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fbtwitterlinkedinvimeoflicker grey 14rssslideshare1
Publisher: Cochrane Collaboration
Languages: English
Types: Article
Subjects:
Diabetes has long been recognised as a strong, independent risk factor for cardiovascular disease, a problem which accounts for approximately 70% of all mortality in people with diabetes. Prospective studies show that compared to their non-diabetic counterparts, the relative risk of cardiovascular mortality for men with diabetes is two to three and for women with diabetes is three to four. The two biggest trials in type 2 diabetes, the United Kingdom Prospective Diabetes Study (UKPDS) and the University Group Diabetes Program (UGDP) study did not reveal a reduction of cardiovascular endpoints through improved metabolic control. Theoretical benefits of the peroxisome proliferator activated receptor gamma (PPAR-gamma) activator rosiglitazone on endothelial function and cardiovascular risk factors might result in fewer macrovascular disease events in people with type 2 diabetes mellitus. To assess the effects of rosiglitazone in the treatment of type 2 diabetes. Studies were obtained from computerised searches of MEDLINE, EMBASE and The Cochrane Library. Studies were included if they were randomised controlled trials in adult people with type 2 diabetes mellitus and had a trial duration of at least 24 weeks. Two authors independently assessed trial quality and extracted data. Pooling of studies by means of fixed-effects meta-analysis could be performed for adverse events only. Eighteen trials which randomised 3888 people to rosiglitazone treatment were identified. Longest duration of therapy was four years with a median of 26 weeks. Published studies of at least 24 weeks rosiglitazone treatment in people with type 2 diabetes mellitus did not provide evidence that patient-oriented outcomes like mortality, morbidity, adverse effects, costs and health-related quality of life are positively influenced by this compound. Metabolic control measured by glycosylated haemoglobin A1c (HbA1c) as a surrogate endpoint did not demonstrate clinically relevant differences to other oral antidiabetic drugs. Occurrence of oedema was significantly raised (OR 2.27, 95% confidence interval (CI) 1.83 to 2.81). The single large RCT (ADOPT - A Diabetes Outcomes Progression Trial) indicated increased cardiovascular risk. New data on raised fracture rates in women reveal extensive action of rosiglitazone in various body tissues. New studies should focus on patient-oriented outcomes to clarify the benefit-risk ratio of rosiglitazone therapy. Safety data and adverse events of all investigations (published and unpublished) should be made available to the public.
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    • Derosa 2004 {published data only} Derosa G, Cicero AFG, D'Angelo A, Gaddi A, Ragonesi PD, Piccinni MN, Salvadeo S, Ciccarelli L, Pricolo F, Ghelfi M, Ferrari I, Montagna L, Fogari R. Thiazolidinedione effects on blood pressure in diabetic patients with metabolic syndrome treated with glimepiride. Hypertension Research 2005;28(11):917-924.
    • ∗ Derosa G, Cicero AFG, Gaddi A, Ragonesi PD, Fogari E, Bertone G, et al.Metabolic effects of pioglitazone and rosiglitazone in patients with diabetes and metabolic syndrome treated with glimepiride: A twelve-month, multicenter, double-blind, randomized, controlled, parallelgroup trial. Clinical Therapeutics 2004;26(5):744-54.
    • Derosa G, Cicero AFG, Gaddi A, Ragonesi PD, Piccinni MN, Fogari E, Salvadeo S, Ciccarelli L, Fogari R. A comparison of the effects of pioglitazone and rosiglitazone combined with glimepiride on prothrombotic state in type 2 diabetic patients with the metabolic syndrome. Diabetes Research & Clinical Practice 2005;69(1):5-13.
    • Derosa 2006a {published data only} Derosa G, Angelo AD, Ragonesi PD, Ciccarelli L, Piccini MN, Pricolo F, et al.Metformin-pioglitazone and metformin-rosiglitazone effects on non-conventional cardiovascular risk factors plasma level in type 2 diabetic patients with metabolic syndrome. Journal of Clinical Pharmacology and Therapeutics 2006;31:375-83.
    • ∗ Derosa G, D'Angelo A, Ragonesi PD, Ciccarelli L, Piccinni MN, Pricolo F, et al.Metabolic effects of pioglitazone and rosiglitazone in patients with diabetes and metabolic syndrome treated with metformin. Internal Medicine Journal 2007;37:79-86.
