Advertisement

Journal of Endocrinological Investigation

, Volume 34, Issue 10, pp 781–787 | Cite as

Which is the eligible patient to be treated with pioglitazone? The expert view

  • A. Avogaro
  • M. Federici
  • J. Betteridge
  • R. Bonadonna
  • I. W. Campbell
  • G. H. Schernthaner
  • B. Staels
  • E. Farinaro
  • G. Crepaldi
Opinion

Key-words

Patient peroxisome proliferator-activated receptor gamma pioglitazone thiazolidinedione Type 2 diabetes 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Lupi R, Del Prato S. Beta-cell apoptosis in type 2 diabetes: quantitative and functional consequences. Diabetes Metab 2008, 34(Suppl 2): S56–64.PubMedCrossRefGoogle Scholar
  2. 2.
    Levy J, Atkinson AB, Bell PM, McCance DR, Hadden DR. Beta-cell deterioration determines the onset and rate of progression of secondary dietary failure in type 2 diabetes mellitus: the 10-year follow-up of the Belfast Diet Study. Diabet Med 1998, 15: 290–6.PubMedCrossRefGoogle Scholar
  3. 3.
    Bagust A, Beale S. Deteriorating beta-cell function in type 2 diabetes: a long-term model. QJM 2003, 96: 281–8.PubMedCrossRefGoogle Scholar
  4. 4.
    Whitcomb RW, Saltiel AR, Lockwood DH. New therapies for noninsulin dependent diabetes mellitus: thiazolidinediones. In: LeRoith D, Taylor SI, Olefsky JM eds. Diabetes mellitus. Philadelphia: Lippincott-Raven. 1996, 661–8.Google Scholar
  5. 5.
    Balfour JA, Plosker GL. Rosiglitazone. Drugs 1999, 57: 921–30.PubMedCrossRefGoogle Scholar
  6. 6.
    Diani AR, Sawada G, Wyse B, Murray FT, Khan M. Pioglitazone preserves pancreatic islet structure and insulin secretory function in three murine models of type 2 diabetes. Am J Physiol Endocrinol Metab 2004, 286: E116–22.PubMedCrossRefGoogle Scholar
  7. 7.
    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: 2427–43.PubMedCrossRefGoogle Scholar
  8. 8.
    Aronoff, S, Rosenblatt S, Braithwaite S, Egan JW, Mathisen AL, Schneider RL. 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.PubMedCrossRefGoogle Scholar
  9. 9.
    Miyazaki Y, Mahankali A, Matsuda M, et al. Improved glycemic control and enhanced insulin sensitivity in type 2 diabetic subjects treated with pioglitazone. Diabetes Care 2001, 24: 710–9.PubMedCrossRefGoogle Scholar
  10. 10.
    Miyazaki Y, Mahankali A, Matsuda M, et al. Effect of pioglitazone on abdominal fat distribution and insulin sensitivity in type 2 diabetic patients. J Clin Endocrinol Metab 2002, 87: 2784–91.PubMedCrossRefGoogle Scholar
  11. 11.
    Bajaj M, Suraamornkul S, Pratipanawatr T, et al. Pioglitazone reduces hepatic fat content and augments splanchnic glucose uptake in patients with type 2 diabetes. Diabetes 2003, 52: 1364–70.PubMedCrossRefGoogle Scholar
  12. 12.
    Kipnes MS, Krosnick A, Rendell MS, Egan JW, Mathisen AL, Schneider RL. 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.PubMedCrossRefGoogle Scholar
  13. 13.
    Pavo I, Jermendy G, Varkonyi TT, et al. Effect of pioglitazone compared with metformin on glycemic control and indicators of insulin sensitivity in recently diagnosed patients with type 2 diabetes. J Clin Endocrinol Metab 2003, 88: 1637–45.PubMedCrossRefGoogle Scholar
  14. 14.
    Schernthaner G, Matthews DR, Charbonnel B, Hanefeld M, Brunetti P; Quartet (corrected) Study Group. Efficacy and safety of pioglitazone versus metformin in patients with type 2 diabetes mellitus: a double-blind, randomized trial. J Clin Endocrinol Metab 2004, 89: 6068–76.PubMedCrossRefGoogle Scholar
  15. 15.
    Charbonnel BH, Matthews DR, Schernthaner G, Hanefeld M, Brunetti P; QUARTET Study Group. A long-term comparison of pioglitazone and gliclazide in patients with Type 2 diabetes mellitus: a randomized, double-blind, parallel-group comparison trial. Diabet Med 2005, 22: 399–405.PubMedCrossRefGoogle Scholar
  16. 16.
    Mazzone T, Meyer PM, Feinstein SB, et al. Effect of pioglitazone compared with glimepiride on carotid artery intima-media thickness in type 2 diabetes: a randomized trial. JAMA 2006, 296: 2572–81.PubMedCrossRefGoogle Scholar
  17. 17.
    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: 1279–89.PubMedCrossRefGoogle Scholar
  18. 18.
    Charbonnel B, Schernthaner G, Brunetti P, et al. Long-term efficacy and tolerability of add-on pioglitazone therapy to failing monotherapy compared with addition of gliclazide or metformin in patients with type 2 diabetes. Diabetologia 2005, 48: 1093–104.PubMedCrossRefGoogle Scholar
  19. 19.
    Chalmers J, Hunter JE, Robertson SJ, et al. Effects of early use of pioglitazone in combination with metformin in patients with newly diagnosed type 2 diabetes. Curr Med Res Opin 2007, 23: 1775–81.PubMedCrossRefGoogle Scholar
  20. 20.
