Validity of meta-analysis in diabetes: We need to be aware of its limitations

Diabetes Care

Volumn 36, Issue 10, 2013, Pages 3361-3367

  Home, Philip D ^a  

^a NEWCASTLE UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; DAPAGLIFLOZIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLIBENCLAMIDE; HEMOGLOBIN A1C; INSULIN GLARGINE; METFORMIN; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SITAGLIPTIN; SULFONYLUREA DERIVATIVE;

ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CEREBROVASCULAR ACCIDENT; DIABETES MELLITUS; EFFECT SIZE; FRACTURE; GLYCEMIC CONTROL; HAZARD RATIO; HEART INFARCTION; HUMAN; HYPOGLYCEMIA; META ANALYSIS (TOPIC); NON INSULIN DEPENDENT DIABETES MELLITUS; OSTEOPOROSIS; RESEARCH SUBJECT; SAMPLE SIZE;

DIABETES MELLITUS; HUMANS; META-ANALYSIS AS TOPIC;

EID: 84891854108     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc12-2449     Document Type: Article

References (52)

1. Spector TD, Thompson SG. The potential and limitations of meta-analysis. J Epidemiol Community Health 1991;45:89-92
2. Thompson SG, Pocock SJ. Can metaanalyses be trusted? Lancet 1991;338: 1127-1130
3. Scottish Intercollegiate Guidelines Network. Key to evidence statements and grades of recommendations. SIGN 50: A guideline developer's handbook [Internet]. Available from http://www.sign.ac.uk/guidelines/fulltext/50/annexb. html. Accessed 16 November 2012
4. Jüni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ 2001; 323:42-46
5. US Food and Drug Administration. Guidance for industry: diabetes mellitus-evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes [PDF online]. Available from http://www.fda.gov/downloads/Drugs/ GuidanceCompliance-RegulatoryInformation/guidances/ucm071627.pdf. Accessed 1 August 2012
6. Monami M, Ahrén B, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and cardiovascular risk: a metaanalysis of randomized clinical trials. Diabetes Obes Metab 2013;15:112-120
7. Williams-Herman D, Engel SS, Round E, et al. Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord 2010;10:7
8. Davidson JA, Liebl A, Christiansen JS, et al. Risk for nocturnal hypoglycemia with biphasic insulin aspart 30 compared with biphasic human insulin 30 in adults with type 2 diabetesmellitus: ameta-analysis. Clin Ther 2009;31:1641-1651
9. Kahn SE, Zinman B, Lachin JM, et al.; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone-associated fractures in type 2 diabetes: an analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care 2008;31:845-851
10. Monami M, Dicembrini I, Antenore A, Mannucci E. Dipeptidyl peptidase-4 inhibitors and bone fractures: a meta-analysis of randomized clinical trials. Diabetes Care 2011;34:2474-2476
11. Burki TK. FDA rejects novel diabetes drug over safety fears. Lancet 2012;379:507
12. Ray KK, Seshasai SR, 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 2009; 373:1765-1772
13. Turnbull FM, Abraira C, Anderson RJ, et al.; Control Group. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia 2009;52:2288-2298
14. Mannucci E, Monami M, Lamanna C, Gori F, Marchionni N. Prevention of cardiovascular disease through glycemic control in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis 2009;19:604-612
15. Gerstein HC, Miller ME, Byington RP, et al.; Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-2559
16. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359:1577-1589
17. 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
18. 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
19. Patel A, MacMahon S, Chalmers J, et al.; ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560-2572
20. Duckworth W, Abraira C, Moritz T, et al.; VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 2009;360: 129-139
21. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327:557-560
22. Home PD, Kahn SE, Jones NP, Noronha D, Beck-Nielsen H, Viberti G; ADOPT Study Group; RECORD Steering Committee. Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials. Diabetologia 2010; 53:1838-1845
23. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356:2457-2471
24. GlaxoSmithKline. Advisory Committee Briefing Document Cardiovascular Safety of Rosiglitazone, FDA Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. King of Prussia, PA: GlaxoSmithKline, 2007. Available from http://www.fda.gov/ohrms/ dockets/ac/07/briefing/2007-4308b1-01-sponsor-backgrounder.pdf Accessed 6 January 2012
25. 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
