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Original Studies |
Department of Medicine, State University of New York (H.E.L.), Brooklyn, New York 11203; and SmithKline Beecham Pharmaceuticals (J.F.D., R.P., E.B.R., M.I.F.), Collegeville, Pennsylvania
Address all correspondence and requests for reprints to: Harold E. Lebovitz, M.D., Department of Medicine, Division of Endocrinology, State University of New York Health Science Center, 450 Clarkson Avenue, Box 50, Brooklyn, New York 11203. E-mail: hlebovitz{at}attglobal.net
This study evaluated the efficacy and safety of rosiglitazone monotherapy in patients with type 2 diabetes. After a 4-week placebo run-in period, 493 patients with type 2 diabetes were randomized to receive rosiglitazone [2 or 4 mg twice daily (bd)] or placebo for 26 weeks. The primary end point was change in hemoglobin A1c; other variables assessed included fasting plasma glucose, fructosamine, endogenous insulin secretion, urinary albumin excretion, serum lipids, and adverse events. Rosiglitazone (2 and 4 mg bd) decreased mean hemoglobin A1c relative to placebo by 1.2 and 1.5 percentage points, respectively, and reduced fasting plasma glucose concentrations relative to placebo by 3.22 and 4.22 mmol/L, respectively. Fasting plasma insulin and insulin precursor molecules decreased significantly. Homeostasis model assessment estimates indicate that rosiglitazone (2 and 4 mg bd) reduced insulin resistance by 16.0% and 24.6%, respectively, and improved ß-cell function over baseline by 49.5% and 60.0%, respectively. Urinary albumin excretion decreased significantly in the rosiglitazone (4 mg bd) group. There was no increase in adverse events with rosiglitazone. In the short-term, rosiglitazone is an insulin sensitizer that is effective and safe as monotherapy in patients with type 2 diabetes who are inadequately controlled by lifestyle interventions.
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V. De Leo, A. la Marca, and F. Petraglia Insulin-Lowering Agents in the Management of Polycystic Ovary Syndrome Endocr. Rev., October 1, 2003; 24(5): 633 - 667. [Abstract] [Full Text] [PDF]
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J. P.H. van Wijk, E. J.P. de Koning, E. P. Martens, and T. J. Rabelink Thiazolidinediones and Blood Lipids in Type 2 Diabetes Arterioscler. Thromb. Vasc. Biol., October 1, 2003; 23(10): 1744 - 1749. [Abstract] [Full Text] [PDF]
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V. Fonseca, G. Grunberger, S. Gupta, S. Shen, and J. E. Foley Addition of Nateglinide to Rosiglitazone Monotherapy Suppresses Mealtime Hyperglycemia and Improves Overall Glycemic Control Diabetes Care, June 1, 2003; 26(6): 1685 - 1690. [Abstract] [Full Text] [PDF]
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 J. Tuepker, S. M. Haffner, K. Williams, A. S. Greenberg, W. M. Weston, H. Chen, and M. I. Freed Effect of Rosiglitazone Treatment on Nontraditional Markers of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus * Response Circulation, April 29, 2003; 107 (16): e109 - e109. [Full Text] [PDF]
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I. Pavo, G. Jermendy, T. T. Varkonyi, Z. Kerenyi, A. Gyimesi, S. Shoustov, M. Shestakova, M. Herz, D. Johns, B. J. Schluchter, 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., April 1, 2003; 88(4): 1637 - 1645. [Abstract] [Full Text] [PDF]
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M. C. Chapelsky, K. Thompson-Culkin, A. K. Miller, M. Sack, R. Blum, and M. I. Freed Pharmacokinetics of Rosiglitazone in Patients with Varying Degrees of Renal Insufficiency J. Clin. Pharmacol., March 1, 2003; 43(3): 252 - 259. [Abstract] [Full Text] [PDF]
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K. A. Virtanen, K. Hallsten, R. Parkkola, T. Janatuinen, F. Lonnqvist, T. Viljanen, T. Ronnemaa, J. Knuuti, R. Huupponen, P. Lonnroth, et al. Differential Effects of Rosiglitazone and Metformin on Adipose Tissue Distribution and Glucose Uptake in Type 2 Diabetic Subjects Diabetes, February 1, 2003; 52(2): 283 - 290. [Abstract] [Full Text] [PDF]
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K. Starkey, A. Heufelder, G. Baker, W. Joba, M. Evans, S. Davies, and M. Ludgate Peroxisome Proliferator-Activated Receptor-{gamma} in Thyroid Eye Disease: Contraindication for Thiazolidinedione Use? J. Clin. Endocrinol. Metab., January 1, 2003; 88(1): 55 - 59. [Abstract] [Full Text] [PDF]
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M. St. John Sutton, M. Rendell, P. Dandona, J. F. Dole, K. Murphy, R. Patwardhan, J. Patel, and M. Freed A Comparison of the Effects of Rosiglitazone and Glyburide on Cardiovascular Function and Glycemic Control in Patients With Type 2 Diabetes Diabetes Care, November 1, 2002; 25(11): 2058 - 2064. [Abstract] [Full Text] [PDF]
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G. Viberti, S. E. Kahn, D. A. Greene, W. H. Herman, B. Zinman, R. R. Holman, S. M. Haffner, D. Levy, J. M. Lachin, R. A. Berry, 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, October 1, 2002; 25(10): 1737 - 1743. [Abstract] [Full Text] [PDF]
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S. M. Haffner, A. S. Greenberg, W. M. Weston, H. Chen, K. Williams, and M. I. Freed Effect of Rosiglitazone Treatment on Nontraditional Markers of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus Circulation, August 6, 2002; 106(6): 679 - 684. [Abstract] [Full Text] [PDF]
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 S. E. Inzucchi Oral Antihyperglycemic Therapy for Type 2 Diabetes: Scientific Review JAMA, January 16, 2002; 287(3): 360 - 372. [Abstract] [Full Text] [PDF]
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W. A. Hsueh and R. E. Law PPAR{gamma} and Atherosclerosis: Effects on Cell Growth and Movement Arterioscler. Thromb. Vasc. Biol., December 1, 2001; 21(12): 1891 - 1895. [Abstract] [Full Text] [PDF]
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C. J Bailey and C. Day Review: Thiazolidinediones today The British Journal of Diabetes & Vascular Disease, August 1, 2001; 1(1): 7 - 13. [Abstract] [PDF]
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P. Raskin, M. Rendell, M. C. Riddle, J. F. Dole, M. I. Freed, and J. Rosenstock A Randomized Trial of Rosiglitazone Therapy in Patients With Inadequately Controlled Insulin-Treated Type 2 Diabetes Diabetes Care, July 1, 2001; 24(7): 1226 - 1232. [Abstract] [Full Text] [PDF]
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