Metformin in patientswith type 2 diabetes and kidney disease a systematic review

JAMA - Journal of the American Medical Association

Volumn 312, Issue 24, 2014, Pages 2668-2675

  Inzucchi, Silvio E ^a   Lipska, Kasia J ^a   Mayo, Helen ^b   Bailey, Clifford J ^c   McGuire, Darren K ^b  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF TEXAS AT DALLAS   (United States)

^c ASTON UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

LACTIC ACID; METFORMIN; ANTIDIABETIC AGENT;

CHRONIC KIDNEY DISEASE; CLINICAL TRIAL (TOPIC); DISEASE ASSOCIATION; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG CONTRAINDICATION; DRUG DOSE REDUCTION; DRUG SAFETY; FOLLOW UP; GLOMERULUS FILTRATION RATE; HUMAN; INCIDENCE; KIDNEY FUNCTION; LACTATE BLOOD LEVEL; LACTIC ACIDOSIS; META ANALYSIS (TOPIC); NON INSULIN DEPENDENT DIABETES MELLITUS; OBSERVATIONAL STUDY; POPULATION RESEARCH; PRACTICE GUIDELINE; PRESCRIPTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK BENEFIT ANALYSIS; SYSTEMATIC REVIEW; CHEMICALLY INDUCED; CHRONIC KIDNEY FAILURE; COMPLICATION; CONTRAINDICATIONS; DIABETES MELLITUS, TYPE 2; RISK;

ACIDOSIS, LACTIC; DIABETES MELLITUS, TYPE 2; GLOMERULAR FILTRATION RATE; HUMANS; HYPOGLYCEMIC AGENTS; METFORMIN; RENAL INSUFFICIENCY, CHRONIC; RISK;

EID: 84920025605     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2014.15298     Document Type: Review

References (89)