26. Home PD, Pocock SJ, Beck-Nielsen H, et al.; RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): amulticentre, randomised, open-label trial. Lancet 2009;373: 2125-2135
27. Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA 2007;298: 1189-1195
28. Home PD, Pocock SJ, Beck-Nielsen H, et al.; RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes-an interim analysis. N Engl J Med 2007;357: 28-38
29. Dargie HJ, Hildebrandt PR, Riegger GA, et al. A randomized, placebo-controlled trial assessing the effects of rosiglitazone on echocardiographic function and cardiac status in type 2 diabetic patients with New York Heart Association Functional Class I or II Heart Failure. J Am Coll Cardiol 2007;49:1696-1704
30. DeFronzo RA, Stonehouse AH, Han J, Wintle ME. Relationship of baseline HbA1c and efficacy of current glucose-lowering therapies: a meta-analysis of randomized clinical trials. Diabet Med 2010;27:309-317
31. Deacon CF, Mannucci E, Ahrén B. Glycaemic efficacy of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors as add-on therapy to metformin in subjects with type 2 diabetes- A review and meta analysis. Diabetes Obes Metab 2012;14:762-767
32. 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
33. Jonasson JM, Ljung R, TalbäckM, Haglund B, Gudbjörnsdò ttir S, Steineck G. Insulin glargine use and short-term incidence of malignancies- A population-based followup study in Sweden. Diabetologia 2009; 52:1745-1754
34. Bethel MA, Green J, Califf RM, Holman RR. Rationale and design of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) (Abstract). Diabetes 2009;58(Suppl. 1):A639
35. 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;162:818-825, e6
36. Food and Drugs Administration. FDA briefing document: NDA 203313 and NDA 203314: Insulin degludec and insulin degludec/aspart. Endocrinologic and Metabolic Drug Advisory Committee, 2012. Available from http://www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM327015.pdf. Accessed 7 November 2012
37. Novo Nordisk. Insulin degludec and insulin degludec/insulin aspart treatment to improve glycemic control in patients with diabetes mellitus.NDAs 203314 and 203313. FDA Briefing Document, Endocrinologic and Metabolic Drug Advisory Committee, 2012. Available from http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM327017.pdf. Accessed 7 November 2012
38. Frederich R, Alexander JH, Fiedorek FT, et al. A systematic assessment of cardiovascular outcomes in the saxagliptin drug development program for type 2 diabetes. Postgrad Med 2010;122:16-27
39. Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle H-J. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol 2012;11:3
40. SmithKline Beecham: Avandia (rosiglitazone): summary of product characteristics. 2006. Welwyn Garden City, U.K.: SmithKline Beecham, 2000
41. Diamond GA, Bax L, Kaul S. Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Ann Intern Med 2007;147:578-581
42. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1-12
43. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011;64: 401-406
44. Beral V. "The practice of meta-analysis": discussion. Meta-analysis of observational studies: a case study of work in progress. J Clin Epidemiol 1995;48:165-166
45. Johnston SC. Identifying confounding by indication through blinded prospective review. Am J Epidemiol 2001;154:276-284
46. 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 previous myocardialinfarction: a nationwide study. Eur Heart J 2011;32:1900-1908
47. Bowker SL, Majumdar SR, Veugelers P, Johnson JA. Increased cancer-related mortality for patients with type 2 diabetes who use sulfonylureas or insulin. Diabetes Care 2006;29:254-258
48. Stevens RJ, Ali R, Bankhead CR, et al. Cancer outcomes and all-causemortality in adults allocated to metformin: systematic review and collaborative meta-analysis of randomised clinical trials. Diabetologia 2012;55:2593-2603
49. Lincoff AM, Wolski K, Nicholls SJ, Nissen SE. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA 2007;298:1180-1188
50. Boyle P. Insulin glargine and cancer risk: latest data. International Diabetes Federation Congress Dubai 2011, Late breaking clinical trials. Available from http://conference2.idf.org/prog.aspx. Accessed 30 August 2012
51. Boyle P, Koechlin A, Boniol M, Robertson C, Bolli GB, Rosenstock J. Updated metaanalysis of cancer risk among users of insulin glargine (Abstract). Diabetes 2012; 61(Suppl. 1):A345
52. Home P. Improved cardiovascular outcomes with DPP-4 inhibitors in diabetes - A meta-analysis (Abstract). Atherosclerosis 2012;223:533