    • Derosa 2006b {published data only} Derosa G, Cicero AFG, Gaddi AV, Ciccarelli L, Piccinni MN, Salvadeo S, et al.Long-term effects of glimepiride or rosiglitazone in combination with metformin on blood pressure control in type 2 diabetic patients affected by the metabolic syndrome: a 12-month, double-blind, randomized trial. Clinical Therapeutics 2005;27(9): 1383-90.
    • Journal of International Medical Research 2005;33(3): 284-94.
    • Derosa G, Gaddi AV, Piccinni MN, Ciccarelli L, Salvadeo S, Peros E, et al.Antithrombotic effects of rosiglitazonemetformin versus glimepiride-metformin combination therapy in patients with type 2 diabetes mellitus and metabolic syndrome. Pharmacotherapy 2005;25(5 I): 637-45.
    • ∗ Derosa G, Gaddi AV, Piccinni MN, Salvadeo S, Ciccarelli L, Fogari E, et al.Differential effect of glimepiride and rosiglitazone on metabolic control of type 2 diabetic patients treated with metformin: a randomized, doubleblind, clinical trial. Diabetes, Obesity and Metabolism 2006; 8:197-205.
    • Garber 2006 {published data only} Garber A, Klein E, Bruce S, Sankoh S, Mohideen P. Metformin-glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Diabetes, Obesity and Metabolism 2006;8:156-63.
    • Goldberg 2005 {published data only} Goldberg RB, Kendall DM, Deeg MA, Buse JB, Zagar AJ, Pinaire JA, 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 (7):1547-54.
    • Hanefeld 2007 {published data only} Hanefeld M, Patwardhan R, Jones NP, Rosiglitazone Clinical Trials Study Group. A one-year study comparing the efficacy and safety of rosiglitazone and glibenclamide in the treatment of type 2 diabetes. Nutrition, Metabolism, and Cardiovascular Diseases 2007;17(1):13-23.
    • Hällsten 2002 {published data only} Hällsten K, Virtanen KA, Lonnqvistt F, Janatuinen T, Turiceanu M, Ronnemaa T, et al.Enhancement of insulinstimulated myocardial glucose uptake in patients with Type 2 diabetes treated with rosiglitazone. Diabetic Medicine 2004;21(12):1280-7.
    • ∗ Hällsten K, Virtanen KI, Lönnqvist F, Sipilä H, Oksanen A, Viljanen T, et al.Rosiglitazone but not metformin enhances insulin- and exercise-stimulated skeletal muscle glucose uptake in patients with newly diagnosed type 2 diabetes. Diabetes 2002;51:3479-85.
    • Iozzo P, Hallsten K, Oikonen V, Virtanen KA, Parkkola R, Kemppainen J, et al.Effects of metformin and rosiglitazone monotherapy on insulin-mediated hepatic glucose uptake and their relation to visceral fat in type 2 diabetes. Diabetes Care. 26 2003; Vol. 26, issue 7:2069-74.
    • Karlsson HK, Hallsten K, Bjornholm M, Tsuchida H, Chibalin AV, Virtanen KA, et al.Effects of metformin and rosiglitazone treatment on insulin signaling and glucose uptake in patients with newly diagnosed type 2 diabetes: a randomized controlled study. Diabetes 2005;54(5): 1459-67.
    • Viljanen APM, Virtanen KA, Järvisalo MJ, Hällsten K, Parkkola R, Rönnemaa T, et al.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. Journal of Clinical Endocrinology & Metabolism 2005;90(12):6523-8.
    • Virtanen KA, Hallsten K, Parkkola R, Janatuinen T, Lonnqvist F, Viljanen T, et al.Differential effects of rosiglitazone and metformin on adipose tissue distribution Jung 2005 {published data only} Jung HS, Youn BS, Cho YM, Yu KY, Park HJ, Shin CS, et al.The effects of rosiglitazone and metformin on the plasma concentrations of resistin in patients with type 2 diabetes mellitus. Metabolism: Clinical and Experimental 2005;54 (3):314-20.
    • Kahn 2006 {published data only} Correction to Kahn, et al.N Engl J Med 355(23):2427-2443 December 7, 2006. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. New England Journal of Medicine 2007;356(13):1387-8.
    • Gandhi GY, Montori VM. Glycemic durability of monotherapy for diabetes. New England Journal of Medicine 2007;356(13):1378-80.
    • ∗ Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, et al.ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. New England Journal of Medicine 2006;355 (23):2427-43.
