Should sulfonylureas remain an acceptable first-Line add-On to metformin therapy in patients with type 2 diabetes? No, it's time to move on!

Diabetes Care

Volumn 38, Issue 1, 2015, Pages 170-175

  Genuth, Saul ^a  

^a CASE WESTERN RESERVE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CANAGLIFLOZIN; CHLORPROPAMIDE; DAPAGLIFLOZIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GLIBENCLAMIDE; GLIMEPIRIDE; GLIPIZIDE; GLITAZONE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; INSULIN; INSULIN GLARGINE; LIRAGLUTIDE; METFORMIN; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA DERIVATIVE; TOLBUTAMIDE; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL;

ACUTE PANCREATITIS; ADD ON THERAPY; ARTICLE; BODY WEIGHT DISORDER; CARDIOVASCULAR DISEASE; CEREBROVASCULAR ACCIDENT; DIABETES MELLITUS; DIARRHEA; DRUG CLASSIFICATION; DRUG COST; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; EDEMA; FRACTURE; GASTROINTESTINAL DISEASE; GLYCEMIC CONTROL; HEALTH INSURANCE; HEART FAILURE; HEART INFARCTION; HUMAN; HYPOGLYCEMIA; LIFESTYLE MODIFICATION; MONOTHERAPY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS CANCER; PRACTICE GUIDELINE; PRESCRIPTION; UNSPECIFIED SIDE EFFECT; VOMITING; WEIGHT GAIN; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; FEEDING BEHAVIOR; GLUCOSE BLOOD LEVEL; HYPERGLYCEMIA; METABOLISM; MOTOR ACTIVITY; RANDOMIZED CONTROLLED TRIAL (TOPIC);

BLOOD GLUCOSE; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; FOOD HABITS; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; METFORMIN; MOTOR ACTIVITY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SULFONYLUREA COMPOUNDS;

EID: 84920019040     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc14-0565     Document Type: Article

References (86)

