Risk of Hypoglycaemia with Oral Antidiabetic Agents in Patients with Type 2 Diabetes

Experimental and Clinical Endocrinology and Diabetes

Volumn 111, Issue 7, 2003, Pages 405-414

  Holstein, Andreas ^a   Egberts, E H ^a  

^a KLINIKUM LIPPE DETMOLD   (Germany)

Author keywords

Acarbose; Glibenclamide; Glimepiride; Hypoglycaemia; Meglitinides; Metformin; Sulphonylureas; Thiazolidinediones; Type 2 diabetes

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ACARBOSE; ACETYLSALICYLIC ACID; ALCOHOL; ALLOPURINOL; BIGUANIDE DERIVATIVE; CIPROFLOXACIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; FIBRIC ACID DERIVATIVE; FLUCONAZOLE; FLUVOXAMINE; GLIBENCLAMIDE; GLICLAZIDE; GLIMEPIRIDE; GLIPIZIDE; GLUCOSE; INSULIN; MEGLITINIDE; METFORMIN; MONOAMINE OXIDASE INHIBITOR; NATEGLINIDE; NONSTEROID ANTIINFLAMMATORY AGENT; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; REPAGLINIDE; ROSIGLITAZONE; SULFONAMIDE; SULFONYLUREA DERIVATIVE; UNINDEXED DRUG; WARFARIN;

CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; GERIATRIC PATIENT; GLUCOSE ABSORPTION; HUMAN; HYPOGLYCEMIA; INSULIN RESISTANCE; INSULIN SENSITIVITY; LIFE EXPECTANCY; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALNUTRITION; META ANALYSIS; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW;

CLINICAL TRIALS; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; RISK FACTORS;

EID: 0344851577     PISSN: 09477349     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2003-44287     Document Type: Review

References (101)