    Belfort R, Harrison SA, Brown K, et al. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med 2006, 355: 2297–307.PubMedCrossRefGoogle Scholar
  21. 21.
    Basu R, Shah P, Basu A, et al. Comparison of the effects of pioglitazone and metformin on hepatic and extra-hepatic insulin action in people with type 2 diabetes. Diabetes 2008, 57: 24–31.PubMedCrossRefGoogle Scholar
  22. 22.
    Naoumova RP, Kindler H, Leccisotti L, et al. Pioglitazone improves myocardial blood flow and glucose utilization in nondiabetic patients with combined hyperlipidemia: a randomized, double-blind, placebo-controlled study. J Am Coll Cardiol 2007, 50: 2051–8.PubMedCrossRefGoogle Scholar
  23. 23.
    Ishida H, Takizawa M, Ozawa S, et al. Pioglitazone improves insulin secretory capacity and prevents the loss of beta-cell mass in obese diabetic db/db mice: Possible protection of beta cells from oxidative stress. Metabolism 2004, 53: 488–94.PubMedCrossRefGoogle Scholar
  24. 24.
    Zeender E, Maedler K, Bosco D, Berney T, Donath MY, Halban PA. Pioglitazone and sodium salicylate protect human beta-cells against apoptosis and impaired function induced by glucose and interleukin-1beta. J Clin Endocrinol Metab 2004, 89: 5059–66.PubMedCrossRefGoogle Scholar
  25. 25.
    Gastaldelli A, Casolaro A, Pettiti M, et al. Effect of pioglitazone on the metabolic and hormonal response to a mixed meal in type II diabetes. Clin Pharmacol Ther 2007, 81: 205–12.PubMedCrossRefGoogle Scholar
  26. 26.
    Takagi T, Yamamuro A, Tamita K, et al. Pioglitazone reduces neointimal tissue proliferation after coronary stent implantation in patients with type 2 diabetes mellitus: an intravascular ultrasound scanning study. Am Heart J 2003, 146: E5.PubMedCrossRefGoogle Scholar
  27. 27.
    Marx N, Wöhrle J, Nusser T, et al. Pioglitazone reduces neointima volume after coronary stent implantation: a randomized, placebo-controlled, double-blind trial in nondiabetic patients. Circulation 2005, 112: 2792–8.PubMedCrossRefGoogle Scholar
  28. 28.
    Erdmann E, Dormandy JA, Charbonnel B, Massi-Benedetti M, Moules IK, Skene AM; PROactive Investigators. The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study. J Am Coll Cardiol 2007, 49: 1772–80.PubMedCrossRefGoogle Scholar
  29. 29.
    Wilcox R, Bousser MG, Betteridge DJ, et al; PROactive Investigators. Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: results from the PROactive (PROspective pioglitAzone Clinical Trial in macroVascular Events 04). Stroke 2007, 38: 865–73.PubMedCrossRefGoogle Scholar
  30. 30.
    Erdmann E, Charbonnel B, Wilcox RG, et al. Pioglitazone use and heart failure in patients with type 2 diabetes and preexisting cardiovascular disease: data from the PROactive study (PROactive 08). Diabetes Care 2007, 30: 2773–8.PubMedCrossRefGoogle Scholar
  31. 31.
    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: 1180–8.PubMedCrossRefGoogle Scholar
  32. 32.
    Davidson M, Meyer PM, Haffner S, et al. Increased high-density lipoprotein cholesterol predicts the pioglitazone-mediated reduction of carotid intima-media thickness progression in patients with type 2 diabetes mellitus. Circulation 2008, 117: 2123–30.PubMedCrossRefGoogle Scholar
  33. 33.
    Nissen SE, Nicholls SJ, Wolski K, et al. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA 2008, 299: 1561–73.PubMedCrossRefGoogle Scholar
  34. 34.
    van der Meer RW, Rijzewijk LJ, de Jong HW, et al. Pioglitazone improves cardiac function and alters myocardial substrate metabolism without affecting cardiac triglyceride accumulation and high-energy phosphate metabolism in patients with well-controlled type 2 diabetes mellitus. Circulation 2009, 119: 2069–77.PubMedCrossRefGoogle Scholar
  35. 35.
    Kaneda H, Shiono T, Miyashita Y, et al. Efficacy and safety of pioglitazone in patients with ST elevation myocardial infarction treated with primary stent implantation. Heart 2009, 95: 1079–84.PubMedCrossRefGoogle Scholar
  36. 36.
    Goldberg RB, Kendall DM, Deeg MA, et al. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care 2005, 28: 1547–54.PubMedCrossRefGoogle Scholar
  37. 37.
    Deeg MA, Buse JB, Goldberg RB, et al; GLAI Study Investigators. Pioglitazone and riosiglitazone have different effects on serum lipoprotein particle concentrations and sizes in patients with type 2 diabetes and dyslipidemia. Diabetes Care 2007, 30: 2458–64.PubMedCrossRefGoogle Scholar
  38. 38.
    Tzoulaki I, Molokhia M, Curcin V, et al. Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using UK general practice research database. BMJ 2009, 339: b4731.PubMedCentralPubMedCrossRefGoogle Scholar
  39. 39.