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;35:1364-1379
2. Zimmerman BR. Sulfonylureas. Endocrinol Metab Clin North Am 1997;26:5112522
3. Turner LW, Nartey D, Stafford RS, Singh S, Alexander GC. Ambulatory treatment of type 2 diabetes in the U.S., 1997-2012. Diabetes Care 2014;37:985-992
4. DeFronzo RA, Goodman AM; The Multicenter Metformin Study Group. Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. N Engl J Med 1995;333:541-549
5. Cook MN, Girman CJ, Stein PP, Alexander CM, Holman RR. Glycemic control continues to deteriorate after sulfonylureas are added to metformin among patients with type 2 diabetes. Diabetes Care 2005;28:995-1000
6. Morgan CL, Poole CD, Evans M, Barnett AH, Jenkins-Jones S, Currie CJ. What next after metformin? A retrospective evaluation of the outcome of second-line, glucose-lowering therapies in people with type 2 diabetes. J Clin Endocrinol Metab 2012;97:4605-4612
7. Matthews DR, Charbonnel BH, Hanefeld M, Brunetti P, Schernthaner G. Long-term therapy with addition of pioglitazone to metformin compared with the addition of gliclazide tometformin in patients with type 2 diabetes: A randomized, comparative study. Diabetes Metab Res Rev 2005;21:167-174
8. Ceriello A, Johns D,WidelM, Eckland DJ,Gilmore KJ, Tan MH. Comparison of effect of pioglitazone with metformin or sulfonylurea (monotherapy and combination therapy) on postload glycemia and composite insulin sensitivity index during an oral glucose tolerance test in patients with type 2 diabetes. Diabetes Care 2005;28:266-272
9. Derosa G, Gaddi AV, Piccinni MN, et al. Differential effect of glimepiride and rosiglitazone on metabolic control of type 2 diabetic patients treated withmetformin: A randomized, double-blind, clinical trial. Diabetes Obes Metab 2006;8:197-205
10. Hamann A, Garcia-Puig J, Paul G, Donaldson J, StewartM. Comparison of fixed-dose rosiglitazone/ metformin combination therapy with sulphonylurea plus metformin in overweight individuals with type 2 diabetes inadequately controlled on metformin alone. Exp Clin Endocrinol Diabetes 2008;116:6-13
11. NauckMA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: A randomized, double-blind, non-inferiority trial. Diabetes Obes Metab 2007;9:194-205
12. Göke B, Gallwitz B, Eriksson J, Hellqvist A, Gause-Nilsson I; D1680C00001 Investigators. Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: A 52-week randomised controlled trial. Int J Clin Pract 2010;64:1619-1631
13. Matthews DR, Dejager S, Ahren B, et al. Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: Results from a 2-year study. Diabetes Obes Metab 2010;12:780-789
14. Gallwitz B, Rosenstock J, Emser A, von Eynatten M, Woerle HJ. Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA1c , 7% with no hypoglycaemia and no weight gain over 2 years. Int J Clin Pract 2013;67:317-321
15. Nauck M, Frid A, Hermansen K, et al. Longterm efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. Diabetes Obes Metab 2013;15:204-212
16. Moon JS, Ha KS, Yoon JS, Lee HW, Lee HC, Won KC; BETA study group. The effect of glargine versus glimepiride on pancreatic b-cell function in patients with type 2 diabetes uncontrolled onmetformin monotherapy: open-label, randomized, controlled study. Acta Diabetol 2014;51:277-285
17. Yki-Järvinen H, Ryysy L, Nikkilä K, Tulokas T, Vanamo R, Heikkilä M. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial. Ann Intern Med 1999;130:389-396
18. Cefalu WT, Leiter LA, Yoon KH, et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet 2013;382:941-950
19. Nauck M, del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin. Dtsch Med Wochenschr 2013;138(Suppl. 1):S6-S15 [in German]
20. Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: A report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 2013;36:1384-1395
21. Ahrén B. Avoiding hypoglycemia: A key to success for glucose-lowering therapy in type 2 diabetes. Vasc Health Risk Manag 2013;9:155-163
22. Shorr RI, Ray WA, Daugherty JR, GriffinMR. Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med 1997;157:1681-1686
23. Schopman JE, Simon AC, Hoefnagel SJ, Hoekstra JB, Scholten RJ, Holleman F. The incidence of mild and severe hypoglycaemia in patients with type 2 diabetes mellitus treated with sulfonylureas: A systematic review and metaanalysis. Diabetes Metab Res Rev 2014;30:11-22
24. Leese GP, Wang J, Broomhall J, et al.; DARTS/MEMOCollaboration. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: A population-based study of health service resource use. Diabetes Care 2003;26:1176-1180
25. Stahl M, Berger W. Higher incidence of severe hypoglycaemia leading to hospital admission in type 2 diabetic patients treated with long-acting versus short-acting sulphonylureas. Diabet Med 1999;16:586-590
26. Gangji AS, Cukierman T, Gerstein HC, Goldsmith CH, Clase CM. A systematic review and meta-analysis of hypoglycemia and cardiovascular events: A comparison of glyburide with other secretagogues and with insulin. Diabetes Care 2007;30:389-394
27. Holstein A, Plaschke A, Egberts EH. Lower incidence of severe hypoglycaemia in patients with type 2 diabetes treated with glimepiride versus glibenclamide. Diabetes Metab Res Rev 2001;17:467-473
28. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med 2011;365:2002-2012
29. Lipska KJ, Ross JS, Wang Y, et al. National trends in US hospital admissions for hyperglycemia and hypoglycemia among Medicare beneficiaries, 1999 to 2011. JAMA Intern Med 2014; 174:1116-1124