1. Aronoff S, Rosenblatt S, Braithwaite S, Egan J, Mathisen AL, Schneider RL. Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with Type 2 diabetes. Diabetes Care 2000; 23: 1605-1611
2. Asplund K, Wiholm BE, Lithner F. Glibenclamide-associated hypoglycaemia: a report on 57 cases. Diabetologia 1983; 24: 412-417
3. Bachmann W, Löbe A, Lacher F. Medikamentös bedingte Hypoglykämien bei Typ-II-Diabetes. Diabetes und Stoffwechsel 1995; 4: 83-89
4. Badian M, Korn A, Lehr K-H, Malerczyk V, Waldhausl W. Pharmacokinetics and pharmacodynamics of the hydroxymetabolite of glimepiride (Amaryl) after intravenous administration. Drug Metab Drug Interact 1996; 13: 69-85
5. Balant L, Zahnd G, Gorgia A, Schwarz R, Fabre J. Pharmacokinetics of glipizide in man: influence of renal insufficiency. Diabetologia 1973; 9 (Suppl): 331-338
6. Balant L, Zahnd GR, Weber F, Fabre J. Behaviour of glibenclamide on repeated administration to diabetic patients. Eur J Clin Pharmacol 1977; 11: 19-25
7. Ben-Ami H, Nagachandran P, Mendelson A, Edoute Y. Glibenclamide-induced hypoglycemic coma in 51 older patients with type 2 diabetes mellitus. JAGS 1999; 47: 631-633
8. Burge MR, Zeise TM, Sohby TA, Rassam AG, Schade DS. Low-dose ethanol predisposes elderly fasted patients with type 2 diabetes to sulfonylurea-induced low blood glucose. Diabetes Care 1999; 22: 2037-2043
9. Campbell D, Gordon B, Ings R, Beaufils M, Meyrier A, Jones R. The effects of renal disease on the pharmacokinetics of gliclazide in diabetic patients. Br J Clin Pharmacol 1985; 21: P572-573
10. Clark CM, Goldberg RB. Postgraduate medicine special report: therapeutic strategies for managing NIDDM. In: Whitehouse F, Gavin J (eds). Therapeutic Strategies for Managing NIDDM. McGraw-Hill Healthcare Information Group, 1997: 45-56
11. Corsonello A, Pedone C, Corica F, Malara A, Carosella L, Sgadari A, Mauro VN, Ceruso D, Pahor M, Carbonin P. Antihypertensive drug therapy and hypoglycemia in elderly diabetic patients treated with insulin and/or sulfonylureas. Gruppo Italiano di Farmacovigilanza nell'Anziano (GIFA). Eur J Epidemiol 1999; 15: 893-901
12. Cryer PE. Hypoglycaemia: The limiting factor in the glycaemic management of type I and type II diabetes. Diabetologia 2002; 45: 937-948
13. Damsbo P, Clauson P, Marbury TC, Windfeld K. A double-blind randomized comparison of meal-related glycemic control by repaglinide and glyburide in well-controlled type 2 diabetic patients. Diabetes Care 1999; 22: 789-794
14. Davidson MB, Peters AL. An overview of metformin in the treatment of type 2 diabetes mellitus. Am J Med 1997; 102: 99-110
15. DCCT. Epidemiology of severe hypoglycemia in the Diabetes Control and Complications Trial: Diabetes Control and Complications Trial Research Group. Am J Med 1991; 90: 450-459
16. DCCT. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New Eng J Med 1993; 329: 977-986
17. Di Cicco RA, Allen A, Carr A, Fowles S, Jorkasky DK, Freed MI. Rosiglitazone does not alter the pharmacokinetics of metformin. J Clin Pharmacol 2000; 40: 1280-1285
18. Dills D, Schneider J. Clinical evaluation of glimepiride versus glyburide in NIDDM in a double-blind comparative study. Glimepiride/Glyburide Research Group. Horm Metab Res 1996; 28: 426-429
19. Dreary IJ. Symptoms of hypoglycaemia and effects on mental performance and emotions. In: Frier B, Fisher B (eds). Hypoglycaemia in Clinical Diabetes. Chichester: Wiley, 1999: 29-54
