Type 2 Diabetes: Assessing the Relative Risks and Benefits of Glucose-lowering Medications

American Journal of Medicine

Volumn 123, Issue 4, 2010, Pages

  Bergenstal, Richard M ^a   Bailey, Clifford J ^b   Kendall, David M ^a  

^a INTERNATIONAL DIABETES CENTER   (United States)

^b ASTON UNIVERSITY   (United Kingdom)

Author keywords

Diabetes mellitus; Drug toxicity; Risk assessment; Safety; Therapeutics

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; CHLORPROPAMIDE; EXENDIN 4; GLIBENCLAMIDE; INSULIN; METFORMIN; NATEGLINIDE; PHENFORMIN; PIOGLITAZONE; REPAGLINIDE; ROSIGLITAZONE; SITAGLIPTIN; SULFONYLUREA DERIVATIVE;

ACUTE PANCREATITIS; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CONGESTIVE HEART FAILURE; FRACTURE; GLYCEMIC CONTROL; HEART INFARCTION; HUMAN; HYPERSENSITIVITY REACTION; HYPOGLYCEMIA; LACTIC ACIDOSIS; METABOLIC REGULATION; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREATITIS; PRIORITY JOURNAL; REVIEW; RHINOPHARYNGITIS; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SIDE EFFECT; SKIN EXFOLIATION; STEVENS JOHNSON SYNDROME; URINARY TRACT INFECTION; WEIGHT GAIN;

AGE DISTRIBUTION; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; RISK FACTORS;

EID: 77950123038     PISSN: 00029343     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amjmed.2009.07.017     Document Type: Review

References (86)