30. Williams SA, Shi L, Brenneman SK, Johnson JC, Wegner JC, Fonseca V. The burden of hypoglycemia on healthcare utilization, costs, and quality of life among type 2 diabetes mellitus patients. J Diabetes Complications 2012;26:399-406
31. Tschöpe D, Bramlage P, Binz C, et al. Antidiabetic pharmacotherapy and anamnestic hypoglycemia in a large cohort of type 2 diabetic patientsdan analysis of the DiaRegis registry. Cardiovasc Diabetol 2011;10:66
32. Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: An update including new drugs and 2-drug combinations. Ann Intern Med 2011;154:602-613
33. BunckMC,Diamant M,Cornér A, et al.One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformintreated type 2 diabetic patients: A randomized, controlled trial. Diabetes Care 2009;32:762-768
34. Kahn SE, Haffner SM, Heise MA, et al.; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006;355:2427-2443
35. Rathmann W, Kostev K, Gruenberger JB, Dworak M, BaderG,GianiG. Treatment persistence, hypoglycaemia and clinical outcomes in type 2 diabetes patients with dipeptidyl peptidase-4 inhibitors and sulphonylureas: A primary care database analysis. Diabetes Obes Metab 2013;15:55-61
36. Motola D, Piccinni C, Biagi C, et al. Cardiovascular, ocular and bone adverse reactions associated with thiazolidinediones: A disproportionality analysis of the US FDA adverse event reporting system database. Drug Saf 2012;35:315-323
37. Lincoff AM, Wolski K, Nicholls SJ, Nissen SE. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetesmellitus: Ameta-analysis of randomized trials. JAMA 2007;298:1180-1188
38. Dormandy J, Bhattacharya M, van Troostenburg de Bruyn AR; PROactive Investigators. Safety and tolerability of pioglitazone in highrisk patients with type 2 diabetes: An overview of data from PROactive. Drug Saf 2009;32:187-202
39. Aubert RE, Herrera V, Chen W, Haffner SM, Pendergrass M. Rosiglitazone and pioglitazone increase fracture risk in women and menwith type 2 diabetes. Diabetes Obes Metab 2010;12:716-721
40. Colhoun HM, Livingstone SJ, Looker HC, et al.; Scottish Diabetes Research Network Epidemiology Group. Hospitalised hip fracture risk with rosiglitazone and pioglitazone use compared with other glucose-lowering drugs. Diabetologia 2012;55:2929-2937
41. Lewis JD, Ferrara A, Peng T, et al. Risk of bladder cancer among diabetic patients treated with pioglitazone: Interimreport of a longitudinal cohort study. Diabetes Care 2011;34:916-922
42. Richard KR, Shelburne JS, Kirk JK. Tolerability of dipeptidyl peptidase-4 inhibitors: A review. Clin Ther 2011;33:1609-1629
43. Karagiannis T, Paschos P, Paletas K, Matthews DR, Tsapas A. Dipeptidyl peptidase- 4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: Systematic review and meta-analysis. BMJ 2012;344:e1369
44. Plosker GL. Sitagliptin: A review of its use in patients with type 2 diabetes mellitus. Drugs 2014;74:223-242
45. Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: A retrospective analysis of pooled clinical trial data. Postgrad Med 2013;125:58-67
46. Faillie JL, Babai S, Crépin S, et al. Pancreatitis associated with the use of GLP-1 analogs and DPP-4 inhibitors: A case/non-case study from the French Pharmacovigilance Database. Acta Diabetol 2014;51:4912497
47. Alves C, Batel-Marques F,Macedo AF. Ametaanalysis of serious adverse events reported with exenatide and liraglutide: Acute pancreatitis and cancer. Diabetes Res Clin Pract 2012;98:271-284
48. MonamiM, Dicembrini I, Nardini C, Fiordelli I, Mannucci E. Glucagon-like peptide-1 receptor agonists and pancreatitis: A meta-analysis of randomized clinical trials. Diabetes Res Clin Pract 2014;103:269-275
49. Scheen A. Gliptins (dipeptidyl peptidase-4 inhibitors) and risk of acute pancreatitis. Expert Opin Drug Saf 2013;12:545-557
50. Ryder RE. The potential risks of pancreatitis and pancreatic cancer with GLP-1-based therapies are far outweighed by the proven and potential (cardiovascular) benefits. Diabet Med 2013;30:1148-1155
51. Butler PC, Elashoff M, Elashoff R, Gale EA. A critical analysis of the clinical use of incretinbased therapies: Are the GLP-1 therapies safe? Diabetes Care 2013;36:2118-2125
52. Nauck MA. A critical analysis of the clinical use of incretin-based therapies: The benefits by far outweigh the potential risks. Diabetes Care 2013;36:2126-2132
53. Morgan CL, Jenkins-Jones S, EvansM, Barnett AH, Poole CD, Currie CJ. Weight change in people with type 2 diabetes: Secular trends and the impact of alternative antihyperglycaemic drugs. Diabetes Obes Metab 2012;14:424-432
54. Bolen S, Feldman L, Vassy J, et al. Systematic review: Comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med 2007;147:386-399
55. McEwan P, Evans M, Bergenheim K. A population model evaluating the costs and benefits associated with different oral treatment strategies in people with type 2 diabetes. Diabetes Obes Metab 2010;12:623-630
56. Bode B. Liraglutide: A review of the first once-daily GLP-1 receptor agonist. Am J Manag Care 2011;17(Suppl.):S59-S70
57. Frid A, Hermansen K, Nauck M, et al. Longterm sustained glycaemic control with liraglutide and glimepiride (both plus metformin), with added benefits of weight loss and less hypoglycaemia with liraglutide: 2-year LEAD-2 data. Diabetologia 2009;52 (Suppl. 1):S8
58. Bergenstal RM, Wysham C, Macconell L, et al.; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): A randomised trial. Lancet 2010;376:431-439
