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Postmarketing Surveillance Study of the Efficacy and Tolerability of Pioglitazone in Insulin-Resistant Patients with Type 2 Diabetes Mellitus in General Practice

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Abstract

Objective: To evaluate the efficacy and tolerability of pioglitazone in patients with type 2 diabetes mellitus treated in general practice settings.

Design and setting: This was a postmarketing surveillance study involving 2537 primary-care physicians throughout Germany.

Patients and interventions: A total of 8760 patients with type 2 diabetes were treated with pioglitazone 15 or 30mg once daily and followed for 16 weeks.

Results: Treatment with pioglitazone 15 or 30mg once daily was associated with a reduction in both fasting plasma glucose (mean 50.1 mg/dL) and glycosylated haemoglobin (HbA1c) [mean 1.4%] compared with baseline. The proportion of patients with ‘normal’ fasting glucose levels (70–110 mg/dL) increased from 2.3% at baseline to 24.2% at the final evaluation. Pioglitazone therapy was associated with a reduction in levels of triglycérides, total cholesterol and low-density lipoprotein (LDL)-cholesterol, and an increase in levels of high-density lipoprotein (HDL)-cholesterol. The proportion of patients at high risk of developing vascular complications decreased progressively during pioglitazone therapy according to a number of parameters.

Conclusions: Pioglitazone was well tolerated and effective in improving glycaemic control and lipid profiles in patients with type 2 diabetes. Pioglitazone may be effective in reducing the risk of vascular complications of diabetes.

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  1. 1The use of tradenames is for product identification purposes only and does not imply endorsement.

References

  1. International Diabetes Federation. Diabetes facts & figures [online]. Available from URL: http://www.idf.org. [Accessed 2003 May]

  2. Hogan P, Dall T, Nicolau P. American Diabetes Association —economic costs of diabetes in the US in 2002. Diabetes Care 2003; 26: 917–32

    Article  PubMed  Google Scholar 

  3. Mokdad AH, Bowman BA, Ford ES, et al. The continuing epidemics of obesity and diabetes in the United States. JAMA 2001; 286: 1195–200

    Article  PubMed  CAS  Google Scholar 

  4. Jonsson B. Revealing the cost of type II diabetes in Europe. Diabetologia 2002; 45: S5–12

    Article  PubMed  CAS  Google Scholar 

  5. Bagust A, Hopkinson PK, Maslove L, et al. The projected health care burden of type 2 diabetes in the UK from 2000 to 2060. Diabet Med 2002; 19Suppl. 4: 1–5

    Article  PubMed  Google Scholar 

  6. DCCT. 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 1993; 329: 977–86

    Article  Google Scholar 

  7. 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: 837–53

    Article  Google Scholar 

  8. Aronoff S, Rosenblatt S, Braithwaite S, et al. Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: a 6-month randomized placebo-controlled dose-response study: The Pioglitazone 001 Study Group. Diabetes Care 2000; 23: 1605–11

    Article  PubMed  CAS  Google Scholar 

  9. Einhorn D, Rendell M, Rosenzweig J, et al. 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 2000; 22: 1395–409

    Article  PubMed  CAS  Google Scholar 

  10. Kipnes MS, Krosnick A, Rendell MS, et al. 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: 10–7

    Article  PubMed  CAS  Google Scholar 

  11. Scherbaum WA, Goke B. Metabolic efficacy and safety of once-daily pioglitazone monotherapy in patients with type 2 diabetes: a double-blind, placebo-controlled study. Horm Metab Res 2002; 34: 589–95

    Article  PubMed  CAS  Google Scholar 

  12. Rosenstock J, Einhorn D, Hershon K, et al. Efficacy and safety of pioglitazone in type 2 diabetes: a randomised, placebocontrolled study in patients receiving stable insulin therapy. Int J Clin Pract 2002; 56: 251–7

    PubMed  CAS  Google Scholar 

  13. Khan MA, St Peter JV, Xue JL. A prospective, randomized comparison of the metabolic effects of pioglitazone or rosiglitazone in patients with type 2 diabetes who were previously treated with troglitazone. Diabetes Care 2002; 25: 708–11

