YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Effects of Pioglitazone and Rosiglitazone on Glucose and the Cardiovascular Risk Factors in Patients with Type 2 Diabetes: A Meta-analysis

Pioglitazone과 Rosiglitazone이 제2형 당뇨환자의 혈당조절 및 심혈관계 위험인자에 미치는 효과에 대한 메타분석

  • Lee, Jae-Kyoung (Pharmaceuticals Development Team, Yuhan corporation) ;
  • Lee, Eui-Kyung (Graduate School of Clinical Pharmacy, Sookmyung Women's University)
  • 이재경 (주식회사 유한양행 개발실) ;
  • 이의경 (숙명여자대학교 임상약학대학원)
  • Received : 2009.08.15
  • Accepted : 2009.11.04
  • Published : 2009.12.31
Download PDF
⟨ Previous Next ⟩

Abstract

A meta-analysis of 63 randomized controlled trials of Pioglitazone and Rosiglitazone in patients with type 2 diabetes was conducted. Pioglitazone significantly lowered fasting plasma glucose and triglyceride (TG) level and increased high-density lipoprotein cholesterol (HDL) level. Rosiglitazone significantly lowered hemoglobin A1C level and fasting plasma glucose, whereas it increased all kinds of lipids (HDL, LDL (low-density lipoprotein cholesterol), TG, total cholesterol). In comparison, glucose lowering effect was higher in Rosiglitazone, and Pioglitazone produced a more favorable lipid profile.

Keywords

References

  1. 한국보건사회연구원 : 2001년도 국민건강 영양조사-만성질병편, 보건복지부 (2002)
  2. 대한의사협회 의료정책연구소 : 보건의료 통계 분석-OECD 보건 통계 자료를 기초로-Analysis of the OECD Health Data 2006, 연구보고서 제2007-3호, pp. 32-33 (2007)
  3. IMS Health, National Disease and Therapeutic Index, Data for 2007 (Database). Extracted January–march
  4. Chiquette, E., Ramirez, G. and DeFronzo, R. : A meta-analysis comparing the effect of thiazolidinediones on cardiovascular risk factors. Archives of Internal Medicine. 164, 2097 (2004) https://doi.org/10.1001/archinte.164.19.2097
  5. Aronoff, S., Rosenblatt, S., Braithwaite, S., Egan, J. W., Mathisen, A. L. and Schneider, R. L. : 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. 23, 1605 (2000) https://doi.org/10.2337/diacare.23.11.1605
  6. Bays, H., McElhattan, J. and Bryzinski, B. S. : A double-blind, randomised trial of tesaglitazar versus pioglitazone in patients with type 2 diabetes mellitus. Diab. Vasc. Dis. Res. 4, 181 (2007) https://doi.org/10.3132/dvdr.2007.039
  7. Belcher, G., Lambert, C., Edwards, G., Urquhart, R. and Matthews, D. R. : Safety and tolerability of pioglitazone, metformin, and gliclazide in the treatment of type 2 diabetes. Diabetes Res. Clin. Pract. 70, 53 (2005) https://doi.org/10.1016/j.diabres.2005.02.011
  8. Bluher, M., Lubben, G. and Paschke, R. : Analysis of the relationship between the Pro12Ala variant in the PPARgamma2 gene and the response rate to therapy with pioglitazone in patients with type 2 diabetes. Diabetes Care. 26, 825 (2003) https://doi.org/10.2337/diacare.26.3.825
  9. Davidson, J. A., Perez, A. and Zhang, J. : 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. 8, 164 (2006) https://doi.org/10.1111/j.1463-1326.2005.00499.x
  10. Derosa, G., Cicero, A. F., D'Angelo, A., Gaddi, A., Ciccarelli, L., Piccinni, M. N., Salvadeo, S. A., Pricolo, F., Ferrari, I., Gravina, A. and Ragonesi, P. D. : Effects of 1 year of treatment with pioglitazone or rosiglitazone added to glimepiride on lipoprotein (a) and homocysteine concentrations in patients with type 2 diabetes mellitus and metabolic syndrome: a multicenter, randomized, double-blind, controlled clinical trial. Clin. Ther. 28, 679 (2006) https://doi.org/10.1016/j.clinthera.2006.05.012
  11. Derosa, G., Cicero, A. F., Dangelo, A., Gaddi, A., Ragonesi, P. D., Piccinni, M. N., Salvadeo, S., Ciccarelli, L., Pricolo, F., Ghelfi, M., Ferrari, I., Montagna, L. and Fogari, R. : Thiazolidinedione effects on blood pressure in diabetic patients with metabolic syndrome treated with glimepiride. Hypertens Res. 28, 917 (2005) https://doi.org/10.1291/hypres.28.917
