Glycemic Durability of Rosiglitazone, Metformin, or Glyburide Monotherapy
Steven E. Kahn, M.B., Ch.B., Steven M. Haffner, M.D., Mark A. Heise, Ph.D., William H. Herman, M.D., M.P.H., Rury R. Holman, F.R.C.P., Nigel P. Jones, M.A., Barbara G. Kravitz, M.S., John M. Lachin, Sc.D., M. Colleen O'Neill, B.Sc., Bernard Zinman, M.D., F.R.C.P.C., Giancarlo Viberti, M.D., F.R.C.P., for the ADOPT Study Group
Background The efficacy of thiazolidinediones, as compared withother oral glucose-lowering medications, in maintaining long-termglycemic control in type 2 diabetes is not known.
Methods We evaluated rosiglitazone, metformin, and glyburideas initial treatment for recently diagnosed type 2 diabetesin a double-blind, randomized, controlled clinical trial involving4360 patients. The patients were treated for a median of 4.0years. The primary outcome was the time to monotherapy failure,which was defined as a confirmed level of fasting plasma glucoseof more than 180 mg per deciliter (10.0 mmol per liter), forrosiglitazone, as compared with metformin or glyburide. Prespecifiedsecondary outcomes were levels of fasting plasma glucose andglycated hemoglobin, insulin sensitivity, and -cell function.
Results Kaplan–Meier analysis showed a cumulative incidenceof monotherapy failure at 5 years of 15% with rosiglitazone,21% with metformin, and 34% with glyburide. This representsa risk reduction of 32% for rosiglitazone, as compared withmetformin, and 63%, as compared with glyburide (P<0.001 forboth comparisons). The difference in the durability of the treatmenteffect was greater between rosiglitazone and glyburide thanbetween rosiglitazone and metformin. Glyburide was associatedwith a lower risk of cardiovascular events (including congestiveheart failure) than was rosiglitazone (P<0.05), and the riskassociated with metformin was similar to that with rosiglitazone.Rosiglitazone was associated with more weight gain and edemathan either metformin or glyburide but with fewer gastrointestinalevents than metformin and with less hypoglycemia than glyburide(P<0.001 for all comparisons).
Conclusions The potential risks and benefits, the profile ofadverse events, and the costs of these three drugs should allbe considered to help inform the choice of pharmacotherapy forpatients with type 2 diabetes. (ClinicalTrials.gov number, NCT00279045
[ClinicalTrials.gov]
.)
Source Information
From the Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle (S.E.K.); University of Texas Health Science Center at San Antonio, San Antonio (S.M.H.); GlaxoSmithKline, King of Prussia, PA (M.A.H., B.G.K., M.C.O.), and Harlow, Essex, United Kingdom (N.P.J.); University of Michigan, Ann Arbor (W.H.H.); Oxford Centre for Diabetes, Endocrinology, and Metabolism, Oxford, United Kingdom (R.R.H.); the Biostatistics Center, George Washington University, Rockville, MD (J.M.L.); Samuel Lunenfeld Research Institute, Mount Sinai Hospital and University of Toronto, Toronto (B.Z.); and King's College London School of Medicine, University of London, London (G.V.). This article was published at www.nejm.org on December 4, 2006.
Address reprint requests to Dr. Kahn at the Veterans Affairs Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA 98108, or at skahn{at}u.washington.edu.
Glycemic Durability of Monotherapy for Diabetes
Rathmann W., Kostev K., Haastert B., Parashar A., Varma A., Garg R., Gandhi G. Y., Montori V. M., Kahn S. E., Viberti G., the ADOPT Steering Committee
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N Engl J Med 2007;
356:1378-1380, Mar 29, 2007.
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A correction has been published: N Engl J Med 2007;356(13):1387.
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