20. Einhorn D, Rendell M, Rosenzweig J, Egan J, Mathisen A, Schneider R. Pioglitazone hydrochloride in combination with metformin in the treatment of type 2 diabetes mellitus: a randomized, placebo-controled study. Clinical Therapeutics 2000a; 22: 1395-1409
21. Einhorn D, Rendell M, Rosenzweig J, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride in combination with metformin in the treatment of type 2 diabetes mellitus: a randomized, placebo-controlled study. The Pioglitazone 027 Study Group. Clin Ther 2000b; 22: 1395-1409
22. Fisher BM, Heller S. Mortality, cardiovascular morbidity, and possible effects of hypoglycaemia on diabetic complications. In: Frier BM, Fisher BM (eds). Hypoglycaemia in Clinical Diabetes. Chichester: Wiley, 1999: 77-82
23. Fonseca V, Rosenstock J, Patwardhan R, Salzman A. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus. JAMA 2000; 283: 1695-1702
24. Frier BM, Fisher M. Impaired hypoglycaemia awareness. In: Frier BM, Fisher BM (eds). Hypoglycaemia in Clinical Diabetes. Chichester: Wiley, 1999: 111-146
25. Gudat U, Heinemann L. The effect of physical exercise on glycemia on healthy subjects following administration of glimepiride. Arzneimittelforsch 1996; 46: 606-609
26. Hanefeld M, Bouter KP, Dickinson S, Guitard C. Rapid and short-acting mealtime insulin secretion with nateglinide controls both prandial and mean glycemia. Diabetes Care 2000; 23: 202-207
27. Hansen AM, Christensen IT, Hansen JB, Carr RD, Ashcroft FM, Wahl P. Differential interactions of nateglinide and repaglinide on the human beta-cell sulphonylurea receptor 1. Diabetes 2002; 51: 2789-2795
28. Harrigan RA, Nathan MS, Beattie P. Oral agents for the treatment of type 2 diabetes mellitus: pharmacology, toxicity, and treatment. Ann Emerg Med 2001; 38: 68-78
29. Harrower AD. Comparison of efficacy, secondary failure rate, and complications of sulfonylureas. J Diabetes Complicat 1994; 8: 201-203
30. Harrower AD. Pharmacokinetics of oral antihyperglycaemic agents in patients with renal insufficiency. Clin Pharmacokinet 1996; 31: 111-119
31. Hart S, Frier B. Causes, management, and morbidity of acute hypoglycaemia in adults requiring hospital admission. QJM 1998; 91: 505-510
32. Hasslacher C, Koselj M, Gall M, Sieber J, Leyck Dieken M. Safety and efficacy of repaglinide in 281 type 2 diabetic patients with or without renal impairment. Diabetes 2001; 50 (Suppl 2): A116
33. Hatorp V, Walther KH, Christensen MS, Haug-Pihale G. Single-dose pharmacokinetics of repaglinide in subjects with chronic liver disease. J Clin Pharmacol 2000; 40: 142-152
34. Hellman B, Sehlin J, Taljedal IB. Glibenclamide is exceptional among hypoglycaemic sulphonylureas in accumulating progressively in beta-cell-rich pancreatic islets. Acta Endocrinol (Copenh) 1984; 105: 385-390
35. Hollander PA, Schwartz SL, Gatlin MR, Haas SJ, Zheng H, Foley JE, Dunning BE. Importance of early insulin secretion: comparison of nateglinide and glyburide in previously diet-treated patients with type 2 diabetes. Diabetes Care 2001; 24: 983-988
36. Holman RR, Cull CA, Turner RC. A randomized double-blind trial of acarbose in type 2 diabetes shows improved glycemic control over 3 years (UKPDS 44). Diabetes Care 1999; 22: 960-964
37. Holstein A, Plaschke A, Egberts E-H. Lower incidence of severe hypoglycaemia in patients with type 2 diabetes treated with glimepiride versus glibenclamide. Diabetes Metab Res Rev 2001; 17: 467-473
38. Holstein A, Plaschke A, Egberts E-H. Incidence and costs of severe hypoglycemia. Diabetes Care 2002; 25: 2109-2110
39. Holstein A, Plaschke A, Egberts E-H. Risk factors for prolonged and non-prolonged hypoglycemia in sulfonylurea-treated patients. Diabetes 2002a; 51 (Suppl 2): A491-492