  12. Derosa, G., D'Angelo, A., Ragonesi, P. D., Ciccarelli, L., Piccinni, M. N., Pricolo, F., Salvadeo, S. A., Montagna, L., Gravina, A., Ferrari, I., Paniga, S. and Cicero, A. F. : Metabolic effects of pioglitazone and rosiglitazone in patients with diabetes and metabolic syndrome treated with metformin. Intern. Med. J. 37, 79 (2007) https://doi.org/10.1111/j.1445-5994.2007.01238.x
  13. Forst, T., Lubben, G., Hohberg, C., Kann, P., Sachara, C., Gottschall, V., Friedrich, C., Rosskopf, R. and Pfutzner, A. : Influence of glucose control and improvement of insulin resistance on microvascular blood flow and endothelial function in patients with diabetes mellitus type 2. Microcirculation 12, 543 (2005) https://doi.org/10.1080/10739680500253402
  14. Garber, A. J., Schweizer, A., Baron, M. A., Rochotte, E. and Dejager, S. : Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebocontrolled study. Diabetes Obes Metab. 9, 166 (2007) https://doi.org/10.1111/j.1463-1326.2006.00684.x
  15. Gastaldelli, A., Ferrannini, E., Miyazaki, Y., Matsuda, M., Mari, A. and DeFronzo, R. A. : Thiazolidinediones improve beta-cell function in type 2 diabetic patients. Am. J. Physiol. Endocrinol. Metab. 292, E871 (2007) https://doi.org/10.1152/ajpendo.00551.2006
  16. Gerber, P., Lubben, G., Heusler, S. and Dodo, A. : Effects of pioglitazone on metabolic control and blood pressure: a randomised study in patients with type 2 diabetes mellitus. Curr. Med. Res. Opin. 19, 532 (2003) https://doi.org/10.1185/030079903125002180
  17. Herz, M., Johns, D., Reviriego, J., Grossman, L. D., Godin, C., Duran, S., Hawkins, F., Lochnan, H., Escobar-Jimenez, F., Hardin, P. A., Konkoy, C. S. and Tan, M. H. : A randomized, double-blind, placebo-controlled, clinical trial of the effects of pioglitazone on glycemic control and dyslipidemia in oral antihyperglycemic medication-naive patients with type 2 diabetes mellitus. Clin. Ther. 25, 1074 (2003) https://doi.org/10.1016/S0149-2918(03)80068-1
  18. Kipnes, M. S., Krosnick, A., Rendell, M. S., Egan, J. W., Mathisen, A. L. and Schneider, R. L. : 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. 111, 10 (2001)
  19. Langenfeld, M. R., Forst, T., Hohberg, C., Kann, P., Lubben, G., Konrad, T., Fullert, S. D., Sachara, C. and Pfutzner, A. : Pioglitazone decreases carotid intima-media thickness independently of glycemic control in patients with type 2 diabetes mellitus: results from a controlled randomized study. Circulation 111, 2525 (2005) https://doi.org/10.1161/01.CIR.0000165072.01672.21
  20. Majima, T., Komatsu, Y., Doi, K., Shigemoto, M., Takagi, C., Fukao, A., Corners, J. and Nakao, K. : Safety and efficacy of low-dose pioglitazone (7.5 mg/day) vs. standard-dose pioglitazone (15 mg/day) in Japanese women with type 2 diabetes mellitus. Endocr. J. 53, 325 (2006) https://doi.org/10.1507/endocrj.K05-067
  21. Miyazaki, Y., Matsuda, M. and DeFronzo, R. A. : Doseresponse effect of pioglitazone on insulin sensitivity and insulin secretion in type 2 diabetes. Diabetes Care. 25, 517 (2002) https://doi.org/10.2337/diacare.25.3.517
  22. Scherbaum, W. A. and 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. 34, 589 (2002)
  23. Smith, S. R., De Jonge, L., Volaufova, J., Li, Y., Xie, H. and Bray, G. A. : Effect of pioglitazone on body composition and energy expenditure: a randomized controlled trial. Metabolism. 54, 24 (2005)
  24. Wallace, T. M., Levy, J. C. and Matthews, D. R. : An increase in insulin sensitivity and basal beta-cell function in diabetic subjects treated with pioglitazone in a placebo-controlled randomized study. Diabet Med. 21, 568 (2004) https://doi.org/10.1111/j.1464-5491.2004.01218.x
