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Post-Marketing Surveillance of Acarbose Treatment in Patients with Type 2 Diabetes Mellitus and Subjects with Impaired Glucose Tolerance in China

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Abstract

Objective: This open, prospective, non-interventional, non-randomised, multicentre postmarketing surveillance study was conducted over a mean period of 13.9 weeks to assess the efficacy, safety and acceptance of acarbose in Chinese patients with type 2 diabetes mellitus and subjects with impaired glucose tolerance (IGT) in routine clinical practice. Subjects with IGT were included in analyses because acarbose has been approved for treatment of this condition since 2002.

Patients and methods: A total of 2550 study participants were enrolled by 133 physicians throughout China. Efficacy parameters were the changes from initial visit to the end of study in glycosylated haemoglobin (HbA1c), fasting blood glucose (FBG), postprandial BG and bodyweight.

Results: The majority of study participants (74.7%) were newly diagnosed. Most (77.0%) were administered acarbose 50mg three times daily (the recommended standard dose in China) throughout the study and more than half (51.7%) received concomitant antihyperglycaemic treatment. Acarbose treatment reduced HbA1c by 1.4% to 6.7%, FBG by 38.5 mg/dL to 116.4 mg/dL, 2-hour postprandial BG by 92.2 mg/dL to 149.0 mg/dL and bodyweight by 0.4kg to 67.5kg. Subgroup analyses for type 2 diabetes and IGT populations were also conducted. In diabetic patients, HbA1c was reduced by 1.4%, FBG by 42.1 mg/dL and 2-hour postprandial BG by 98.9 mg/dL. Marked reductions were also achieved in the IGT population (0.9% for HbA1c, 11.8 mg/dL for FBG and 42.9 mg/dL for 2-hour postprandial BG) despite lower baseline glucose levels in this group than in patients with type 2 diabetes. Bodyweight slightly increased in the IGT population. Only 12 acarbose-related adverse events, none of which was serious, were reported. The attending physicians assessed treatment efficacy as ‘good’ or ‘very good’ for 92.4%, tolerability as ‘good’ or ‘very good’ for 91.1%, and patient acceptance as ‘good’ or ‘very good’ for 89.8% of all study participants.

Conclusion: Acarbose was efficacious, safe and well accepted by Chinese patients with type 2 diabetes and subjects with IGT under day-to-day treatment conditions, both as monotherapy and in combination with other antihyperglycaemic medication.

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References

  1. Zimmet P, Alberti KGMM, Shaw J. Global and societal implications of the diabetes epidemic. Nature 2001; 414: 782–7

    Article  PubMed  CAS  Google Scholar 

  2. Harris MI. Impaired glucose tolerance: prevalence and conversion to NIDDM. Diabetic Med 1996; 13: S9–S11

    Article  PubMed  CAS  Google Scholar 

  3. Edelstein SL, Knowler WC, Bain RP, et al. Predictors of progression from impaired glucose tolerance to NIDDM: an analysis of six prospective studies. Diabetes 1997; 46: 701–10

    Article  PubMed  CAS  Google Scholar 

  4. Tominaga M, Eguchi H, Manaka H, et al. Impaired glucose tolerance is a risk factor for cardiovascular disease, but not impaired fasting glucose: the Funagata Diabetes Study. Diabetes Care 1999; 22: 920–4

    Article  PubMed  CAS  Google Scholar 

  5. DECODE Study Group. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med 2001; 161: 397–405

    Article  Google Scholar 

  6. Isomaa B, Almgren P, Tuomi T, et al. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care 2001; 24: 683–9

    Article  PubMed  CAS  Google Scholar 

  7. Coutinho M, Gerstein HC, Wang Y, et al. The relationship between glucose and incident cardiovascular events: a metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. Diabetes Care 1999; 22: 233–40

    Article  PubMed  CAS  Google Scholar 

  8. Qiao Q, Jousilahti P, Eriksson J, et al. Predictive properties of impaired glucose tolerance for cardiovascular risk are not explained by the development of overt diabetes during followup. Diabetes Care 2003; 26: 2910–4

    Article  PubMed  Google Scholar 

  9. International Diabetes Federation. The IDF consensus worldwide definition of the metabolic syndrome. Berlin, Germany 2005 [online]. Available from URL: http://www.idf.org/webdata/docs/IDF_Metasyndrome_definition.pdf [Accessed 2006 Mar 27]

  10. International Diabetes Federation. Diabetes atlas [online]. Available from URL: http://www.eatlas.idf.org [Accessed 2006 May 18]