1. Meinert C.L., Knatterud G.L., Prout T.E., and Klimt C.R. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. Diabetes 19 Suppl (1970) 789-830
2. Nissen S.E., and Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 356 (2007) 2457-2471
3. Shah B.R., Juurlink D.N., Austin P.C., and Mamdani M.M. New use of rosiglitazone decreased following publication of a meta-analysis suggesting harm. Diabet Med 25 (2008) 871-874
4. Starner C.I., Schafer J.A., Heaton A.H., and Gleason P.P. Rosiglitazone and pioglitazone utilization from January 2007 through May 2008 associated with five risk-warning events. J Manag Care Pharm 14 (2008) 523-531
5. Barter P.J., Caulfield M., Eriksson M., et al. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med 357 (2007) 2109-2122
6. Hammad T.A., Laughren T., and Racoosin J. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry 63 (2006) 332-339
7. Mukherjee D., Nissen S.E., and Topol E.J. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 286 (2001) 954-959
8. Rossouw J.E., Anderson G.L., Prentice R.L., et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 288 (2002) 321-333
9. Cramer J.A. A systematic review of adherence with medications for diabetes. Diabetes Care 27 (2004) 1218-1224
10. Donnan P.T., MacDonald T.M., and Morris A.D. Adherence to prescribed oral hypoglycaemic medication in a population of patients with Type 2 diabetes: a retrospective cohort study. Diabet Med 19 (2002) 279-284
11. Morris A.D., Boyle D.I., McMahon A.D., et al. Adherence to insulin treatment, glycaemic control, and ketoacidosis in insulin-dependent diabetes mellitus. The DARTS/MEMO Collaboration. Diabetes Audit and Research in Tayside Scotland. Medicines Monitoring Unit. Lancet 350 9090 (1997) 1505-1510
12. Holman R.R., Paul S.K., Bethel M.A., et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 359 (2008) 1577-1589
13. Skyler J.S., Bergenstal R., Bonow R.O., et al. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care 32 (2009) 187-192
14. Centers for Disease Control and Prevention. National Diabetes Fact Sheet, 2007. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf Accessed November 19, 2008
15. American Diabetes Association. Total prevalence of diabetes & prediabetes. http://www.diabetes.org/diabetes-statistics/prevalence.jsp Accessed November 20, 2008
16. American Diabetes Association. Complications of diabetes in the United States. http://www.diabetes.org/diabetes-statistics/complications.jsp Accessed November 20, 2008
17. American Diabetes Association. Economic costs of diabetes in the U.S. in 2007. Diabetes Care 31 (2008) 596-615
18. Narayan K.M., Boyle J.P., Thompson T.J., et al. Lifetime risk for diabetes mellitus in the United States. JAMA 290 (2003) 1884-1890
19. Haffner S.M., Lehto S., Ronnemaa T., et al. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med 339 (1998) 229-234
20. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 352 9131 (1998) 837-853
21. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet 352 9131 (1998) 854-865
22. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 329 (1993) 977-986
23. Nathan D.M., Cleary P.A., Backlund J.Y., et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 353 (2005) 2643-2653
24. Stratton I.M., Adler A.I., Neil H.A., et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 321 7258 (2000) 405-412
25. Patel A., MacMahon S., Chalmers J., et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 358 (2008) 2560-2572
26. Gerstein H.C., Miller M.E., Byington R.P., et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 358 (2008) 2545-2559
27. Duckworth W., Abraira C., Moritz T., et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 360 (2009) 129-139
28. Ray K.K., Seshasai S.R., Wijesuriya S., et al. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet 373 9677 (2009) 1765-1772
29. Mannucci E., Monami M., Lamanna C., et al. Prevention of cardiovascular disease through glycemic control in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis (2009 May 7) [Epub ahead of print]
30. Diamond G.A., Bax L., and Kaul S. Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Ann Intern Med 147 (2007) 578-581
31. Hernandez A.V., Walker E., Ioannidis J.P., and Kattan M.W. Challenges in meta-analysis of randomized clinical trials for rare harmful cardiovascular events: the case of rosiglitazone. Am Heart J 156 (2008) 23-30
32. Rucker G., and Schumacher M. Simpson's paradox visualized: the example of the rosiglitazone meta-analysis. BMC Med Res Methodol 8 (2008) 34
33. Shuster J.J., Jones L.S., and Salmon D.A. Fixed vs random effects meta-analysis in rare event studies: the rosiglitazone link with myocardial infarction and cardiac death. Stat Med 26 (2007) 4375-4385
34. Singh S., Loke Y.K., and Furberg C.D. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA 298 (2007) 1189-1195
35. Dahabreh I.J. Meta-analysis of rare events: an update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone. Clin Trials 5 (2008) 116-120
36. Monami M., Marchionni N., and Mannucci E. Winners and losers at the rosiglitazone gamble A meta-analytical approach at the definition of the cardiovascular risk profile of rosiglitazone. Diabetes Res Clin Pract 82 (2008) 48-57
37. Gerrits C.M., Bhattacharya M., Manthena S., et al. Comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes. Pharmacoepidemiol Drug Saf 16 (2007) 1065-1071
38. Mannucci E., Monami M., Lamanna C., et al. Pioglitazone and cardiovascular risk. A comprehensive meta-analysis of randomized clinical trials. Diabetes Obes Metab 10 (2008) 1221-1238
39. Wilcox R., Kupfer S., and Erdmann E. Effects of pioglitazone on major adverse cardiovascular events in high-risk patients with type 2 diabetes: results from PROspective pioglitAzone Clinical Trial In macro Vascular Events (PROactive 10). Am Heart J 155 (2008) 712-717
40. Berlie H.D., Kalus J.S., and Jaber L.A. Thiazolidinediones and the risk of edema: a meta-analysis. Diabetes Res Clin Pract 76 (2007) 279-289
41. Lago R.M., Singh P.P., and Nesto R.W. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials. Lancet 370 9593 (2007) 1129-1136
42. Bailey C.J., Campbell I.W., and Chan J.C.N. Metformin: The Gold Standard (2007), John Wiley & Sons, Chichester, UK; Hoboken, NJ
43. Alvarez G.F., Tofe P.S., Krishnarajah G., et al. Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study. Diabetes Obes Metab 10 Suppl 1 (2008) 25-32