  25. Watanabe, I., Tani, S., Anazawa, T., Kushiro, T. and Kanmatsuse, K. : Effect of pioglitazone on arteriosclerosis in comparison with that of glibenclamide. Diabetes Res. Clin. Pract. 68, 104 (2005) https://doi.org/10.1016/j.diabres.2004.09.013
  26. Albertini, J. P., McMorn, S. O., Chen, H., Mather, R. A. and Valensi, P. : Effect of rosiglitazone on factors related to endothelial dysfunction in patients with type 2 diabetes mellitus. Atherosclerosis. 195, e159 (2007) https://doi.org/10.1016/j.atherosclerosis.2007.01.003
  27. Baksi, A., James, R. E., Zhou, B. and Nolan, J. J. : Comparison of uptitration of gliclazide with the addition of rosiglitazone to gliclazide in patients with type 2 diabetes inadequately controlled on half-maximal doses of a sulphonylurea. Acta Diabetol. 41, 63 (2004)
  28. Davidson, J. A., McMorn, S. O., Waterhouse, B. R. and Cobitz, A. R. : A 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and tolerability of combination therapy with rosiglitazone and sulfonylurea in African American and Hispanic American patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy. Clin. Ther. 29, 1900 (2007) https://doi.org/10.1016/j.clinthera.2007.09.011
  29. DeFronzo, R. A., Bergenstal, R. M., Cefalu, W. T., Pullman, J., Lerman, S., Bode, B. W. and Phillips, L. S. : Efficacy of inhaled insulin in patients with type 2 diabetes not controlled with diet and exercise: A 12-week, randomized, comparative trial. Diabetes Care. 28, 1922 (2005) https://doi.org/10.2337/diacare.28.8.1922
  30. Derosa, G., Gaddi, A. V., Ciccarelli, L., Fogari, E., Ghelfi, M., Ferrari, I. and Cicero, A. F. : Long-term effect of glimepiride and rosiglitazone on non-conventional cardiovascular risk factors in metformin-treated patients affected by metabolic syndrome: a randomized, double-blind clinical trial. J. Int. Med. Res. 33, 284 (2005) https://doi.org/10.1177/147323000503300303
  31. Fonseca, V., Rosenstock, J., Patwardhan, R. and Salzman, A. : Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. JAMA 283, 1695 (2000) https://doi.org/10.1001/jama.283.13.1695
  32. Freed, M. I., Ratner, R., Marcovina, S. M., Kreider, M. M., Biswas, N., Cohen, B. R. and Brunzell, J. D. : Effects of rosiglitazone alone and in combination with atorvastatin on the metabolic abnormalities in type 2 diabetes mellitus. Am. J. Cardiol. 90, 947 (2002) https://doi.org/10.1016/S0002-9149(02)02659-0
  33. Goldstein, B. J., Cobitz, A. R., Hand, L. M. and Chen, H. : Are the metabolic effects of rosiglitazone influenced by baseline glycaemic control? Curr. Med. Res. Opin. 19, 192 (2003) https://doi.org/10.1185/030079903125001695
  34. Gomez-Perez, F. J., Fanghanel-Salmon, G., Antonio Barbosa, J., Montes-Villarreal, J., Berry, R. A., Warsi, G. and Gould, E. M. : Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes. Diabetes Metab. Res. Rev. 18, 127 (2002) https://doi.org/10.1002/dmrr.264
  35. Hallsten, K., Virtanen, K. A., Lonnqvist, F., Sipila, H., Oksanen, A., Viljanen, T., Ronnemaa, T., Viikari, J., Knuuti, J. and Nuutila, P. : Rosiglitazone but not metformin enhances insulin- and exercise-stimulated skeletal muscle glucose uptake in patients with newly diagnosed type 2 diabetes. Diabetes. 51, 3479 (2002) https://doi.org/10.2337/diabetes.51.12.3479
  36. Hanefeld, M., Patwardhan, R. and Jones, N. P. : A one-year study comparing the efficacy and safety of rosiglitazone and glibenclamide in the treatment of type 2 diabetes. Nutr. Metab. Cardiovasc. Dis. 17, 13 (2007) https://doi.org/10.1016/j.numecd.2005.12.003
  37. Jung, H. S., Youn, B. S., Cho, Y. M., Yu, K. Y., Park, H. J., Shin, C. S., Kim, S. Y., Lee, H. K. and Park, K. S. : The effects of rosiglitazone and metformin on the plasma concentrations of resistin in patients with type 2 diabetes mellitus. Metabolism. 54, 314 (2005) https://doi.org/10.1016/j.metabol.2004.05.019