59. Guillermin AL, Lloyd A, Best JH, DeYoung MB, Samyshkin Y, Gaebler JA. Long-term costconsequence analysis of exenatide once weekly vs sitagliptin or pioglitazone for the treatment of type 2 diabetes patients in the United States. J Med Econ 2012;15:654-663
60. Gaebler JA, Soto-Campos G, Alperin P, et al. Health and economic outcomes for exenatide once weekly, insulin, and pioglitazone therapies in the treatment of type 2 diabetes: A simulation analysis. Vasc Health RiskManag 2012;8:255-264
61. St Charles M, Minshall ME, Pandya BJ, Baran RW, Tunis SL. A cost-effectiveness analysis of pioglitazone plus metformin compared with rosiglitazone plus metformin from a third-party payer perspective in the US. Curr Med Res Opin 2009;25:1343-1353
62. GoodRx, Inc. Available from www.goodrx .com. Accessed 29 April 2014
63. Meinert CL, Knatterud GL, Prout TE, Klimt CR. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. Diabetes 1970;19(Suppl.):789-830
64. Report of the Committee for the Assessment of Biometric Aspects of Controlled Trials of Hypoglycemic Agents. JAMA 1975;231:583-608
65. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-853
66. Fisman EZ, TenenbaumA, Boyko V, et al. Oral antidiabetic treatment in patients with coronary disease: Time-related increasedmortality on combined glyburide/metformin therapy over a 7.7- year follow-up. Clin Cardiol 2001;24:151-158
67. Rao AD, Kuhadiya N, Reynolds K, Fonseca VA. Is the combination of sulfonylureas and metformin associated with an increased risk of cardiovascular disease or all-cause mortality? A meta-analysis of observational studies. Diabetes Care 2008;31:1672-1678
68. Tzoulaki I, Molokhia M, Curcin V, et al. Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: Retrospective cohort study using UK general practice research database. BMJ 2009;339:b4731
69. Currie CJ, Poole CD, Evans M, Peters JR, Morgan CL. Mortality and other important diabetes-related outcomes with insulin vs other antihyperglycemic therapies in type 2 diabetes. J Clin Endocrinol Metab 2013;98:668-677
70. Roumie CL, Hung AM, Greevy RA, et al. Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: A cohort study. Ann Intern Med 2012;157:601-610
71. Simpson SH, Majumdar SR, Tsuyuki RT, Eurich DT, Johnson JA. Dose-response relation between sulfonylurea drugs and mortality in type 2 diabetes mellitus: A population-based cohort study. CMAJ 2006;174:169-174
72. Dormandy JA, Charbonnel B, Eckland DJ, et al.; PROactive Investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): A randomised controlled trial. Lancet 2005;366:1279-1289
73. Erdmann E, Dormandy JA, Charbonnel B, Massi-Benedetti M, Moules IK, Skene AM; PROactive Investigators. The effect of pioglitazone on recurrentmyocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: Results from the PROactive (PROactive 05) Study. J Am Coll Cardiol 2007;49:1772-1780
74. Wilcox R, Bousser MG, Betteridge DJ, et al.; PROactive Investigators. Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: Results from PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events 04). Stroke 2007;38:865-873
75. Erdmann E, Charbonnel B, Wilcox RG, et al.; PROactive Investigators. Pioglitazone use and heart failure in patients with type 2 diabetes and preexisting cardiovascular disease: data from the PROactive study (PROactive 08). Diabetes Care 2007;30:2773-2778
76. Langenfeld MR, Forst T, Hohberg C, et al. Pioglitazone decreases carotid intima-media thickness independently of glycemic control in patients with type 2 diabetes mellitus: Results from a controlled randomized study. Circulation 2005;111:2525-2531
77. Mazzone T, Meyer PM, Feinstein SB, et al. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: A randomized trial. JAMA 2006;296:2572-2581
78. Nissen SE, Nicholls SJ, Wolski K, et al.; PERISCOPE Investigators. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: The PERISCOPE randomized controlled trial. JAMA 2008;299:1561-1573
79. Patel D, Walitt B, Lindsay J, Wilensky RL. Role of pioglitazone in the prevention of restenosis and need for revascularization after bare-metal stent implantation: A meta-analysis. JACC Cardiovasc Interv 2011;4:353-360
80. Scirica BM, Bhatt DL, Braunwald E, et al.; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013;369:1317-1326
81. Scirica BM, Bhatt DL, Braunwald E, et al. The design and rationale of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction (SAVOR-TIMI) 53 study. Am Heart J 2011;162:8182825.e6.
82. Standl E. Saxagliptin, alogliptin, and cardiovascular outcomes. N Engl J Med 2014;370:4832484
83. Gallwitz B, Rosenstock J, Rauch T, et al. 2- year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled onmetformin: A randomised, double-blind, non-inferiority trial. Lancet 2012;380:475-483
84. Petrie JR. The cardiovascular safety of incretin-based therapies: A review of the evidence. Cardiovasc Diabetol 2013;12:130
85. Boland CL, Degeeter M, Nuzum DS, Tzefos M. Evaluating second-line treatment options for type 2 diabetes: focus on secondary effects of GLP-1 agonists and DPP-4 inhibitors. Ann Pharmacother 2013;47:490-505
86. Gaspari T, Welungoda I, Widdop RE, Simpson RW, Dear AE. The GLP-1 receptor agonist liraglutide inhibits progression of vascular disease via effects on atherogenesis, plaque stability and endothelial function in an ApoE(-/-) mouse model. Diab Vasc Dis Res 2013;10:353-360