44. Cryer P.E. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II diabetes. Diabetologia 45 (2002) 937-948
45. Ridderstrale M., Gudbjornsdottir S., Eliasson B., et al. Obesity and cardiovascular risk factors in type 2 diabetes: results from the Swedish National Diabetes Register. J Intern Med 259 (2006) 314-322
46. Pischon T., Boeing H., Hoffmann K., et al. General and abdominal adiposity and risk of death in Europe. N Engl J Med 359 (2008) 2105-2120
47. Bessesen D.H. Update on obesity. J Clin Endocrinol Metab 93 (2008) 2027-2034
48. Williamson D.F., Thompson T.J., Thun M., et al. Intentional weight loss and mortality among overweight individuals with diabetes. Diabetes Care 23 (2000) 1499-1504
49. Hermansen K., and Mortensen L.S. Bodyweight changes associated with antihyperglycaemic agents in type 2 diabetes mellitus. Drug Saf 30 12 (2007) 1127-1142
50. Purnell J.Q., and Weyer C. Weight effect of current and experimental drugs for diabetes mellitus: from promotion to alleviation of obesity. Treat Endocrinol 2 (2003) 33-47
51. Dluhy R.G., and McMahon G.T. Intensive glycemic control in the ACCORD and ADVANCE trials. N Engl J Med 358 (2008) 2630-2633
52. Krentz A.J., Ferner R.E., and Bailey C.J. Comparative tolerability profiles of oral antidiabetic agents. Drug Saf 11 (1994) 223-241
53. Bailey C.J., and Nattrass M. Treatment-metformin. Baillieres Clin Endocrinol Metab 2 (1988) 455-476
54. Glucophage [package insert] (2006), Bristol-Myers Squibb Company, Princeton, NJ
55. Bailey C.J., and Turner R.C. Metformin. N Engl J Med 334 (1996) 574-579
56. Salpeter S., Greyber E., Pasternak G., and Salpeter E. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev (2002) CD002967
57. 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 147 (2007) 386-399
58. Masharani U., Karam J.H., and German M.S. Pancreatic hormones & diabetes mellitus. In: Greenspan F.S., and Gardner D.G. (Eds). Basic & Clinical Endocrinology (2004), McGraw-Hill, New York 658-746
59. Grey A. Thiazolidinedione-induced skeletal fragility-mechanisms and implications. Diabetes Obes Metab 11 4 (2009) 275-284
60. Hampton T. Diabetes drugs tied to fractures in women. JAMA 297 (2007) 1645
61. Meier C., Kraenzlin M.E., Bodmer M., et al. Use of thiazolidinediones and fracture risk. Arch Intern Med 168 (2008) 820-825
62. Loke Y.K., Singh S., and Furberg C.D. Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta-analysis. CMAJ 180 (2009) 32-39
63. Sandler R.S., Everhart J.E., Donowitz M., et al. The burden of selected digestive diseases in the United States. Gastroenterology 122 (2002) 1500-1511
64. Fagenholz P.J., Castillo C.F., Harris N.S., et al. Increasing United States hospital admissions for acute pancreatitis, 1988-2003. Ann Epidemiol 17 (2007) 491-497
65. Frey C.F., Zhou H., Harvey D.J., and White R.H. The incidence and case-fatality rates of acute biliary, alcoholic, and idiopathic pancreatitis in California, 1994-2001. Pancreas 33 (2006) 336-344
66. Trivedi C.D., and Pitchumoni C.S. Drug-induced pancreatitis: an update. J Clin Gastroenterol 39 (2005) 709-716
67. Ahmad S.R., and Swann J. Exenatide and rare adverse events. N Engl J Med 358 (2008) 1970-1971
68. Cure P., Pileggi A., and Alejandro R. Exenatide and rare adverse events. N Engl J Med 358 (2008) 1969-1970
69. Denker P.S., and Dimarco P.E. Exenatide (exendin-4)-induced pancreatitis: a case report. Diabetes Care 29 (2006) 471
70. Audia P., Feinfeld D.A., Dubrow A., and Winchester J.F. Metformin-induced lactic acidosis and acute pancreatitis precipitated by diuretic, celecoxib, and candesartan-associated acute kidney dysfunction. Clin Toxicol (Phila) 46 (2008) 164-166
71. Fimognari F.L., Corsonello A., Pastorell R., and Antonelli-Incalzi R. Metformin-induced pancreatitis: a possible adverse drug effect during acute renal failure. Diabetes Care 29 (2006) 1183
72. Mallick S. Metformin induced acute pancreatitis precipitated by renal failure. Postgrad Med J 80 942 (2004) 239-240
73. Ben M.H., Thabet H., Zaghdoudi I., and Amamou M. Metformin associated acute pancreatitis. Vet Hum Toxicol 44 (2002) 47-48
74. Dore D.D., Seeger J.D., and Arnold Chan K. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin 25 (2009) 1019-1027
75. Noel R.A., Braun D.K., Patterson R.E., and Bloomgren G. Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes: a retrospective, cohort study. Diabetes Care 32 (2009) 834-838
76. Blomgren K.B., Sundstrom A., Steineck G., and Wiholm B.E. Obesity and treatment of diabetes with glyburide may both be risk factors for acute pancreatitis. Diabetes Care 25 (2002) 298-302
77. Martinez J., Johnson C.D., Sanchez-Paya J., et al. Obesity is a definitive risk factor of severity and mortality in acute pancreatitis: an updated meta-analysis. Pancreatology 6 (2006) 206-209
78. Suazo-Barahona J., Carmona-Sanchez R., Robles-Diaz G., et al. Obesity: a risk factor for severe acute biliary and alcoholic pancreatitis. Am J Gastroenterol 93 (1998) 1324-1328
79. Januvia [package insert] (2007), Merck & Co, Inc, Whitehouse Station, NJ
80. Amori R.E., Lau J., and Pittas A.G. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA 298 (2007) 194-206
81. Green B.D., Flatt P.R., and Bailey C.J. Dipeptidyl peptidase IV (DPP IV) inhibitors: a newly emerging drug class for the treatment of type 2 diabetes. Diab Vasc Dis Res 3 (2006) 159-165
82. Ulmer A.J., Mattern T., Feller A.C., et al. CD26 antigen is a surface dipeptidyl peptidase IV (DPPIV) as characterized by monoclonal antibodies clone TII-19-4-7 and 4EL1C7. Scand J Immunol 31 (1990) 429-435
83. Fleischer B. CD26: a surface protease involved in T-cell activation. Immunol Today 15 (1994) 180-184
84. Zhu L., Tamvakopoulos C., Xie D., et al. The role of dipeptidyl peptidase IV in the cleavage of glucagon family peptides: in vivo metabolism of pituitary adenylate cyclase activating polypeptide-(1-38). J Biol Chem 278 (2003) 22418-22423
85. Foley R.N., Murray A.M., Li S., et al. Chronic kidney disease and the risk for cardiovascular disease, renal replacement, and death in the United States Medicare population, 1998 to 1999. J Am Soc Nephrol 16 (2005) 489-495
86. Trautner C., Icks A., Haastert B., et al. Incidence of blindness in relation to diabetes. A population-based study. Diabetes Care 20 (1997) 1147-1153