  38. Kadoglou, N. P. E., Iliadis, F., Liapis, C. D., Perrea, D., Angelopoulou, N. and Alevizos, M. : Beneficial effects of combined treatment with rosiglitazone and exercise on cardiovascular risk factors in patients with type 2 diabetes. Diabetes Care. 30, 2242 (2007) https://doi.org/10.2337/dc07-0341
  39. Kerenyi, Z., Samer, H., James, R., Yan, Y. and Stewart, M. : Combination therapy with rosiglitazone and glibenclamide compared with upward titration of glibenclamide alone in patients with type 2 diabetes mellitus. Diabetes Res. Clin. Pract. 63, 213 (2004) https://doi.org/10.1016/j.diabres.2003.09.009
  40. Kim, Y. M., Cha, B. S., Kim, D. J., Choi, S. H., Kim, S. K., Ahn, C. W., Lim, S. K., Kim, K. R., Huh, K. B. and Lee, H. C. : Predictive clinical parameters for therapeutic efficacy of rosiglitazone in Korean type 2 diabetes mellitus. Diabetes Res. Clin. Pract. 67, 43 (2005) https://doi.org/10.1016/j.diabres.2004.05.001
  41. Ko, S. H., Song, K. H., Ahn, Y. B., Yoo, S. J., Son, H. S., Yoon, K. H., Cha, B. Y., Lee, K. W., Son, H. Y. and Kang, S. K. : The effect of rosiglitazone on serum lipoprotein(a) levels in Korean patients with type 2 diabetes mellitus. Metabolism. 52, 731 (2003) https://doi.org/10.1016/S0026-0495(03)00033-7
  42. Lebovitz, H. E., Dole, J. F., Patwardhan, R., Rappaport, E. B. and Freed, M. I. : Rosiglitazone monotherapy is effective in patients with type 2 diabetes. J. Clin. Endocrinol. Metab. 86, 280 (2001) https://doi.org/10.1210/jc.86.1.280
  43. Miyazaki, Y., Glass, L., Triplitt, C., Matsuda, M., Cusi, K., Mahankali, A., Mahankali, S., Mandarino, L. J. and DeFronzo, R. A. : Effect of rosiglitazone on glucose and non-esterified fatty acid metabolism in Type II diabetic patients. Diabetologia. 44, 2210 (2001) https://doi.org/10.1007/s001250100031
  44. Natali, A., Baldeweg, S., Toschi, E., Capaldo, B., Barbaro, D., Gastaldelli, A., Yudkin, J. S. and Ferrannini, E. : Vascular effects of improving metabolic control with metformin or rosiglitazone in type 2 diabetes. Diabetes Care. 27, 1349 (2004) https://doi.org/10.2337/diacare.27.6.1349
  45. Negro, R., Mangieri, T., Dazzi, D., Pezzarossa, A. and Hassan, H. : Rosiglitazone effects on blood pressure and metabolic parameters in nondipper diabetic patients. Diabetes Res. Clin. Pract. 70, 20 (2005) https://doi.org/10.1016/j.diabres.2005.02.012
  46. Patel, J., Anderson, R. J. and Rappaport, E. B. : Rosiglitazone monotherapy improves glycaemic control in patients with type 2 diabetes: a twelve-week, randomized, placebo-controlled study. Diabetes Obes. Metab. 1, 165 (1999) https://doi.org/10.1046/j.1463-1326.1999.00020.x
  47. Phillips, L. S., Grunberger, G., Miller, E., Patwardhan, R., Rappaport, E. B. and Salzman, A. : Once- and twice-daily dosing with rosiglitazone improves glycemic control in patients with type 2 diabetes. Diabetes Care. 24, 308 (2001) https://doi.org/10.2337/diacare.24.2.308
  48. Rahman, S., Ismail, A. A., Ismail, S. B., Naing, N. N. and Abdul Rahman, A. R. : Effect of rosiglitazone/ramipril on preclinical vasculopathy in newly diagnosed, untreated diabetes and IGT patients: 1-year randomised, double-blind, placebo-controlled study. Eur. J. Clin. Pharmacol. 63, 733 (2007) https://doi.org/10.1007/s00228-007-0315-3
  49. Raskin, P., Rendell, M., Riddle, M. C., Dole, J. F., Freed, M. I. and Rosenstock, J. : A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Diabetes Care. 24, 1226 (2001) https://doi.org/10.2337/diacare.24.7.1226