    Juurlink DN, Gomes T, Lipscombe LL, Austin PC, Hux JE, Mamdani MM. Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: population based cohort study. BMJ 2009, 339: b2942.PubMedCentralPubMedCrossRefGoogle Scholar
  40. 40.
    Richter B, Bandeira-Echtler E, Bergerhoff K, Clar C, Ebrahim SH. Pioglitazone for type 2 diabetes mellitus. Cochrane Database Syst Rev 2006, 4: CD006060.PubMedGoogle Scholar
  41. 41.
    Belcher G, Schernthaner G. Changes in liver tests during 1-year treatment of patients with Type 2 diabetes with pioglitazone, metformin or gliclazide. Diabet Med 2005, 22: 973–9.PubMedCrossRefGoogle Scholar
  42. 42.
    Tan M, Johns D, González Gálvez G, et al; GLAD Study Group. Effects of pioglitazone and glimepiride on glycemic control and insulin sensitivity in Mexican patients with type 2 diabetes mellitus: A multicenter, randomized, double-blind, parallel-group trial. Clin Ther 2004, 26: 680–93.PubMedCrossRefGoogle Scholar
  43. 43.
    Mattoo V, Eckland D, Widel M, et al; H6E-MC-GLAT study group. Metabolic effects of pioglitazone in combination with insulin in patients with type 2 diabetes mellitus whose disease is not adequately controlled with insulin therapy: results of a six-month, randomized, double-blind, prospective, multicenter, parallel-group study. Clin Ther 2005, 27: 554–67.PubMedCrossRefGoogle Scholar
  44. 44.
    Raz I, Stranks S, Filipczak R, et al. Efficacy and safety of biphasic insulin aspart 30 combined with pioglitazone in type 2 diabetes poorly controlled on glibenclamide (glyburide) monotherapy or combination therapy: an 18-week, randomized, open-label study. Clin Ther 2005, 27: 1432–43.PubMedCrossRefGoogle Scholar
  45. 45.
    Davidson JA, Perez A, Zhang J; Pioglitazone 343 Study Group. Addition of pioglitazone to stable insulin therapy in patients with poorly controlled type 2 diabetes: results of a double-blind, multicentre, randomized study. Diabetes Obes Metab 2006, 8: 164–74.PubMedCrossRefGoogle Scholar
  46. 46.
    Umpierrez G, Issa M, Vlajnic A. Glimepiride versus pioglitazone combination therapy in subjects with type 2 diabetes inadequately controlled on metformin monotherapy: results of a randomized clinical trial. Curr Med Res Opin 2006, 22: 751–9.PubMedCrossRefGoogle Scholar
  47. 47.
    Jain R, Osei K, Kupfer S, Perez AT, Zhang J. Long-term safety of pioglitazone versus glyburide in patients with recently diagnosed type 2 diabetes mellitus. Pharmacotherapy 2006, 26: 1388–95.PubMedCrossRefGoogle Scholar
  48. 48.
    Rosenstock J, Kim SW, Baron MA, et al. Efficacy and tolerability of initial combination therapy with vildagliptin and pioglitazone compared with component monotherapy in patients with type 2 diabetes. Diabetes Obes Metab 2007, 9: 175–85.PubMedCrossRefGoogle Scholar
  49. 49.
    Berhanu P, Perez A, Yu S. Effect of pioglitazone in combination with insulin therapy on glycaemic control, insulin dose requirement and lipid profile in patients with type 2 diabetes previously poorly controlled with combination therapy. Diabetes Obes Metab 2007, 9: 512–20.PubMedCrossRefGoogle Scholar
  50. 50.
    Kaku K. Efficacy and safety of therapy with metformin plus pioglitazone in the treatment of patients with type 2 diabetes: a double-blind, placebo-controlled, clinical trial. Curr Med Res Opin 2009, 25: 1111–9.PubMedCrossRefGoogle Scholar
  51. 51.
    Langenfeld MR, Forst T, Hohberg C, et al. Pioglitazone decreases carotid intima-media thickness independently of glycemic control in patients with type 2 diabetes mellitus: results from a controlled randomized study. Circulation 2005, 111: 2525–31.PubMedCrossRefGoogle Scholar
  52. 52.
    Health Canada. Health Canada endorsed important safety information on PrACTOS® (pioglitazone hydrochloride). April 18, 2007. Available at: http://www.hc-sc.gc.ca/dhp-mps/medeff/advisoriesavis/prof/2007/actos_hpc-cps_2_e.html. Accessed May 1, 2008.
  53. 53.
    McDonough AK, Rosenthal RS, Cao X, Saag KG. The effect of thiazolidinediones on BMD and osteoporosis. Nat Clin Pract Endocrinol Metab 2008, 4: 4507–13.CrossRefGoogle Scholar
  54. 54.
    Dormandy J, Bhattacharya M, van Troostenburg de Bruyn AR; PROactive investigators. Safety and tolerability of pioglitazone in high-risk patients with type 2 diabetes: an overview of data from PROactive. Drug Saf 2009, 32: 187–202.PubMedCrossRefGoogle Scholar
  55. 55.
    Loke YK, Singh S, Furberg CD. Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta-analysis. CMAJ 2009, 180: 32–9.PubMedCentralPubMedCrossRefGoogle Scholar
  56. 56.
    Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007, 356: 2457–71.PubMedCrossRefGoogle Scholar
  57. 57.
    Nathan DM, Buse JB, Davidson MB, et al.; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009, 32: 193–203.PubMedCentralPubMedCrossRefGoogle Scholar

