Alpha-glucosidase Inhibitors for Type 2 Diabetes Mellitus:A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

Van de Laar FA , Lucassen PLBJ

1. Radboud University Nijmegen Medical Centre, Department of General Practice, Nijmegen, The Netherlands 2. Julius Centre for Health Sciences and Primary Care, Utrecht, The Netherlands;

Corresponding author：

Keywords：

Type 2 diabetes mellitus; Alpha-glucosidase inhibitors; Systematic review

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Objectives 　To assess the effects of alpha-glucosidase inhibitors in patients with type 2 diabetes mellitus.
Method 　We searched The Cochrane Library, MEDLINE, EMBASE, Current Contents, LILACS, databases of ongoing trials, reference lists of reviews on the topic of alpha-glucosidase inhibitors and we contacted experts and manufacturers for additional trials. Date of most recent search: December 2003 (Current Contents) and April 2003 (other databases). Randomised controlled trials of at least 12 weeks duration comparing alpha-glucosidase inhibitor monotherapy in patients with type 2 diabetes with any other intervention and that included at least one of the following outcomes: mortality, morbidity, quality of life, glycemic control, lipids, insulin levels, body weight, adverse events. Two reviewers read all abstracts, assessed quality and extracted data independently. Discrepancies were resolved by consensus or by the judgement of a third reviewer. A statistician checked all extracted data entrance in the database. We attempted to contact all authors for data clarification.
Results 　We included 41 trials (8130 participants), 30 investigated acarbose, seven miglitol, one trial voglibose and three trials compared different alpha-glucosidase inhibitors. Study duration was 24 weeks in most cases and only two studies lasted amply longer than one year. We found only few data on mortality, morbidity and quality of life. Acarbose had a clear effect on glycemic control compared to placebo: glycated haemoglobin –0.77% (95% confidence interval –0.90 to –0.64), fasting blood glucose –1.1 mmol/L (95% confidence interval –1.4 to –0.9), post-load blood glucose –2.32 mmol/L (95% confidence interval –2.73 to –1.92). The effect on glycated haemoglobin by acarbose was not dose-dependent. We found a decreasing effect on post-load insulin and no clinically relevant effects on lipids or body weight. Adverse effects were mostly of gastro-intestinal origin and dose dependent. Compared to sulphonylurea, acarbose decreased fasting and post-load insulin levels by –24.8 pmol/L (95% confidence interval –43.3 to –6.3) and –133.2 pmol/L (95% confidence interval –184.5 to –81.8) respectively and acarbose caused more adverse effects.
Conclusions 　It remains unclear whether alpha-glucosidase inhibitors influence mortality or morbidity in patients with type 2 diabetes. Conversely, they have a significant effect on glycemic control and insulin levels, but no statistically significant effect on lipids and body weight. These effects are less sure when alpha-glucosidase inhibitors are used for a longer duration. Acarbose dosages higher than 50 mg TID offer no additional effect on glycated haemoglobin but more adverse effects instead. Compared to sulphonylurea, alpha-glucosidase inhibitors lower fasting and post-load insulin levels and have an inferior profile regarding glycemic control and adverse effects.

Citation： Van de Laar FA,Lucassen PLBJ,Akkermans RP,Van de Lisdonk EH,Rutten GEHM,Van Weel C. Alpha-glucosidase Inhibitors for Type 2 Diabetes Mellitus:A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2006, 06(5): 335-351. doi: Copy

