of Science ®Google Scholar
• . Nowicki M, Rychlik I, Haller H, . Long-term treatment with the dipeptidyl peptidase-4 inhibitor saxagliptin in patients with type 2 diabetes mellitus and renal impairment: a randomised controlled 52-week efficacy and safety study. Int J Clin Pract. 2011;65(12):1230–1239
   PubMed Web of Science ®Google Scholar
• . Scirica BM, Bhatt DL, Braunwald E, ; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317–1326
   PubMed Web of Science ®Google Scholar
• . Fujii Y, Abe M, Higuchi T, . The dipeptidyl peptidase-4 inhibitor alogliptin improves glycemic control in type 2 diabetic patients undergoing hemodialysis. Expert Opin Pharmacother. 2013;14(3):259–267
   PubMed Web of Science ®Google Scholar
• . White WB, Pratley R, Fleck P, . Cardiovascular safety of the dipetidyl peptidase-4 inhibitor alogliptin in type 2 diabetes mellitus. Diabetes Obes Metab. 2013;15(7):668–673
   PubMed Web of Science ®Google Scholar
• . McGill JB, Sloan L, Newman J, . Long-term efficacy and safety of linagliptin in patients with type 2 diabetes and severe renal impairment: a 1-year, randomized, double-blind, placebo-controlled study. Diabetes Care. 2013;36(2):237–244
   PubMed Web of Science ®Google Scholar
• . Cooper M, Von Eynatten M, Emser A, Patel S, Woerle HJ. Efficacy and safety of linagliptin in patients with type 2 diabetes with or without renal impairment: Results from a global phase 3 program (poster). Diabetes. 2011;60( suppl 1):A293
   Web of Science ®Google Scholar
• . Davidson JA, Brett J, Falahati A, Scott D. Mild renal impairment and the efficacy and safety of liraglutide. Endocr Pract. 2011;17(3):345–355
   PubMed Web of Science ®Google Scholar
• . Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control [published online ahead of print, September 25, 2013]. Kidney Int. doi:10.1038/ki.2013.356
   Google Scholar
• . Yale JF, Bakris G, Cariou B, . Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2013;15(5):463–473
   PubMed Web of Science ®Google Scholar
• . Lavalle-Gonzalez FJ, Januszewicz A, Davidson J, . Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56(12):2582–2592
   PubMed Web of Science ®Google Scholar
• . Stenlof K, Cefalu WT, Kim KA, . Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15(4):372–382
   PubMed Web of Science ®Google Scholar
• . Glucophage and Glucophage XR [full prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; 2009
   Google Scholar
• . Glucotrol [full prescribing information]. New York, NY: Pfizer Inc.; 2010
   Google Scholar
• . Amaryl [full prescribing information]. Bridgewater, NJ: sanofi-aventis; 2009
   Google Scholar
• . Starlix [full prescribing information]. East Hanover, NJ: Novartis; 2011
   Google Scholar
• . ACTOS [full prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; 2012
   Google Scholar
• . Farxiga [full prescribing information]. Princeton, NJ and Wilmington, DE: Bristol-Myers Squibb and AstraZeneca; 2014
   Google Scholar