    Article  PubMed  CAS  Google Scholar 

  14. Baba S. Pioglitazone: a review of Japanese clinical studies. Curr Med Res Opin 2001; 17: 166–89

    PubMed  CAS  Google Scholar 

  15. Gegick CG, Altheimer MD. Comparison of effects of thiazolidinediones on cardiovascular risk factors: observations from a clinical practice. Endocr Pract 2001; 7: 162–9

    PubMed  CAS  Google Scholar 

  16. Boyle PJ, King AB, Olansky L, et al. Effects of pioglitazone and rosiglitazone on blood lipid levels and glycemie control in patients with type 2 diabetes mellitus: a retrospective review of randomly selected medical records. Clin Ther 2002; 24: 378–96

    Article  PubMed  CAS  Google Scholar 

  17. Buchanan TA, Meehan WP, Jeng YY, et al. Blood pressure lowering by pioglitazone: evidence for a direct vascular effect. J Clin Invest 1995; 96: 354–60

    Article  PubMed  CAS  Google Scholar 

  18. Fullert S, Schneider F, Haak E, et al. Effects of pioglitazone in nondiabetic patients with arterial hypertension: a double-blind, placebo-controlled study. J Clin Endocrinol Metab 2002; 87: 5503–6

    Article  PubMed  CAS  Google Scholar 

  19. Hanefeld M, Belcher G. Safety profile of pioglitazone. Int J Clin Pract Suppl 2001; 121: 27–31

    PubMed  CAS  Google Scholar 

  20. Biermann E, Lübben G, Rihl J, et al. Micro- and macrovascular complications in insulin sensitive and insulin resistant diabetic patients: The IRIS Study. Diabetes 2002; 51Suppl. 2: 1759

    Google Scholar 

  21. Guidelines for Diabetes Care: European Diabetes Policy Group 1998, International Diabetes Federation, European region. Exp Clin Endocrinol Diabetes 1998; 106: 240–69

    Article  Google Scholar 

  22. Chilcott J, Tappenden P, Jones ML, et al. A systematic review of the clinical effectiveness of pioglitazone in the treatment of type 2 diabetes mellitus. Clin Ther 2001; 23: 1792–823

    Article  PubMed  CAS  Google Scholar 

  23. Chilcott J, Wight J, Lloyd Jones M, et al. The clinical effectiveness and cost-effectiveness of pioglitazone for type 2 diabetes mellitus: a rapid and systematic review. Health Technol Assess 2001; 5: 1–71

    PubMed  CAS  Google Scholar 

  24. Chilcott J, Wight J, Lloyd Jones M, et al. The clinical effectiveness and cost-effectiveness of pioglitazone for type 2 diabetes mellitus: a rapid and systematic review. Health Technol Assess 2001; 5: 1–61

    PubMed  CAS  Google Scholar 

  25. Coyle D, Palmer AJ, Tam R. Economic evaluation of pioglitazone hydrochloride in the management of type 2 diabetes mellitus in Canada. Pharmacoeconomics 2002; 20Suppl. 1: 31–42

    Article  PubMed  Google Scholar 

  26. Lambert C. Safety and tolerability of pioglitazone compared to metformin and gliclazide in type 2 diabetes. Results from active comparator trials. Diabetes 2003; 52Suppl. 1: 1949

    Google Scholar 

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Acknowledgements

This study was supported by Takeda GmbH, Aachen, Germany.

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Authors and Affiliations

  1. Abteilung Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Carl-Neuberg-Strasse 1, Hannover, 30625, Germany

    Christof Schöfl

  2. Takeda Pharma GmbH, Aachen, Germany

    Georg Lübben

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  1. Christof Schöfl
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  2. Georg Lübben
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Correspondence to Christof Schöfl.

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Schöfl, C., Lübben, G. Postmarketing Surveillance Study of the Efficacy and Tolerability of Pioglitazone in Insulin-Resistant Patients with Type 2 Diabetes Mellitus in General Practice. Clin. Drug Investig. 23, 725–734 (2003). https://doi.org/10.2165/00044011-200323110-00005

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  • DOI: https://doi.org/10.2165/00044011-200323110-00005

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