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2. Rutten GEHM, Verhoeven S, Heine RJ, et al. Dutch College of General Practitioners.Guidelines on Type 2 Diabetes. Huisarts en Wetenschap, 2000; 42: 67-84.
3. Reaven GM, Lardinois CK, Greenfield MS, et al. Effect of acarbose on carbohydrate and lipid metabolism in NIDDM patients poorly controlled by sulfonylureas. Diabetes Care, 1990; 13 Suppl 3: 32-36.
4. Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet, 2002; 359(9323): 2072-2077.
5. Chiasson JL, Josse RG, Gomis R, et al. Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance: the STOP-NIDDM trial. JAMA, 2003; 290(4): 486-494.
6. Kaiser T, Sawicki PT. Acarbose for prevention of diabetes, hypertension and cardiovascular events? A critical analysis of the STOP-NIDDM data. Diabetologia, 2004; 47(3): 575-580.
7. Breuer HW. Review of acarbose therapeutic strategies in the long-term treatment and in the prevention of type 2 diabetes. International Journal of Clinical Pharmacology and Therapeutics, 2003; 41(10): 421-440.
8. Laube H. Acarbose: An Update of Its Therapeutic Use in Diabetes Treatment. Clin Drug Invest, 2002; 22: 141-156.
9. Campbell LK, Baker DE, Campbell RK. Miglitol: assessment of its role in the treatment of patients with diabetes mellitus. The Annals of Pharmacotherapy, 2000; 34(11): 1291-1301.
10. Scott LJ, Spencer CM. Miglitol: a review of its therapeutic potential in type 2 diabetes mellitus. Drugs, 2000; 59(3): 521-549.
11. Hanefeld M, Cagatay M, Petrowitsch T, et al. Acarbose reduces the risk for myocardial infarction in type 2 diabetic patients: meta-analyses of seven long-term studies. European Heart Journal, 2004; 25(1): 10-16.
12. Van de Laar FA, Lucassen PL. No evidence for a reduction of myocardial infarctions by acarbose. European Heart Journal, 2004; 25(13): 1179.
13. Coniff RF, Shapiro JA, Seaton TB, et al. Multicenter, placebo-controlled trial comparing acarbose (BAY g 5421) with placebo, tolbutamide, and tolbutamide-plus-acarbose in non-insulin-dependent diabetes mellitus. Am J Med, 1995; 98(5): 443-451.
14. Holman RR, Cull CA, Turner RC. A randomized double-blind trial of acarbose in type 2 diabetes shows improved glycemic control over 3 years (U.K. Prospective Diabetes Study 44) [see comments] [published erratum appears in Diabetes Care, 1999 Nov; 22(11): 1922]. Diabetes Care, 1999; 22(6): 960-964.
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18. National Diabetes Data Group. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes, 1979; 28(12): 1039-1057.
19. WHO Expert Committee on Diabetes Mellitus: Second report. World Health Organ Tech Rep Ser, 1980; 646: 1-80.
20. World Health Org. Diabetes Mellitus: Report of a WHO Study Group. Technical Report Series No. 727. 1985.
21. Cohen J. A coefficient of agreement for nominal scales. Educational and Psychological Measurement, 1960; 20: 37-46.
22. Begg CB, Mazumbar M. Operating characteristics of a rank correlation test for publication bias. Biometrics, 1994; 50(4): 1088-1101.
23. Egger M, Davey SG, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ, 1997; 315(7109): 629-634.
24. Hedges LV. Modeling publication selection effects in meta-analysis. Statistical Science,1992; 7: 246-255.
25. Higgins JP, Thompson SG.Quantifying heterogeneity in a meta-analysis. Statistics in Medicine, 2002; 21(11): 1539-1558.
26. Braun D, Schonherr U, Mitzkat HJ. Efficacy of acarbose monotherapy in patients with type 2 diabetes: A double-blind study conducted in general practice. Endocrinology and Metabolism, 1996; 3: 275-280.
27. Buchanan DR, Collier A, Rodrigues E, et al. Effectiveness of acarbose, an alpha-glucosidase inhibitor, in uncontrolled non-obese non-insulin dependent diabetes. Eur J Clin Pharmacol, 1988; 34(1): 51-53.
28. Calle-Pascual A, Garcia-Honduvilla J, Martin-Alvarez PJ, et al. Influence of 16-week monotherapy with acarbose on cardiovascular risk factors in obese subjects with non-insulin-dependent diabetes mellitus: a controlled, double-blind comparison study with placebo [letter]. Diabetes Metab, 1996; 22(3): 201-202.
29. Campbell I, Robertson-Mackay F, Streets E, et al. Maintenance of glycaemic control with acarbose in diet treated Type 2 diabetic patients (Abstract). Diabet Med, 1998; 15: S29-S30.
30. Chan JC, Chan KW, Ho LL, et al. An Asian multicenter clinical trial to assess the efficacy and tolerability of acarbose compared with placebo in type 2 diabetic patients previously treated with diet. Asian Acarbose Study Group. Diabetes Care, 1998; 21(7): 1058-1061.
31. Chiasson JL, Josse RG, Hunt JA, et al. The efficacy of acarbose in the treatment of patients with non-insulin-dependent diabetes mellitus. A multicenter controlled clinical trial [see comments]. Ann Intern Med, 1994; 121(11): 928-935.
32. Chiasson JL, Naditch L.The synergistic effect of miglitol plus metformin combination therapy in the treatment of type 2 diabetes. Diabetes Care, 2001; 24(6): 989-994.
33. Coniff RF, Shapiro JA, Seaton TB. Long-term efficacy and safety of acarbose in the treatment of obese subjects with non-insulin-dependent diabetes mellitus. Arch Intern Med, 1994; 154(21): 2442-2448.
34. Coniff RF, Shapiro JA, Robbins D, et al. Reduction of glycosylated haemoglobin and postprandial hyperglycemia by acarbose in patients with NIDDM. A placebo-controlled dose-comparison study. Diabetes Care, 1995; 18(6): 817-824.
35. Dedov II, Balabolkin MI, Mkrtumyan AM, et al.Glucobai therapy of diabetes mellitus. [Russian]. Problemy Endokrinologii, 1995; 41: 11-13.
36. Delgado H, Lehmann T, Bobbioni-Harsch E, et al.Acarbose improves indirectly both insulin resistance and secretion in obese type 2 diabetic patients. Diabetes Metab, 2002; 28(3): 195-200.
37. Drent ML, Tollefsen AT, van Heusden FH, et al. Dose-dependent efficacy of miglitol, an alpha-glucosidase inhibitor, in type 2 diabetic patients on diet alone: results of a 24-week double-blind placebo-controlled study. Diabetes Nutr Metab, 2002; 15(3): 152-159.
38. Fischer S, Hanefeld M, Spengler M, et al. European study on dose-response relationship of acarbose as a first-line drug in non-insulin-dependent diabetes mellitus: efficacy and safety of low and high doses. Acta Diabetol,1998; 35(1): 34-40.
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Chinese Journal of Evidence-Based Medicine

Alpha-glucosidase Inhibitors for Type 2 Diabetes Mellitus:A Systematic Review

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