  11. International Diabetes Federation. Fact sheet: impaired glucose tolerance (IGT) [online]. Available from URL: http://ww-w.idf.org [Accessed 2006 May 18]

  12. Wild S, Roglic G, Green A, et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004; 27: 1047–53

    Article  PubMed  Google Scholar 

  13. Wang K, Li T, Xiang H. Study on the epidemiological characteristics of diabetes mellitus and IGT in China [English abstract]. Chin J Epidemiol 1998; 19: 282–5

    CAS  Google Scholar 

  14. Gu D, Reynolds K, Duan X, et al. Prevalence of diabetes and impaired fasting glucose in the Chinese adult population: International Collaborative Study of Cardiovascular Disease in Asia (InterASIA). Diabetologia 2003; 46: 1190–8

    Article  PubMed  CAS  Google Scholar 

  15. Pan X-R, Li G-W, Hu Y-H, et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care 1997; 20: 537–44

    Article  PubMed  CAS  Google Scholar 

  16. Pan X-R, Hu Y-H, Li G-W, et al. Impaired glucose tolerance and its relationship to ECG-indicated coronary heart disease and risk factors among Chinese. Da Qing IGT and Diabetes Study. Diabetes Care 1993; 16: 150–6

    Article  PubMed  CAS  Google Scholar 

  17. Bischoff H. The mechanism of α-glucosidase inhibition in the management of diabetes. Clin Invest Med 1995; 18: 303–11

    PubMed  CAS  Google Scholar 

  18. Chiasson J–L, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet 2002; 359: 2072–7

    Article  PubMed  CAS  Google Scholar 

  19. Yang W, Lin L, Qi J, et al. The preventive effect of acarbose and metformin on the progression to diabetes mellitus in the IGT population: a 3-year multicenter prospective study [English abstract]. Chin J Endocrinol Metab 2001; 17: 131–6

    CAS  Google Scholar 

  20. Pan C–Y, Gao Y, Chen J–W, et al. Efficacy of acarbose in Chinese subjects with impaired glucose tolerance. Diabetes Res Clin Pract 2003; 61: 183–90

    Article  PubMed  CAS  Google Scholar 

  21. Chiasson J–L, 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: 486–94

    Article  PubMed  CAS  Google Scholar 

  22. Breuer H-WM. Review of acarbose therapeutic strategies in the long-term treatment and in the prevention of type 2 diabetes. Int J Clin Pharmacol Ther 2003; 41: 421–40

    PubMed  CAS  Google Scholar 

  23. Lam KSL, Tiu SC, Tsang MW, et al. Acarbose in NIDDM patients with poor control on conventional oral agents: a 24-week placebo-controlled study. Diabetes Care 1998; 21: 1154–8

    Article  PubMed  CAS  Google Scholar 

  24. Chan JCN, Chan K-WA, Ho LLT, 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. Diabetes Care 1998; 21: 1058–61

    Article  PubMed  CAS  Google Scholar 

  25. Hwu C–M, Ho L–T, Fuh MMT, et al. Acarbose improves glycemic control in insulin-treated Asian type 2 diabetic patients: results from a multinational, placebo-controlled study. Diabetes Res Clin Pract 2003; 60: 111–8

    Article  PubMed  CAS  Google Scholar 

  26. Lin BJ, Wu H–P, Huang HS, et al. Efficacy and tolerability of acarbose in Asian patients with type 2 diabetes inadequately controlled with diet and sulfonylureas. J Diabetes Complications 2003; 17: 179–85

    Article  PubMed  CAS  Google Scholar 

  27. Sumual AR, Pandelaki K, Rotty LAW. Acarbose/metformin combination versus metformin alone in Indonesian patients with type 2 diabetes. JAFES 2003; 21: 24–31

    Google Scholar 

  28. Inoue S, Zimmet P (editors). The Asia-Pacific perspective: redefining obesity and its treatment. World Health Organization Western Pacific Region/International Obesity Task Force/ International Association for the Study of Obesity. Hong Kong, China, 2000 [online]. Available from URL: http://www.diabetes.com.au/pdf/obesity_report.pdf [Accessed 2006 Sep 9]

  29. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycaemia of type 2 diabetic patients. Diabetes Care 2003; 26: 881–5

    Article  PubMed  Google Scholar 

  30. Hanefeld M, Fischer S, Julius U, et al. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up. Diabetologia 1996; 39: 1577–83

    Article  PubMed  CAS  Google Scholar 

  31. Nakagami T, DECODA Study Group. Hyperglycaemia and mortality from all causes and from cardiovascular disease in five populations of Asian origin. Diabetologia 2004; 47: 385–94