40. Horton ES, Clinkingbeard C, Gatlin M, Foley J, Mallows S, Shen S. Nateglinide alone and in combination with metformin improves glycemic control by reducing mealtime glucose levels in type 2 diabetes. Diabetes Care 2000; 23: 1660-1665
41. Jaap AJ, Jones GC, Mc Crimmon RJ, Deary IJ, Frier BM. Perceived symptoms of hypoglycaemia in elderly type 2 diabetic patients treated with insulin. Diabet Med 1998; 15: 398-401
42. Jonsson A, Rydberg T, Sterner G, Melander A. Pharmacokinetics of glibenclamide and ist metabolites in diabetic patients with impaired renal function. Eur J Clin Pharmacol 1998; 53: 429-435
43. Karam JH, Sanz N, Salamon E, Nolte MS. Selective unresponsiveness of pancreatic B cells to acute sulfonylurea stimulation during sulfonylurea therapy in NIDDM. Diabetes 1986; 35: 1314-1320
44. Kemmer FW, Tacken M, Berger M. Mechanism of exercise-induced hypoglycemia during sulfonylurea treatment. Diabetes 1987; 36: 1178-1182
45. Kerr D, Macdonald IA, Heller SR, Tattersall RB. Alcohol causes hypoglycaemic unawareness in healthy volunteers and patients with type 1 (insulin-dependent) diabetes. Diabetologia 1990; 33: 216-221
46. Kipnes M, Krosnick A, Rendell MS, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycemic control in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study. Am J Med 2001; 111: 10-17
47. Kramer W, Muller G, Geisen K. Characterization of the molecular mode of action of the sulfonylurea, glimepiride, at adipocytes. Horm Metab Res 1996; 28: 469-487
48. Krepinsky J, Ingram AJ, Clase CM. Prolonged sulfonylurea-induced hypoglycemia in diabetic patients with end-stage renal disease. Am J Kidney Dis 2000; 35: 500-505
49. Landgraf R, Bilo HJ, Muller PG. A comparison of repaglinide and glibenclamide in the treatment of type 2 diabetic patients previously treated with sulphonylureas. Eur J Clin Pharmacol 1999, 55: 165-171
50. Landstedt-Hallin L, Adamson U, Lins PE. Oral glibenclamide suppresses glucagon secretion during insulin-induced hypoglycemia in patients with type 2 diabetes. J Clin Endocrinol Metab 1999; 84: 3140-3145
51. Lebovitz HE, Melander A. Sulfonylureas basic aspects and clinical uses. In: Alberti KGMM, DeFronzo RA, Keen H, Zimmet P (eds). International Textbook of Diabetes Mellitus. Vol. 1. Chichester: Wiley, 1992: 745-772
52. Levy CJ, Kinsley BT, Bjaj M, Simonson DC. Effect of glycemic control on glucose counterregulation during hypoglycemia in NIDDM. Diabetes Care 1998; 21: 1330-1338
53. Lindblad U, Melander A. Sulphonylurea dose-response relationships: relation to clinical practice. Diabetes Obes Metab 2000; 2: 25-31
54. Madsbad S, Kilhovd B, Lager I, Mustajoki P, Dejgaard A. Comparison between repaglinide and glipizide in type 2 diabetes mellitus: a 1-year multicentre study. Diabet Med 2001; 18: 395-401
55. Mafauzy M. Repaglinide versus glibenclamide treatment of Type 2 diabetes during Ramadan fasting. Diabetes Res Clin Pract 2002; 58: 45-53
56. Marbury T, Huang WC, Strange P, Lebovitz H. Repaglinide versus glyburide: a one-year comparison trial. Diab Res Clin Pract 1999; 43: 155-166
57. Marbury T, Ruckle JL, Hartop V, Andersen MP, Kramer Nielsen K, Huang WC, Strange P. Pharmocokinetics of repaglinide in subjects with renal impairment. Clin Pharmacol Therap 2000; 67: 7-15
58. Massi-Benedetti M, Herz M, Pfeiffer C. The effects of acute exercise on metabolic control in type 2 diabetic patients treated with glimepiride orglibenclamide. Horm Metab Res 1996; 28: 451-455