  50. Rosenstock, J., Baron, M. A., Dejager, S., Mills, D. and Schweizer, A. : Comparison of vildagliptin and rosiglitazone monotherapy in patients with type 2 diabetes: a 24-week, double-blind, randomized trial. Diabetes Care. 30, 217 (2007) https://doi.org/10.2337/dc06-1815
  51. Seber, S., Ucak, S., Basat, O. and Altuntas, Y. : The effect of dual PPAR alpha/gamma stimulation with combination of rosiglitazone and fenofibrate on metabolic parameters in type 2 diabetic patients. Diabetes Res. Clin. Pract. 71, 52 (2006) https://doi.org/10.1016/j.diabres.2005.05.009
  52. St John Sutton, M., Rendell, M., Dandona, P., Dole, J. F., Murphy, K., Patwardhan, R., Patel, J. and Freed, M. : A comparison of the effects of rosiglitazone and glyburide on cardiovascular function and glycemic control in patients with type 2 diabetes. Diabetes Care. 25, 2058 (2002) https://doi.org/10.2337/diacare.25.11.2058
  53. Stocker, D. J., Taylor, A. J., Langley, R. W., Jezior, M. R. and Vigersky, R. A. : A randomized trial of the effects of rosiglitazone and metformin on inflammation and subclinical atherosclerosis in patients with type 2 diabetes. Am. Heart J. 153, 445 e1 (2007) https://doi.org/10.1016/j.ahj.2006.11.005
  54. Viljanen, A. P., Virtanen, K. A., Jarvisalo, M. J., Hallsten, K., Parkkola, R., Ronnemaa, T., Lonnqvist, F., Iozzo, P., Ferrannini, E. and Nuutila, P. : Rosiglitazone treatment increases subcutaneous adipose tissue glucose uptake in parallel with perfusion in patients with type 2 diabetes: a double-blind, randomized study with metformin. J. Clin. Endocrinol. Metab. 90, 6523 (2005) https://doi.org/10.1210/jc.2005-1073
  55. Vongthavaravat, V., Wajchenberg, B. L., Waitman, J. N., Quimpo, J. A., Menon, P. S., Ben Khalifa, F. and Chow, W. H. : An international study of the effects of rosiglitazone plus sulphonylurea in patients with type 2 diabetes. Curr. Med. Res.Opin. 18, 456 (2002) https://doi.org/10.1185/030079902125001236
  56. Weissman, P., Goldstein, B. J., Rosenstock, J., Waterhouse, B., Cobitz, A. R., Wooddell, M. J. and Strow, L. J. : Effects of rosiglitazone added to submaximal doses of metformin compared with dose escalation of metformin in type 2 diabetes: the EMPIRE study. Curr. Med. Res. Opin. 21, 2029 (2005) https://doi.org/10.1185/030079905X74844
  57. Wolffenbuttel, B. H., Gomis, R., Squatrito, S., Jones, N. P. and Patwardhan, R. N. : Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in type 2 diabetic patients. Diabet Med. 17, 40 (2000) https://doi.org/10.1046/j.1464-5491.2000.00224.x
  58. Yang, W. S., Jeng, C. Y., Wu, T. J., Tanaka, S., Funahashi, T., Matsuzawa, Y., Wang, J. P., Chen, C. L., Tai, T. Y. and Chuang, L. M. : Synthetic peroxisome proliferator-activated receptorgamma agonist, rosiglitazone, increases plasma levels of adiponectin in type 2 diabetic patients. Diabetes Care. 25, 376 (2002) https://doi.org/10.2337/diacare.25.2.376
  59. Yilmaz, H., Gursoy, A., Sahin, M. and Guvener Demirag, N. : Comparison of insulin monotherapy and combination therapy with insulin and metformin or insulin and rosiglitazone or insulin and acarbose in type 2 diabetes. Acta Diabetol. 44, 187 (2007) https://doi.org/10.1007/s00592-007-0004-9
  60. Yu, D., Murdoch, S. J., Parikh, S. J., Marcovina, S. M., Cobitz, A., Chen, H. and Brunzell, J. D. : Rosiglitazone increases LDL particle size and buoyancy and decreases C-reactive protein in patients with type 2 diabetes on statin therapy. Diab. Vasc. Dis. Res. 3, 189 (2006) https://doi.org/10.3132/dvdr.2006.029
  61. Zhu, X. X., Pan, C. Y., Li, G. W., Shi, H. L., Tian, H., Yang, W. Y., Jiang, J., Sun, X. C., Davies, C. and Chow, W. H. : Addition of rosiglitazone to existing sulfonylurea treatment in chinese patients with type 2 diabetes and exposure to hepatitis B or C. Diabetes Technol. Ther. 5, 33 (2003) https://doi.org/10.1089/152091503763816445