1. Inzucchi SE, Bergenstal RM, Buse JB, et al; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). 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.
2. Glucophage (metformin hydrochloride) [final printed labeling]. US Food and Drug Administration website. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2000/20357S019-Glucophage-prntlbl.pdf. Accessed August 2, 2014.
3. Center for Disease Control and Prevention (CDC). National Diabetes Statistics Report, 2014. CDC website. http://www.cdc.gov/diabetes/pubs/estimates14.htm. Accessed October 15, 2014.
4. Coresh J, Wei GL, McQuillan G, et al. Prevalence of high blood pressure and elevated serum creatinine level in the United States: findings from the third National Health and Nutrition Examination Survey (1988-1994). Arch Intern Med. 2001;161(9):1207-1216.
5. Salpeter SR, Greyber E, Pasternak GA, Salpeter EE. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2010; (4): CD002967.
6. Bodmer M, Meier C, Krähenbühl S, Jick SS, Meier CR. Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case-control analysis. Diabetes Care. 2008;31(11):2086-2091.
7. Cho YM, Kieffer TJ. New aspects of an old drug: metformin as a glucagon-like peptide 1 (GLP-1) enhancer and sensitiser. Diabetologia. 2011;54(2):219-222.
8. Graham GG, Punt J, Arora M, et al. Clinical pharmacokinetics of metformin. Clin Pharmacokinet. 2011;50(2):81-98.
9. Sambol NC, Chiang J, Lin ET, et al. Kidney function and age are both predictors of pharmacokinetics ofmetformin. J Clin Pharmacol. 1995;35(11):1094-1102.
10. Frid A, Sterner GN, Löndahl M, et al. Novel assay ofmetformin levels in patients with type 2 diabetes and varying levels of renal function: clinical recommendations. Diabetes Care. 2010;33(6):1291-1293.
11. Liu F, Lu JX, Tang JL, et al. Relationship of plasma creatinine and lactic acid in type 2 diabetic patients without renal dysfunction. Chin Med J (Engl). 2009;122(21):2547-2553.
12. Lin YC, Lin LY, Wang HF, Lin HD. Fasting plasma lactate concentrations in ambulatory elderly patients with type 2 diabetes receiving metformin therapy: a retrospective cross-sectional study. J Chin Med Assoc. 2010;73(12):617-622.
13. Lim VC, Sum CF, Chan ES, Yeoh LY, Lee YM, Lim SC. Lactate levels in Asian patients with type 2 diabetes mellitus onmetformin and its association with dose of metformin and renal function. Int J Clin Pract. 2007;61(11):1829-1833.
14. Duong JK, Roberts DM, Furlong TJ, et al. Metformin therapy in patients with chronic kidney disease. Diabetes Obes Metab. 2012;14(10):963-965.
15. Connolly V, Kesson CM. Metformin treatment in NIDDM patients with mild renal impairment. Postgrad Med J. 1996;72(848):352-354.
16. Mongraw-Chaffin ML, Matsushita K, Brancati FL, et al. Diabetes medication use and blood lactate level among participants with type 2 diabetes: the atherosclerosis risk in communities carotid MRI study. PLoS One. 2012;7(12):e51237.
17. Davis TM, Jackson D, Davis WA, Bruce DG, Chubb P. The relationship between metformin therapy and the fasting plasma lactate in type 2 diabetes: the Fremantle Diabetes Study. Br J Clin Pharmacol. 2001;52(2):137-144.
18. Abbasi AA, Kasmikha R, Sotingeanu DG. Metformin-induced lacticacidemia in patients with type 2 diabetes mellitus. Endocr Pract. 2000;6(6):442-446.
19. Sirtori CR, Franceschini G, Galli-Kienle M, et al. Disposition ofmetformin (N, N-dimethylbiguanide) in man. Clin Pharmacol Ther. 1978;24(6):683-693.
20. Pernicova I, Korbonits M. Metformin-mode of action and clinical implications for diabetes and cancer. Nat Rev Endocrinol. 2014;10(3):143-156.
21. Marchetti P, Benzi L, Cecchetti P, et al. Plasma biguanide levels are correlated with metabolic effects in diabetic patients. Clin Pharmacol Ther. 1987;41(4):450-454.
22. Cavallo-Perin P, Aluffi E, Estivi P, et al. The hyperlactatemic effect of biguanides: a comparison between phenformin and metformin during a 6-month treatment. Riv Eur Sci Med Farmacol. 1989;11(1):45-49.