59. Miller CD, Phillips LS, Ziemer DC, Gallina DL, Cook CB, El-Kebbi IM. Hypoglycemia in patients with type 2 diabetes mellitus. Arch Intern Med 2001; 161: 1653-1659
60. Mooradian AD, Kalis J, Nugent CA. The nutritional status of ambulatory elderly type 2 diabetic patients. Age 1990; 13: 87-89
61. Morley JE. The elderly type 2 diabetic patient: special considerations. Diabet Med 1998; 15 (Suppl 4): S41-46
62. Morris AD, Boyle DI, McMahon AD, Pearce H, Evans JM, Newton RW, Jung RT, MacDonald TM. ACE inhibitor use is associated with hospitalization for severe hypoglycemia in patients with diabetes. DARTS/MEMO Collaboration. Diabetes Audit and Research in Tayside, Scotland. Medicines Monitoring Unit. Diabetes Care 1997; 20: 1363-1367
63. Mueller G, Geisen K. Characterization of the molecular mode of action of the sulfonylurea, glimepiride, at adipocytes. Horm Metab Res 1996; 28: 469-487
64. Mueller G, Hartz D, Punter J, Okonomopolos R, Kramer W. Differential interaction of glimepiride and glibenclamide with the beta cell sulphonylurea receptor. I. Binding characteristics. Biochim Biophys Acta 1994; 1191: 267-277
65. Niemi M, Brackman JT, Neuvonen M, Laitila J, Neuvonen PJ, Kivisto KT: Effects of fluconazole and fluvoxamine on the pharmacokinetics and pharmacodynamics of glimepiride. Clin Pharmacol Ther 2001; 69: 194-200
66. Niemi M, Neuvonen PJ, Kivisto KT. Effects of gemfibrozil on the pharmacokinetics and pharmacodynamics of glimepiride. Clin Pharmacol Ther 2001a; 70: 439-445
67. Niemi M, Cascorbi I, Timm R, Kroemer HK, Neuvonen PJ, Kivisto KT. Glyburide and glimepiride pharmacokinetics in subjects with different CYP2C9 genotypes. Clin Pharmacol Ther 2002; 72: 326-332
68. Nolan JJ, Jones NP, Patwardhan R, Deacon LF. Rosiglitazone taken once daily provides effective glycaemic control in patients with type 2 diabetes mellitus. Diabet Med 2000; 17: 287-294
69. Pearson JG, Antal EJ, Raehl CL, Gorsch HK, Craig WA, Albert KS, Welling PG. Pharmacokinetic disposition of 14C-glyburide in patients with varying renal function. Clin Pharmacol Ther 1986; 39: 318-324
70. Roberge RJ, Kaplan R, Frank R, Fore C. Glyburide-ciprofloxacin interaction with resistant hypoglycemia. Ann Emerg Med 2000; 36: 160-163
71. Rosenblatt S, Miskin B, Glazer NB, Prince MJ, Robertson KE: The impact of pioglitazone on glycemic control and atherogenic dyslipidemia in patients with type 2 diabetes mellitus. Coron Artery Dis 2001; 12: 413-423
72. Rosenkranz B. Pharmacokinetic basis for the safety of glimepiride in risk groups of NIDDM patients. Horm Metab Res 1996; 28: 434-439
73. Rosenkranz B, Profozic V, Metelko Z, Mrzljak V, Lange C, Malerczyk V. Pharmacokinetics and safety of glimepiride at clinically effective doses in diabetic patients with renal impairment. Diabetologia 1996; 39: 1617-1624
74. Rosenstock J, Shen SG, Gatlin MR, Foley JE. Combination therapy with nateglinide and a thiazolidinedione improves glycemic control in type 2 diabetes. Diabetes Care 2002; 25: 1529-1533
75. Rydberg T, Wahlin-Boll E, Melander A. Determination of glibenclamide and its two major metabolites in human serum and urine by column liquid chromatography. J Chromatogr 1991; 564: 223-233
76. Rydberg T, Jonsson A, Roder M, Melander A. Hypoglycemic activity of glyburide (glibenclamide) metabolites in humans. Diabetes Care 1994; 17: 1026-1030
77. Sawicki P, Düwel P, Berger M. Struktur der Notfallversorgung schwerer Hypoglykämien. Diabetes und Stoffwechsel 1994; 3: 176
78. Segel SA, Paramore DS, Cryer PE. Hypoglycemia-associated autonomic failure in advanced type 2 diabetes. Diabetes 2002; 51: 724-733