Copyright information

© Italian Society of Endocrinology (SIE) 2011

Authors and Affiliations

  • A. Avogaro
    • 1
  • M. Federici
    • 2
  • J. Betteridge
    • 3
  • R. Bonadonna
    • 4
  • I. W. Campbell
    • 5
  • G. H. Schernthaner
    • 6
  • B. Staels
    • 7
  • E. Farinaro
    • 8
  • G. Crepaldi
    • 9
  1. 1.Department of Clinical and Experimental MedicineUniversity of PaduaPaduaItaly
  2. 2.Laboratory of Molecular Medicine, Department of Internal MedicineUniversity of Rome “Tor Vergata”RomeItaly
  3. 3.Department of MedicineRoyal Free and University College Medical School, Middlesex HospitalLondonUK
  4. 4.Department of Biomedical and Surgical SciencesUniversity of VeronaVeronaItaly
  5. 5.Department of Biological and Biomedical SciencesUniversity of St. AndrewsFifeUK
  6. 6.Department of Internal Medicine IIMedical University of ViennaViennaAustria
  7. 7.Department of Atherosclerosis, U545 Inserm, Institute Pasteur de LilleUniversity of Lille 2LilleFrance
  8. 8.Department of Preventive Medical SciencesFederico II University of NaplesNaplesItaly
  9. 9.Department of Medical and Surgical SciencesUniversity of PaduaPaduaItaly

Personalised recommendations