23. Waters AK, Morgan DB, Wales JK. Blood lactate and pyruvate levels in diabetic patients treated with biguanides with and without sulphonylureas. Diabetologia. 1978;14(2):95-98.
24. Wiholm BE, Myrhed M. Metformin-associated lactic acidosis in Sweden 1977-1991. Eur J Clin Pharmacol. 1993;44(6):589-591.
25. Bergman U, Boman G, Wiholm BE. Epidemiology of adverse drug reactions to phenformin and metformin. Br Med J. 1978;2(6135):464-466.
26. Biradar V, Moran JL, Peake SL, Peter JV. Metformin-associated lactic acidosis (MALA): clinical profile and outcomes in patients admitted to the intensive care unit. Crit Care Resusc. 2010;12(3):191-195.
27. Friesecke S, Abel P, Roser M, Felix SB, Runge S. Outcome of severe lactic acidosis associated with metformin accumulation. Crit Care. 2010;14(6):R226.
28. Lalau JD, Lacroix C, De Cagny B, Fournier A. Metformin-associated lactic acidosis in diabetic patients with acute renal failure: a critical analysis of its pathogenesis and prognosis. Nephrol Dial Transplant. 1994;9(suppl 4):126-129.
29. Nguyen HL, Concepcion L. Metformin intoxication requiring dialysis. Hemodial Int. 2011;15(suppl 1):S68-S71.
30. Nyirenda MJ, Sandeep T, Grant I, Price G, McKnight JA. Severe acidosis in patients taking metformin-rapid reversal and survival despite high APACHE score. Diabet Med. 2006;23(4):432-435.
31. Scotton DW, Wierman H, Coughlan A, Walters M, Kuhn C. Assessing the appropriate use of metformin in an inpatient setting and the effectiveness of two pharmacy-based measures to improve guideline adherence. Qual Manag Health Care. 2009;18(1):71-76.
32. Seidowsky A, Nseir S, Houdret N, Fourrier F. Metformin-associated lactic acidosis: a prognostic and therapeutic study. Crit Care Med. 2009;37(7):2191-2196.
33. Strugaru AM, Botnariu G, Agoroaei L, Grigoriu IC, Butnaru E. Metformin induced lactic acidosis-particularities and course. Rev Med Chir Soc Med Nat Iasi. 2013;117(4):1035-1042.
34. Vecchio S, Giampreti A, Petrolini VM, et al. Metformin accumulation: lactic acidosis and high plasmatic metformin levels in a retrospective case series of 66 patients on chronic therapy. Clin Toxicol (Phila). 2014;52(2):129-135.
35. Lalau JD, Lacroix C, Compagnon P, et al. Role of metformin accumulation inmetformin-associated lactic acidosis. Diabetes Care. 1995;18(6):779-784.
36. Hloch O, Charvat J, Masopust J, Havlin J. Lactic acidosis in medical ICU-the role of diabetes mellitus and metformin. Neuro Endocrinol Lett. 2012;33(8):792-795.
37. Peters N, Jay N, Barraud D, et al. Metformin-associated lactic acidosis in an intensive care unit. Crit Care. 2008;12(6):R149.
38. Scale T, Harvey JN. Diabetes, metformin and lactic acidosis. Clin Endocrinol (Oxf). 2011;74(2):191-196.
39. Krzymieñ J, Karnafel W. Lactic acidosis in patients with diabetes. Pol Arch MedWewn. 2013;123(3):91-97.
40. Scott KA, Martin JH, Inder WJ. Acidosis in the hospital setting: is metformin a common precipitant? Intern Med J. 2010;40(5):342-346.
41. Wen YK. Impact of acute kidney injury on metformin-associated lactic acidosis. Int Urol Nephrol. 2009;41(4):967-972.
42. Yeung CW, Chung HY, Fong BM, et al. Metformin-associated lactic acidosis in Chinese patients with type II diabetes. Pharmacology. 2011;88(5-6):260-265.
43. Runge S, Mayerle J, Warnke C, et al. Metformin-associated lactic acidosis in patients with renal impairment solely due to drug accumulation? Diabetes Obes Metab. 2008;10(1):91-93.
44. Renda F, Mura P, Finco G, Ferrazin F, Pani L, Landoni G. Metformin-associated lactic acidosis requiring hospitalization: a national 10 year survey and a systematic literature review. Eur Rev Med Pharmacol Sci. 2013;17(suppl 1):45-49.
45. Stades AM, Heikens JT, Erkelens DW, Holleman F, Hoekstra JB. Metformin and lactic acidosis: cause or coincidence? a review of case reports. J InternMed. 2004;255(2):179-187.
46. Lalau JD, Race JM. Lactic acidosis in metformin-treated patients: prognostic value of arterial lactate levels and plasma metformin concentrations. Drug Saf. 1999;20(4):377-384.