    Article  PubMed  CAS  Google Scholar 

  32. Temelkova-Kurktschiev TS, Koehler C, Henkel E, et al. Postchallenge plasma glucose and glycemic spikes are more strongly associated with atherosclerosis than fasting glucose or HbA1c level. Diabetes Care 2000; 23: 1830–4

    Article  PubMed  CAS  Google Scholar 

  33. Tuomilehto J, Lindström J, Eriksson JG, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001; 344: 1343–50

    Article  PubMed  CAS  Google Scholar 

  34. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002; 346: 393–403

    Article  Google Scholar 

  35. Lindahl B. Primary prevention of type 2 diabetes: a matter of maintaining the new lifestyle [abstract]. 1st International Congress on Prediabetes and the Metabolic Syndrome, Berlin, Germany 2005 [online]. Available from URL: http://www.c-meondiabetes.com.au/pub/berlin_congress_prediabetes_metabolic_syndrome_2005.php [Accessed 2006 May 31]

  36. Holman RR, Blackwell L, Stratton IM, et al. Six-year results from the Early Diabetes Intervention Trial [abstract]. Diabetic Med 2003; 20Suppl. 2: 1–33, A54

    Google Scholar 

  37. Hanefeld M, Chiasson J–L, Koehler C, et al. Acarbose slows progression of intima-media thickness of the carotid arteries in subjects with impaired glucose tolerance. Stroke 2004; 35: 1073–8

    Article  PubMed  CAS  Google Scholar 

  38. Spengler M, Schmitz H, Landen H. Evaluation of the efficacy and tolerability of acarbose in patients with diabetes mellitus: a postmarketing surveillance study. Clin Drug Invest 2005; 25(10): 651–9

    Article  CAS  Google Scholar 

  39. Van de Laar FA, Lucassen PLBJ, Akkermans RP, et al. Alpha-glucosidase inhibitors for people with impaired glucose tolerance or impaired fasting blood glucose. Cochrane Database Sys Rev 2006; issue 4. Art. No.: CD005061. DOI: 10.1002/ 14651858.CD005061.pub2 [online]. Available from URL: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD005061/pdf_fs.html [Accessed 2007 Jan 24]

  40. Mooradian AD, Thurman JE. Drug therapy of postprandial hyperglycaemia. Drugs 1999; 57: 19–29

    Article  PubMed  CAS  Google Scholar 

  41. Hung Y-J, Kuo S–W, Wang C–H, et al. Postmarketing surveillance of acarbose treatment in Taiwanese patients with type 2 diabetes mellitus. Clin Drug Invest 2006; 26(10): 559–65

    Article  CAS  Google Scholar 

  42. Van de Laar FA, Lucassen PL, Akkermans RP, et al. α-Glucosidase inhibitors for patients with type 2 diabetes: results from a Cochrane systematic review and meta-analysis. Diabetes Care 2005; 28(1): 166–75

    Google Scholar 

  43. Lebovitz HE. α-Glucosidase inhibitors as agents in the treatment of diabetes. Diabetes Reviews 1998; 6(2): 132–45

    Google Scholar 

  44. Balfour JA, McTavish D. Acarbose: an update of its pharmacology and therapeutic use in diabetes mellitus. Drugs 1993; 46: 1025–54

    Article  PubMed  CAS  Google Scholar 

  45. Holman RR, Cull CA, Turner RC, et al. A randomized double-blind trial of acarbose in type 2 diabetes shows improved glycemic control over 3 years (UK Prospective Diabetes Study 44). Diabetes Care 1999; 22(6): 960–4

    Article  PubMed  CAS  Google Scholar 

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Acknowledgements

This study was sponsored by Bayer HealthCare. The sponsor was involved in the design and conduct of the study, collection, management, analysis and interpretation of the data, and preparation of the manuscript. The final manuscript version was approved by both authors.

The study is an accurate representation of the study results. Harald Landen is an employee of Bayer and is responsible for post-marketing surveillance studies at Bayer HealthCare. Dr Pan has no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Department of Endocrinology, 301 Hospital, 28 Fu-Xing Road, Beijing, China, 100853

    Chang-Yu Pan

  2. Bayer HealthCare, Leverkusen, Germany

    Harald Landen

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  1. Chang-Yu Pan
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Correspondence to Chang-Yu Pan.

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Pan, CY., Landen, H. Post-Marketing Surveillance of Acarbose Treatment in Patients with Type 2 Diabetes Mellitus and Subjects with Impaired Glucose Tolerance in China. Clin. Drug Investig. 27, 397–405 (2007). https://doi.org/10.2165/00044011-200727060-00003

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