    • Nathan DM. Thiazolidinediones for initial treatment of type 2 diabetes?. New England Journal of Medicine 2006; 355(23):2477-80.
    • Viberti G, Kahn SE, Greene DA, Herman WH, Zinman B, Holman RR, et al.A Diabetes Outcome Progression Trial (ADOPT): An international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Diabetes Care 2002;25:1737-43.
    • Viberti G, Lachin J, Holman R, Zinman B, Haffner S, Kravitz MA, et al.A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of Type 2 diabetic patients in North America and Europe. Diabetic Medicine 2006;23(12):1289-94.
    • Ko 2006 {published data only} Ko GT, Tsang PC, Wai HP, Kan EC, Chan HC.
    • Rosiglitazone versus bedtime insulin in the treatment of patients with conventional oral antidiabetic drug failure: a 1-year randomized clinical trial. Advances in Therapy 2006; 23(5):799-808.
    • Lebovitz 2001 {published data only} Haffner SM, Greenberg AS, Weston WM, Chen H, Williams K, Freed MI. Effect of rosiglitazone treatment on nontraditional markers of cardiovascular disease in patients with type 2 diabetes mellitus. Circulation 2002;106(6): 679-84.
    • ∗ Lebovitz HE, Dole JF, Patwardhan R, Rappaport EB, Freed MI. Rosiglitazone monotherapy is effective in patients with type 2 diabetes. Journal of Clinical Endocrinology & Metabolism 2001;86(1):280-8.
    • Ovalle 2004 {published data only} Ovalle F, Bell DSH. Effect of rosiglitazone versus insulin on the pancreatic beta-cell function of subjects with type 2 diabetes. Diabetes Care 2004;27(11):2585-9.
    • Phillips 2001 {published data only} Phillips LS, Grunberger G, Miller E, Patwardhan R, Rappaport EB, Salzman A. Once- and twice-daily dosing with rosiglitazone improves glycemic control in patients with type 2 diabetes. Diabetes Care 2001;24(2):308-15.
    • Raskin 2004 {published data only} Raskin P, McGill J, Saad MF, Cappleman JM, Kaye W, Khutoryansky N et al - for the Repaglinide/Rosiglitazone Study Group. Combination therapy for type 2 diabetes: repaglinide plus rosiglitazone. Diabetic Medicine 2004;21: 329-35.
    • Rosenstock 2006b {published data only} Rosenstock J, Sugimoto D, Strange P, Stewart JA, SoltesRak E, Dailey G - on behalf of the Insulin Glargine 4014 Study Investigators. Insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care 2006;29:554-9.
    • Stocker 2007 {published data only} Stocker DJ, Taylor AJ, Langley RW, Jezior MR, Vigersky RA. A randomized trial of the effects of rosiglitazone and metformin on inflammation and subclinical atherosclerosis in patients with type 2 diabetes. American Heart Journal 2007;153(3):445.e1-6.
    • Sutton 2002 {published data only} Bakris G, Viberti G, Weston WM, Heise M, Porter LE, Freed MI. Rosiglitazone reduces urinary albumin excretion in type II diabetes. Journal of Human Hypertension 2003;17 (1):7-12.
    • ∗ John Sutton M, Rendell M, Dandona P, Dole JF, Murphy K, Patwardhan R, et al.A comparison of the effects of rosiglitazone and glyburide on cardiovascular function and glycemic control in patients with type 2 diabetes. Diabetes Care 2002;25(11):2058-64.
    • Yang 2002 {published data only} Yang W-S, Jeng C-Y, Wu T-J, Tanaka S, Funahashi T, Matsuzawa Y, et al.Synthetic peroxisome proliferatoractivated receptor-gamma agonist, rosiglitazone, increases plasma levels of adiponectin in type 2 diabetic patients.
    • Diabetes Care 2002;25(2):376-80.
    • Bailey 2005 {published data only} Bailey CJ, Bagdonas A, Rubes J, McMorn SO, Donaldson J, Biswas N, et al.Rosiglitazone/metformin fixed-dose combination compared with uptitrated metformin alone in type 2 diabetes mellitus: a 24-week, multicenter, randomized, double-blind, parallel-group study. Clinical Therapeutics 2005;27(10):1548-61.
    • Baksi 2004 {published data only} Baksi A, James RE, Zhou B, Nolan JJ. 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 Diabetologica 2004;41(2):63-9. [MEDLINE: 474] A U T H
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