47. Stang M, Wysowski DK, Butler-Jones D. Incidence of lactic acidosis inmetformin users. Diabetes Care. 1999;22(6):925-927.
48. Lalau JD, Race JM. Lactic acidosis inmetformin therapy: searching for a link with metformin in reports of "metformin-associated lactic acidosis." Diabetes Obes Metab. 2001;3(3):195-201.
49. Kajbaf F, Lalau JD. The criteria for metformin-associated lactic acidosis: the quality of reporting in a large pharmacovigilance database. Diabet Med. 2013;30(3):345-348.
50. Brown JB, Pedula K, Barzilay J, Herson MK, Latare P. Lactic acidosis rates in type 2 diabetes. Diabetes Care. 1998;21(10):1659-1663.
51. Van Berlo-Van De Laar IR, Vermeij CG, Doorenbos CJ. Metformin associated lactic acidosis: incidence and clinical correlation with metformin serum concentration measurements. J Clin Pharm Ther. 2011;36(3):376-382.
52. Roussel R, Travert F, Pasquet B, et al; Reduction of Atherothrombosis for Continued Health (REACH) Registry Investigators. Metformin use and mortality among patients with diabetes and atherothrombosis. Arch Intern Med. 2010;170(21):1892-1899.
53. Ekström N, Schiöler L, Svensson AM, et al. Effectiveness and safety ofmetformin in 51 675 patients with type 2 diabetes and different levels of renal function: a cohort study from the Swedish National Diabetes Register. BMJ Open. 2012;2(4):e001076.
54. Solini A, Penno G, Bonora E, et al; Renal Insufficiency and Cardiovascular Events Study Group. Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study. J AmGeriatr Soc. 2013;61(8):1253-1261.
55. Pongwecharak J, Tengmeesri N, Malanusorn N, Panthong M, Pawangkapin N. Prescribing metformin in type 2 diabetes with a contraindication: prevalence and outcome. Pharm World Sci. 2009;31(4):481-486.
56. Eppenga WL, Lalmohamed A, Geerts AF, et al. Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: a population-based cohort study. Diabetes Care. 2014;37(8):2218-2224.
57. Richy FF, Sabidó-Espin M, Guedes S, Corvino FA, Gottwald-Hostalek U. Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study. Diabetes Care. 2014;37(8):2291-2295.
58. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352(9131):854-865.
59. Selvin E, Bolen S, Yeh HC, et al. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review. Arch Intern Med. 2008;168(19):2070-2080.
60. Schramm TK, Gislason GH, Vaag A, et al. Mortality and cardiovascular risk associated with different insulin secretagogues compared with metformin in type 2 diabetes, with or without a previousmyocardial infarction: a nationwide study. Eur Heart J. 2011;32(15):1900-1908.
61. Morgan CL, Mukherjee J, Jenkins-Jones S, Holden SE, Currie CJ. Association between first-line monotherapy with sulphonylurea versus metformin and risk of all-cause mortality and cardiovascular events: a retrospective, observational study. Diabetes Obes Metab. 2014;16(10):957-962.
62. Kosmalski M, Drozdowska A, Sliwinska A, Drzewoski J. Inappropriate metformin prescribing in elderly type 2 diabetes mellitus (T2DM) patients. Adv Med Sci. 2012;57(1):65-70.
63. Vasisht KP, Chen SC, Peng Y, Bakris GL. Limitations of metformin use in patients with kidney disease: are they warranted? Diabetes Obes Metab. 2010;12(12):1079-1083.
64. Kamber N, Davis WA, Bruce DG, Davis TM. Metformin and lactic acidosis in an Australian community setting: the Fremantle Diabetes Study. Med J Aust. 2008;188(8):446-449.
65. Runge S, Alte D, Baumeister SE, Völzke H. Prevalence of risk determinants for metformin-associated lactic acidosis and metformin utilization in the study of health in Pomerania. Horm Metab Res. 2008;40(7):491-497.
66. Sweileh WM. Contraindications to metformin therapy among patients with type 2 diabetes mellitus. PharmWorld Sci. 2007;29(6):587-592.
67. Warren RE, Strachan MW, Wild S, McKnight JA. Introducing estimated glomerular filtration rate (eGFR) into clinical practice in the UK: implications for the use of metformin. Diabet Med. 2007;24(5):494-497.