79. Shichiri M, Kishikawa H, Ohkubo Y, Wake N: Long-term results of the Kumamoto Study on optimal diabetes control in type 2 diabetic patients. Diabetes Care 2000; 23 (Suppl 2): B21-29
80. Shorr RI, Ray WA, Daugherty JR, Griffin MR. Individual sulfonylureas and serious hypoglycemia in older people. JAGS 1997; 44: 751-755
81. Sills MN, Ogu CC, Maxa J. Prolonged hypoglycemic crisis associated with glyburide. Pharmacotherapy 1997; 17: 1338-1340
82. Song DK, Ashcroft FM. Glimepiride block of cloned beta-cell, cardiac, and smooth muscle K(ATP) channels. Br J Pharmacol 2001; 133: 193-199
83. Sonnenberg G, Garg DC, Weidler D, Dixon R, Jaber L, Bowen A, DeCherney G, Mullican W, Stonesifer L. Short-term comparison of once- versus twice-daily administration of glimepiride in patients with non-insulin dependent diabetes mellitus. Ann Pharmacother 1997; 31: 671-676
84. Sonnenblick M, Shilo S. Glibenclamide induced prolonged hypoglycaemia. Age Ageing 1986; 15: 185-189
85. Spranger R, Bachmann W. Hypoglykämische Stoffwechselentgleisungen bei medikamentös behandelten Typ-II-Diabetikern. Diabetes und Stoffwechsel 1999; 8 (Suppl 1): 89
86. 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
87. Stumvoll M, Häring HU. Glitazones. Clinical effects and molecular mechanisms. Ann Med 2002; 34: 217-224
88. Sugarman JR. Hypoglycemia-associated hospitalizations in a population with a high prevalence of non-insulin-dependent diabetes mellitus. Diabetes Res Clin Pract 1991; 14: 139-147
89. Tatterhall RB. Frequency, causes, and treatment of hypoglycaemia. In: Frier B, Fisher B (eds). Hypoglycaemia in Clinical Diabetes. Chichester: Wiley, 1999: 55-89
90. Tessier D, Dawson K, Tetrault JP, Bravo G, Meneilly GS. Glibenclamide vs. gliclazide in type 2 diabetes of the elderly. Diabet Med 1994; 11: 974-980
91. ter Braak EW, Appelmann AM, van Der Tweel I, Erkelens DW, van Haeften TW. The sulfonylurea glyburide induces impairment of glucagon and growth hormone responses during mild insulin-induced hypoglycemia. Diabetes Care 2002; 25: 107-112
92. UKPDS28. A randomized trial of efficacy of early addition of metformin in sulfonylurea-treated type 2 diabetes. U. K. Prospective Diabetes Study Group. Diabetes Care 1998; 21: 87-92
93. UKPDS33. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS33). Lancet 1998; 352: 837-853
94. van Staa T, Abenhaim L, Monette J. Rates of hypoglycemia in users of sulfonylureas. J Clin Epidemiol 1997; 50: 735-741
95. Veneman T, Mitrakou A, McKan M, Cryer P, Gerich J. Induction of hypoglycaemia unawareness by asymptomatic nocturnal hypoglycaemia. Diabetes 1993; 42: 1233-1237
96. Veneman TF, Erkelens DW. Clinical review 88: Hypoglycemia unawareness in noninsulin-dependent diabetes mellitus. J Clin Endocrinol Metab 1997, 82: 1682-1684
97. Werner AL, Travaglini MT. A review of rosiglitazone in type 2 diabetes mellitus. Pharmacotherapy 2001; 21: 1082-1099
98. Whipple AO. The surgical therapy of hyperinsulinism. J Int Chir 1938; 3: 237-276
99. Wolffenbuttel BH, Landgraf R. A 1-year multicenter randomized double-blind comparison of repaglinide and glyburide for the treatment of type 2 diabetes. Dutch and German Repaglinide Study Group. Diabetes Care 1999; 22: 463-467
100. Wolffenbuttel BH, Gomist R, Squatrito S, Jones NP, Patwardhan RN. Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in type 2 diabetic patients. Diabet Med 2000; 17: 40-47
101. Yee HS, Fong NT. A review of the safety and efficacy of acarbose in diabetes mellitus. Pharmacotherapy 1996; 16: 792-805