68. Kennedy L, Herman WH; GOAL A1C Study Team. Renal status among patients using metformin in a primary care setting. Diabetes Care. 2005;28(4):922-924.
69. Millican S, Cottrell N, Green B. Do risk factors for lactic acidosis influence dosing of metformin? J Clin Pharm Ther. 2004;29(5):449-454.
70. Horlen C, Malone R, Bryant B, et al. Frequency of inappropriate metformin prescriptions. JAMA. 2002;287(19):2504-2505.
71. Calabrese AT, Coley KC, Da Pos SV, Swanson D, Rao RH. Evaluation of prescribing practices: risk of lactic acidosis with metformin therapy. Arch Intern Med. 2002;162(4):434-437.
72. Emslie-Smith AM, Boyle DI, Evans JM, Sullivan F, Morris AD; DARTS/MEMO Collaboration. Contraindications to metformin therapy in patients with type 2 diabetes-a population-based study of adherence to prescribing guidelines. Diabet Med. 2001;18(6):483-488.
73. Holstein A, Nahrwold D, Hinze S, Egberts EH. Contra-indications to metformin therapy are largely disregarded. Diabet Med. 1999;16(8):692-696.
74. Selby JV, Ettinger B, Swain BE, Brown JB. First 20 months' experience with use of metformin for type 2 diabetes in a large health maintenance organization. Diabetes Care. 1999;22(1):38-44.
75. Sulkin TV, Bosman D, Krentz AJ. Contraindications to metformin therapy in patients with NIDDM. Diabetes Care. 1997;20(6):925-928.
76. Bailey CJ, Day C. Diabetes therapies in renal impairment. Br J Diabetes Vasc Dis. 2012;12:167-171.
77. Pfister R, Cairns R, Erdmann E, Schneider CA. A clinical risk score for heart failure in patients with type 2 diabetes and macrovascular disease: an analysis of the PROactive study. Int J Cardiol. 2013;162(2):112-116.
78. Rosenwasser RF, Sultan S, Sutton D, Choksi R, Epstein BJ. SGLT-2 inhibitors and their potential in the treatment of diabetes. Diabetes Metab Syndr Obes. 2013;6:453-467.
79. Bailey CJ. Metformin: effects onmicro and macrovascular complications in type 2 diabetes. Cardiovasc Drugs Ther. 2008;22(3):215-224.
80. National Institute for Health and Care Excellence (NICE). NICE Guidelines: The Management of Type 2 Diabetes. NICE website. http://www.nice.org.uk/guidance/cg87/chapter/guidance. Accessed August 2, 2014.
81. European Medicines Agency (EMA). Summary Information on a Referral Opinion Following an Arbitration Pursuant to Article 11 of Council Directive 75/319/EEC as Amended, for Glucophage/Glucophage Forte/Risidon/Dianben. EMA website. http://www.ema.europa.eu/docs/en-GB/document-library/Referrals-document/Glucophage-30/WC500011044.pdf. Accesssed August 2, 2014.
82. Canadian Diabetes Association (CDA) Clinical Practice Guideline. Pharmacologic Management of Type 2 Diabetes. CDA website. http://guidelines.diabetes.ca/Browse/Chapter13. Accessed August 2, 2014.
83. National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012;60(5):850-886.
84. Lu WR, Defilippi J, Braun A. Unleash metformin: reconsideration of the contraindication in patientswith renal impairment. Ann Pharmacother. 2013;47(11):1488-1497.
85. Lipska KJ, Bailey CJ, Inzucchi SE. Use of metformin in the setting ofmild-to-moderate renal insufficiency. Diabetes Care. 2011;34(6):1431-1437.
86. Nye HJ, Herrington WG. Metformin: the safest hypoglycaemic agent in chronic kidney disease? Nephron Clin Pract. 2011;118(4):c380-c383.
87. Pilmore HL. Review: metformin: potential benefits and use in chronic kidney disease. Nephrology (Carlton). 2010;15(4):412-418.
88. US Food and Drug Administration. Request to Revise the Prescribing Label forMetformin. Regulations.govwebsite. http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2013-P-0298;fp=true;ns=true. Accesssed August 2, 2014.
89. US Food and Drug Administration. Eliminate the BoxedWarning Regarding Lactic Acidosis Associated with Metformin and Revise Precautions Section. Regulations.gov website. http://www.regulations.gov/#!docketDetail;D=FDA-2012-P-1052. Accesssed August 2, 2014.